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2.
Am J Hypertens ; 34(8): 783-794, 2021 08 09.
Artigo em Inglês | MEDLINE | ID: mdl-34431500

RESUMO

Home blood pressure monitoring (HBPM) is a reliable, convenient, and less costly alternative to ambulatory blood pressure monitoring (ABPM) for the diagnosis and management of hypertension. Recognition and use of HBPM have dramatically increased over the last 20 years and current guidelines make strong recommendations for the use of both HBPM and ABPM in patients with hypertension. The accuracy and reliability of home blood pressure (BP) measurements require use of a validated device and standardized procedures, and good patient information and training. Key HBPM parameters include morning BP, evening BP, and the morning-evening difference. In addition, newer semi-automatic HBPM devices can also measure nighttime BP at fixed intervals during sleep. Advances in technology mean that HBPM devices could provide additional relevant data (e.g., environmental conditions) or determine BP in response to a specific trigger (e.g., hypoxia, increased heart rate). The value of HBPM is highlighted by a growing body of evidence showing that home BP is an important predictor of target organ damage, and cardiovascular disease (CVD)- and stroke-related morbidity and mortality, and provides better prognostic information than office BP. In addition, use of HBPM to monitor antihypertensive therapy can help to optimize reductions in BP, improve BP control, and reduce target organ damage and cardiovascular risk. Overall, HBPM should play a central role in the management of patients with hypertension, with the goal of identifying increased risk and predicting the onset of CVD events, allowing proactive interventions to reduce risk and eliminate adverse outcomes.


Assuntos
Monitorização Ambulatorial da Pressão Arterial , Hipertensão , Monitorização Ambulatorial da Pressão Arterial/tendências , Humanos , Hipertensão/diagnóstico , Hipertensão/prevenção & controle , Reprodutibilidade dos Testes
3.
Laryngoscope ; 131(9): 2126-2132, 2021 09.
Artigo em Inglês | MEDLINE | ID: mdl-33599298

RESUMO

OBJECTIVE: To evaluate blood pressure (BP) variability in 24-hour ambulatory BP monitoring in children with obstructive sleep apnea (OSA). STUDY DESIGN: Case series study. METHODS: Children aged 4 to 16 years with clinical symptoms were recruited in a tertiary medical center. Overnight polysomnography and 24-hour recordings of ambulatory BP were performed for each child. The severity of OSA was classified as primary snoring (apnea-hypopnea index [AHI] < 1), mild OSA (1 ≤ AHI < 5), moderate OSA (10 > AHI ≥ 5), and severe OSA (AHI ≥ 10). The standard deviation of mean BP was used as an indicator of BP variability. RESULTS: A total of 550 children were included (mean age: 7.6 years; 70% were boys; 20% were obese). Compared with the children with primary snoring, children with severe OSA exhibited significantly higher nighttime systolic BP (108.0 vs. 100.5 mmHg, P < .001), nighttime diastolic BP (58.9 vs 55.6 mmHg, P = .002), nighttime mean arterial pressure (75.3 vs. 70.5 mmHg, P < .001), nighttime systolic BP load (40.5% vs. 25.0%, P < .001), nighttime diastolic BP load (25.3% vs. 12.9%, P < .001), and nighttime systolic BP variability (11.4 vs. 9.6, P = .001). Multiple linear regression analyses revealed an independent association between AHI and nighttime systolic BP variability (regression coefficient = 0.31, 95% CI = 0.06-0.56, P = .015) after adjustment for age, gender, adiposity, and hypertensive status. CONCLUSIONS: OSA in children is associated with increased BP and BP variability. LEVEL OF EVIDENCE: 4 Laryngoscope, 131:2126-2132, 2021.


Assuntos
Variação Biológica da População/fisiologia , Monitorização Ambulatorial da Pressão Arterial/tendências , Pressão Sanguínea/fisiologia , Polissonografia/métodos , Apneia Obstrutiva do Sono/fisiopatologia , Adolescente , Monitorização Ambulatorial da Pressão Arterial/estatística & dados numéricos , Criança , Pré-Escolar , Diástole , Feminino , Humanos , Hipertensão/complicações , Hipertensão/epidemiologia , Masculino , Obesidade/complicações , Obesidade/epidemiologia , Projetos Piloto , Análise de Regressão , Índice de Gravidade de Doença , Apneia Obstrutiva do Sono/diagnóstico , Apneia Obstrutiva do Sono/epidemiologia , Apneia Obstrutiva do Sono/etiologia , Sístole
4.
Lancet Neurol ; 19(11): 899-907, 2020 11.
Artigo em Inglês | MEDLINE | ID: mdl-33098800

RESUMO

BACKGROUND: Results from the Systolic Blood Pressure Intervention Trial (SPRINT) showed that intensive control of systolic blood pressure significantly reduced the occurrence of mild cognitive impairment, but not probable dementia. We investigated the effects of intensive lowering of systolic blood pressure on specific cognitive functions in a preplanned substudy of participants from SPRINT. METHODS: SPRINT was an open-label, multicentre, randomised controlled trial undertaken at 102 sites, including academic medical centres, Veterans Affairs medical centres, hospitals, and independent clinics, in the USA and Puerto Rico. Participants were adults aged 50 years or older with systolic blood pressure higher than 130 mm Hg, but without diabetes, history of stroke, or dementia. Participants were randomly assigned (1:1) to a systolic blood pressure goal of less than 120 mm Hg (intensive treatment) versus less than 140 mm Hg (standard treatment). All major classes of antihypertensive agents were included. A subgroup of randomly assigned participants including, but not limited to, participants enrolled in an MRI substudy was then selected for a concurrent substudy of cognitive function (target 2800 participants). Each individual was assessed with a screening cognitive test battery and an extended cognitive test battery at baseline and biennially during the planned 4-year follow-up. The primary outcomes for this substudy were standardised composite scores for memory (Logical Memory I and II, Modified Rey-Osterrieth Complex Figure [immediate recall], and Hopkins Verbal Learning Test-Revised [delayed recall]) and processing speed (Trail Making Test and Digit Symbol Coding). SPRINT was registered with ClinicalTrials.gov, NCT01206062. FINDINGS: From Nov 23, 2010, to Dec 28, 2012, 2921 participants (mean age 68·4 years [SD 8·6], 1080 [37%] women) who had been randomly assigned in SPRINT were enrolled in the substudy (1448 received intensive treatment and 1473 received standard treatment). SPRINT was terminated early due to benefit observed in the primary outcome (composite of cardiovascular events). After a median follow-up of 4·1 years (IQR 3·7-5·8), there was no between-group difference in memory, with an annual decline in mean standardised domain score of -0·005 (95% CI -0·010 to 0·001) in the intensive treatment group and -0·001 (-0·006 to 0·005) in the standard treatment group (between-group difference -0·004, 95% CI -0·012 to 0·004; p=0·33). Mean standardised processing speed domain scores declined more in the intensive treatment group (between-group difference -0·010, 95% CI -0·017 to -0·002; p=0·02), with an annual decline of -0·025 (-0·030 to -0·019) for the intensive treatment group and -0·015 (-0·021 to 0·009) for the standard treatment group. INTERPRETATION: Intensive treatment to lower systolic blood pressure did not result in a clinically relevant difference compared with standard treatment in memory or processing speed in a subgroup of participants from SPRINT. The effect of blood pressure lowering might not be evident in specific domains of cognitive function, but instead distributed across multiple domains. FUNDING: National Heart, Lung, and Blood Institute, National Institute of Diabetes and Digestive and Kidney Diseases, National Institute on Aging, National Institute of Neurological Disorders and Stroke, and the Alzheimer's Association.


Assuntos
Anti-Hipertensivos/uso terapêutico , Pressão Sanguínea/efeitos dos fármacos , Cognição/efeitos dos fármacos , Hipertensão/tratamento farmacológico , Hipertensão/epidemiologia , Testes de Estado Mental e Demência , Idoso , Idoso de 80 Anos ou mais , Anti-Hipertensivos/farmacologia , Pressão Sanguínea/fisiologia , Monitorização Ambulatorial da Pressão Arterial/métodos , Monitorização Ambulatorial da Pressão Arterial/tendências , Cognição/fisiologia , Disfunção Cognitiva/epidemiologia , Disfunção Cognitiva/prevenção & controle , Disfunção Cognitiva/psicologia , Feminino , Seguimentos , Humanos , Hipertensão/psicologia , Masculino , Pessoa de Meia-Idade , Resultado do Tratamento , Estados Unidos/epidemiologia , United States Department of Veterans Affairs/tendências
5.
Hypertension ; 76(3): 640-650, 2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-32755418

RESUMO

Out-of-office blood pressure measurement is an essential part of diagnosing and managing hypertension. In the era of advanced digital health information technology, the approach to achieving this is shifting from traditional methods (ambulatory and home blood pressure monitoring) to wearable devices and technology. Wearable blood pressure monitors allow frequent blood pressure measurements (ideally continuous beat-by-beat monitoring of blood pressure) with minimal stress on the patient. It is expected that wearable devices will dramatically change the quality of detection and management of hypertension by increasing the number of measurements in different situations, allowing accurate detection of phenotypes that have a negative impact on cardiovascular prognosis, such as masked hypertension and abnormal blood pressure variability. Frequent blood pressure measurements and the addition of new features such as monitoring of environmental conditions allows interpretation of blood pressure data in the context of daily stressors and different situations. This new digital approach to hypertension contributes to anticipation medicine, which refers to strategies designed to identify increasing risk and predict the onset of cardiovascular events based on a series of data collected over time, allowing proactive interventions to reduce risk. To achieve this, further research and validation is required to develop wearable blood pressure monitoring devices that provide the same accuracy as current approaches and can effectively contribute to personalized medicine.


Assuntos
Monitores de Pressão Arterial , Hipertensão/diagnóstico , Tecnologia de Sensoriamento Remoto , Dispositivos Eletrônicos Vestíveis , Monitorização Ambulatorial da Pressão Arterial/tendências , Humanos , Prognóstico , Tecnologia de Sensoriamento Remoto/instrumentação , Tecnologia de Sensoriamento Remoto/métodos
8.
BMC Fam Pract ; 21(1): 95, 2020 05 26.
Artigo em Inglês | MEDLINE | ID: mdl-32456619

RESUMO

BACKGROUND: Hypertension is the most common chronic disease and is the leading cause of morbidity and mortality. Its screening, diagnosis, and management depend heavily on accurate blood pressure (BP) measurement. It is recommended that the diagnosis of hypertension should be confirmed or corroborated by out-of-office BP values, measured using ambulatory BP monitoring (ABPM) and home BP monitoring (HBPM). When office BP is used, automated office BP (AOBP) measurement method, which automatically provides an average of 3-5 BP readings, should be preferred. This study aimed to describe the BP measurement methods commonly used by doctors in primary care in Hong Kong, to screen, diagnose, and manage hypertensive patients. METHODS: In this cross-sectional survey, all doctors registered in the Hong Kong "Primary Care Directory" were mailed a questionnaire, asking their preferred BP-measuring methods to screen, diagnose, and manage hypertensive patients. Furthermore, we also elicited information on the usual number of office BP or HBPM readings obtained, to diagnose or manage hypertension. RESULTS: Of the 1738 doctors included from the directory, 445 responded. Manual measurement using a mercury or aneroid device was found to be the commonest method to screen (63.1%), diagnose (56.4%), and manage (72.4%) hypertension. There was a significant underutilisation of ABPM, with only 1.6% doctors using this method to diagnose hypertension. HBPM was used by 22.2% and 56.8% of the respondents to diagnose and manage hypertension, respectively. A quarter (26.7%) of the respondents reported using only one in-office BP reading, while around 40% participants reported using ≥12 HBPM readings. Doctors with specialist qualification in family medicine were more likely to use AOBP in clinics and to obtain the recommended number of office BP readings for diagnosis and management of hypertension. CONCLUSION: Primary Care doctors in Hong Kong prefer to use manual office BP values, measured using mercury or aneroid devices, to screen, diagnose, and manage hypertension, highlighting a marked underutilisation of AOBP and out-of-office BP measuring techniques, especially that of ABPM. Further studies are indicated to understand the underlying reasons and to minimise the gap between real-life clinical practice and those recommended, based on scientific advances. TRIAL REGISTRATION: Clinicaltrial.gov; ref. no.: NCT03926897.


Assuntos
Monitorização Ambulatorial da Pressão Arterial , Hipertensão , Atenção Primária à Saúde , Esfigmomanômetros/classificação , Monitorização Ambulatorial da Pressão Arterial/instrumentação , Monitorização Ambulatorial da Pressão Arterial/métodos , Monitorização Ambulatorial da Pressão Arterial/tendências , Estudos Transversais , Precisão da Medição Dimensional , Feminino , Hong Kong/epidemiologia , Humanos , Hipertensão/diagnóstico , Hipertensão/epidemiologia , Masculino , Pessoa de Meia-Idade , Visita a Consultório Médico/estatística & dados numéricos , Preferência do Paciente/estatística & dados numéricos , Atenção Primária à Saúde/métodos , Atenção Primária à Saúde/normas , Atenção Primária à Saúde/tendências , Utilização de Procedimentos e Técnicas/estatística & dados numéricos
9.
Health Aff (Millwood) ; 39(1): 124-132, 2020 01.
Artigo em Inglês | MEDLINE | ID: mdl-31905068

RESUMO

There is considerable policy interest in home-based screening campaigns for hypertension in many low- and middle-income countries. However, it is unclear whether such efforts will result in long-term population-level blood pressure improvements without more comprehensive interventions that strengthen the entire hypertension care continuum. Using multiple waves of the South African National Income Dynamics Study and the regression discontinuity design, we evaluated the impact of home-based hypertension screening on two-year change in blood pressure. We found that the home-based screening intervention resulted in important reductions in systolic blood pressure for women and younger men. We did not find evidence of an effect on systolic blood pressure for older men or on diastolic blood pressure for either sex. Our results suggest that home-based hypertension screening may be a promising strategy for reducing high blood pressure in low- and middle-income countries, but additional research and policy efforts are needed to ensure that such strategies have maximum reach and impact.


Assuntos
Monitorização Ambulatorial da Pressão Arterial/tendências , Hipertensão/diagnóstico , Programas de Rastreamento , Países em Desenvolvimento , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Fatores Sexuais , África do Sul
10.
Sci Rep ; 9(1): 10970, 2019 07 29.
Artigo em Inglês | MEDLINE | ID: mdl-31358791

RESUMO

The purpose of the present study was to describe the temporal trends in prevalence and management status of hypertension in Korea between 1998 and 2015. Data of adults who were aged 30 years or older were extracted from the Korea National Health and Nutrition Examination Survey, a nationwide representative population-based survey. Hypertension was prevalent in 30.5% of Korean adults. The age and sex standardized prevalence showed little change between 1998 and 2015. The elderly population and men showed higher prevalence. The rates of awareness, treatment, and control showed substantial improvements among hypertensive subjects between 1998 and the time period of 2007‒2009 (awareness, from 23.5 to 66.3%; treatment, from 20.4 to 60.3%; and control, from 4.9 to 42.1%), after which the numbers reached a plateau and no significant changes were observed subsequently (67.3%, 63.6%, and 46.2%, respectively, between 2013 and 2015). The management status remained poor especially among the young population and in men. In conclusion, the hypertension prevalence remained stable at approximately 30% in Korea between 1998 and 2015. While awareness, treatment, and control of hypertension improved remarkably, the young population and particularly men showed a suboptimal management status.


Assuntos
Monitorização Ambulatorial da Pressão Arterial/tendências , Conhecimentos, Atitudes e Prática em Saúde , Hipertensão/epidemiologia , Hipertensão/terapia , Adulto , Fatores Etários , Idoso , Estudos Transversais , Feminino , Inquéritos Epidemiológicos , Humanos , Masculino , Pessoa de Meia-Idade , Inquéritos Nutricionais , Prevalência , República da Coreia/epidemiologia , Fatores de Risco , Fatores Sexuais
11.
J Am Coll Cardiol ; 73(23): 3006-3017, 2019 06 18.
Artigo em Inglês | MEDLINE | ID: mdl-31196459

RESUMO

Three recent renal denervation studies in both drug-naïve and drug-treated hypertensive patients demonstrated a significant reduction of ambulatory blood pressure compared with respective sham control groups. Improved trial design, selection of relevant patient cohorts, and optimized interventional procedures have likely contributed to these positive findings. However, substantial variability in the blood pressure response to renal denervation can still be observed and remains a challenging and important problem. The International Sympathetic Nervous System Summit was convened to bring together experts in both experimental and clinical medicine to discuss the current evidence base, novel developments in our understanding of neural interplay, procedural aspects, monitoring of technical success, and others. Identification of relevant trends in the field and initiation of tailored and combined experimental and clinical research efforts will help to address remaining questions and provide much-needed evidence to guide clinical use of renal denervation for hypertension treatment and other potential indications.


Assuntos
Monitorização Ambulatorial da Pressão Arterial/tendências , Congressos como Assunto/tendências , Hipertensão/cirurgia , Internacionalidade , Rim/inervação , Simpatectomia/tendências , Pressão Sanguínea/fisiologia , Denervação/métodos , Denervação/tendências , Humanos , Hipertensão/diagnóstico , Hipertensão/fisiopatologia , Rim/fisiologia , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Literatura de Revisão como Assunto , Simpatectomia/métodos , Sistema Nervoso Simpático/fisiologia , Sistema Nervoso Simpático/fisiopatologia
13.
J Clin Hypertens (Greenwich) ; 21(5): 566-571, 2019 05.
Artigo em Inglês | MEDLINE | ID: mdl-30980607

RESUMO

Limited information is available regarding the relationship between ambulatory blood pressure monitoring (ABPM) and cardiac geometry in hypertensive children. ABPM and 2D-echocardiography were retrospectively reviewed in children and adolescents <21 years old with primary hypertension. A total of 119 participants (median age 15.0 [IQR 12, 16] years) with hypertension were included. Left ventricular hypertrophy was diagnosed in 39.5% of participants. Normal geometry was found in 47.1%, concentric remodeling (CR) in 13.4%, concentric hypertrophy (CH) in 15.1%, and eccentric hypertrophy (EH) in 24.4% of children. After adjustment for age, sex, and body mass index z-score, awake systolic blood pressure (BP) index (BPi) (OR 1.07, 95% CI: 1.001-1.14, P = 0.045), awake diastolic BPi (OR 1.04, 95% CI: 1.00-1.09, P = 0.048), awake systolic BP load (OR 1.02, 95% CI: 1.000-1.04, P = 0.047), and sleep systolic BP load (OR 1.02, 95% CI: 1.001-1.04, P = 0.03) were directly associated with CH. No ABPM parameters were significant predictors of EH. In conclusion, ABPM parameters were found to be independent predictors of cardiac geometry, specifically CH.


Assuntos
Monitorização Ambulatorial da Pressão Arterial/tendências , Ventrículos do Coração/diagnóstico por imagem , Hipertensão/fisiopatologia , Hipertrofia Ventricular Esquerda/diagnóstico por imagem , Adolescente , Monitorização Ambulatorial da Pressão Arterial/métodos , Índice de Massa Corporal , Estudos de Casos e Controles , Criança , Diástole , Ecocardiografia/métodos , Feminino , Ventrículos do Coração/fisiopatologia , Humanos , Hipertensão/tratamento farmacológico , Hipertensão/etnologia , Hipertrofia Ventricular Esquerda/epidemiologia , Hipertrofia Ventricular Esquerda/fisiopatologia , Masculino , Estudos Retrospectivos , Sístole
14.
Curr Hypertens Rep ; 21(5): 33, 2019 04 05.
Artigo em Inglês | MEDLINE | ID: mdl-30953237

RESUMO

PURPOSE OF REVIEW: This review discusses the recent literature on subjectively and objectively assessed sleep duration in relation to hypertension risk and out-of-clinic blood pressure (BP) measures and highlights critical areas for future research. RECENT FINDINGS: Sleep duration, particularly short sleep, may influence BP through disturbed autonomic balance, hormonal imbalances, increased adiposity and metabolic dysfunction, and disrupted circadian rhythms. Observational studies indicate that short and long sleep are associated with hypertension risk, reduced nocturnal dipping, and elevated morning BP, but evidence is stronger for short sleep. Experimental sleep restriction increases BP, while sleep extension may lower BP in prehypertensive individuals. Women and racial/ethnic minorities are more prone to the detrimental effects of short sleep on BP. Additional studies are warranted to clarify the association of objectively assessed sleep with BP level and diurnal pattern and to determine the sex- and race-specific effects of sleep restriction and extension on BP.


Assuntos
Pressão Sanguínea/fisiologia , Hipertensão/diagnóstico , Transtornos do Sono-Vigília/fisiopatologia , Sono/fisiologia , Pesquisa Biomédica/tendências , Monitorização Ambulatorial da Pressão Arterial/métodos , Monitorização Ambulatorial da Pressão Arterial/tendências , Ritmo Circadiano/fisiologia , Humanos
15.
Pediatrics ; 143(5)2019 05.
Artigo em Inglês | MEDLINE | ID: mdl-31023830

RESUMO

Hypertension affects >40% of the US population and is a major contributor to cardiovascular-related morbidity and mortality. Although less common among children and adolescents, hypertension affects 1% to 5% of all youth. The 2017 Clinical Practice Guideline for the Diagnosis and Management of High Blood Pressure in Children and Adolescents provided updates and strategies regarding the diagnosis and management of hypertension in youth. Despite this important information, many gaps in knowledge remain, such as the etiology, prevalence, and trends of hypertension; the utility and practicality of ambulatory blood pressure monitoring; practical goals for lifestyle modification that are generalizable; the long-term end-organ impacts of hypertension in youth; and the long-term safety and efficacy of antihypertensive therapy in youth. The Eunice Kennedy Shriver National Institute of Child Health and Human Development, in collaboration with the National Heart, Lung, and Blood Institute and the US Food and Drug Administration, sponsored a workshop of experts to discuss the current state of childhood primary hypertension. We highlight the results of that workshop and aim to (1) provide an overview of current practices related to the diagnosis, management, and treatment of primary pediatric hypertension; (2) identify related research gaps; and (3) propose ways to address existing research gaps.


Assuntos
Pesquisa Biomédica/métodos , Hipertensão/diagnóstico , Hipertensão/terapia , National Heart, Lung, and Blood Institute (U.S.) , National Institute of Child Health and Human Development (U.S.) , Adolescente , Pesquisa Biomédica/tendências , Monitorização Ambulatorial da Pressão Arterial/métodos , Monitorização Ambulatorial da Pressão Arterial/tendências , Criança , Pré-Escolar , Educação/métodos , Educação/tendências , Feminino , Humanos , Hipertensão/fisiopatologia , Lactente , Masculino , National Heart, Lung, and Blood Institute (U.S.)/tendências , National Institute of Child Health and Human Development (U.S.)/tendências , Estados Unidos/epidemiologia
19.
J Clin Hypertens (Greenwich) ; 20(7): 1112-1115, 2018 07.
Artigo em Inglês | MEDLINE | ID: mdl-30003696

RESUMO

Ambulatory blood pressure measurement (ABPM) is now recommended in all patients suspected of having hypertension. However, in practice, the mean daytime pressures are often used to make diagnostic and therapeutic decisions, and the information from abnormal patterns of blood pressure behavior is often overlooked. This paper presents daytime patterns (eg, white coat hypertension and siesta dipping), nocturnal patterns (eg, dipping, non-dipping, reverse dipping, and the morning surge), and discusses ambulatory hypotension, and abnormal patterns and indices of related hemodynamic parameters (eg, heart rate, pulse pressure, and blood pressure variability).


Assuntos
Determinação da Pressão Arterial/métodos , Monitorização Ambulatorial da Pressão Arterial/métodos , Ritmo Circadiano/fisiologia , Adulto , Anti-Hipertensivos/uso terapêutico , Pressão Sanguínea/fisiologia , Monitorização Ambulatorial da Pressão Arterial/tendências , Hemodinâmica/fisiologia , Humanos , Hipertensão/diagnóstico , Hipertensão/tratamento farmacológico , Hipertensão/fisiopatologia , Hipotensão/diagnóstico , Pessoa de Meia-Idade , Hipertensão do Jaleco Branco/diagnóstico
20.
Lancet ; 391(10137): 2346-2355, 2018 06 09.
Artigo em Inglês | MEDLINE | ID: mdl-29803589

RESUMO

BACKGROUND: Previous catheter-based renal denervation studies have reported variable efficacy results. We aimed to evaluate safety and blood pressure response after renal denervation or sham control in patients with uncontrolled hypertension on antihypertensive medications with drug adherence testing. METHODS: In this international, randomised, single-blind, sham-control, proof-of-concept trial, patients with uncontrolled hypertension (aged 20-80 years) were enrolled at 25 centres in the USA, Germany, Japan, UK, Australia, Austria, and Greece. Eligible patients had an office systolic blood pressure of between 150 mm Hg and 180 mm Hg and a diastolic blood pressure of 90 mm Hg or higher; a 24 h ambulatory systolic blood pressure of between 140 mm Hg and 170 mm Hg at second screening; and were on one to three antihypertensive drugs with stable doses for at least 6 weeks. Patients underwent renal angiography and were randomly assigned to undergo renal denervation or sham control. Patients, caregivers, and those assessing blood pressure were masked to randomisation assignments. The primary efficacy endpoint was blood pressure change from baseline (measured at screening visit two), based on ambulatory blood pressure measurements assessed at 6 months, as compared between treatment groups. Drug surveillance was used to assess medication adherence. The primary analysis was done in the intention-to-treat population. Safety events were assessed through 6 months as per major adverse events. This trial is registered with ClinicalTrials.gov, number NCT02439775, and follow-up is ongoing. FINDINGS: Between July 22, 2015, and June 14, 2017, 467 patients were screened and enrolled. This analysis presents results for the first 80 patients randomly assigned to renal denervation (n=38) and sham control (n=42). Office and 24 h ambulatory blood pressure decreased significantly from baseline to 6 months in the renal denervation group (mean baseline-adjusted treatment differences in 24 h systolic blood pressure -7·0 mm Hg, 95% CI -12·0 to -2·1; p=0·0059, 24 h diastolic blood pressure -4·3 mm Hg, -7·8 to -0·8; p=0.0174, office systolic blood pressure -6·6 mm Hg, -12·4 to -0·9; p=0·0250, and office diastolic blood pressure -4·2 mm Hg, -7·7 to -0·7; p=0·0190). The change in blood pressure was significantly greater at 6 months in the renal denervation group than the sham-control group for office systolic blood pressure (difference -6·8 mm Hg, 95% CI -12·5 to -1·1; p=0·0205), 24 h systolic blood pressure (difference -7·4 mm Hg, -12·5 to -2·3; p=0·0051), office diastolic blood pressure (difference -3·5 mm Hg, -7·0 to -0·0; p=0·0478), and 24 h diastolic blood pressure (difference -4·1 mm Hg, -7·8 to -0·4; p=0·0292). Evaluation of hourly changes in 24 h systolic blood pressure and diastolic blood pressure showed blood pressure reduction throughout 24 h for the renal denervation group. 3 month blood pressure reductions were not significantly different between groups. Medication adherence was about 60% and varied for individual patients throughout the study. No major adverse events were recorded in either group. INTERPRETATION: Renal denervation in the main renal arteries and branches significantly reduced blood pressure compared with sham control with no major safety events. Incomplete medication adherence was common. FUNDING: Medtronic.


Assuntos
Denervação/métodos , Hipertensão/tratamento farmacológico , Rim/irrigação sanguínea , Artéria Renal/inervação , Angiografia/métodos , Anti-Hipertensivos/uso terapêutico , Pressão Sanguínea/efeitos dos fármacos , Monitorização Ambulatorial da Pressão Arterial/métodos , Monitorização Ambulatorial da Pressão Arterial/tendências , Feminino , Humanos , Hipertensão/cirurgia , Rim/diagnóstico por imagem , Masculino , Adesão à Medicação , Pessoa de Meia-Idade , Artéria Renal/cirurgia , Método Simples-Cego , Resultado do Tratamento
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