ABSTRACT
OBJETIVO: Se describen los datos basales de clase y capacidad funcional, comorbilidades, calidad de vida y cambios en la medicación durante la optimización del tratamiento, en pacientes con insuficiencia cardiaca y función sistólica deprimida (ICFSD) incluidos en el estudio EFICAR. DISEÑO: Ensayo clínico aleatorizado multicéntrico. EMPLAZAMIENTO: Siete Centros de Salud. PARTICIPANTES: Ciento cincuenta pacientes con ICFSD; edad 68 ± 10 años, 77% varones. Mediciones: Variables sociodemográficas e índice de Charlson. Se evaluó la calidad de vida y la capacidad funcional Se realizó optimización del tratamiento. RESULTADOS: La etiología principal fue la cardiopatía isquémica (45%). Índice de Charlson global: 2,03 ± 1,05. El 31% ingresaron durante el último año por insuficiencia cardiaca. Fracción de eyección media: 37% ± 8. Clase funcional ii: 89%. Capacidad funcional con prueba de esfuerzo: 6,3 ± 1,6. Test 6 min: 446 ± 78 m. Test de la silla: 13,7 ± 4,4 s. Dinamómetro: 34,53 ± 10,12 kgf y 0,58 ± 0,16 bar. Short Form-36 Health Survey: salud física: 43,3 ± 8,4; salud mental: 50,1 ± 10,6. Minnesota Living with Heart Failure Questionnaire global: 22,8 ± 18,7. Tras optimizar el tratamiento no varió el porcentaje de pacientes ni la dosis media de fármacos analizados. CONCLUSIONES: La mayoría de los sujetos están en clase funcional ii, con capacidad funcional y calidad de vida disminuida e índice de comorbilidad elevado. Un ajuste protocolizado del tratamiento no consigue aumentar la dosis ni el número de pacientes con fármacos eficaces para la insuficiencia cardiaca con función cardiaca deprimida
OBJECTIVES: To describe the baseline date and drugs therapy changes during treatment optimization in patients with heart failure with depressed systolic function included in the EFICAR study. DESIGN: Multicenter randomized clinical trial. LOCATION: Seven Health Centers. PARTICIPANTS: 150 patients (ICFSD) age 68 ± 10 years, 77% male. MEASUREMENTS: Sociodemographic variables, comorbidities (Charlson index), functional capacity and quality of life. Drug therapy optimization was performed. RESULTS: The main etiology was ischemic heart disease (45%), with 89% in functional class ii. The Charlson index was 2.03 ± 1.05. The ejection fraction mean was 37% ± 8, 19% with ejection fraction < 30%. With the stress test 6.3 ± 1.6 mean was reached, with the 6 minutes test 446 ± 78 meters and the chair test 13.7 ± 4.4 seconds. The overall quality of life with ejection fraction was 22.8 ± 18.7 and with the Short Form-36 Health Survey, physical health 43.3 ± 8.4 and mental health 50.1 ± 10.6. After optimizing the treatment, the percentage of patients on drugs therapy and the dose of angiotensin converting enzyme inhibitors, angiotensin II receptor antagonists and beta-blockers were not changed. CONCLUSIONS: The majority of the subjects are in functional class ii, with functional capacity and quality of life decreased and comorbidity index high. A protocolized drug therapy adjustment did not increase the dose or number of patients with effective drugs for heart failure with depressed systolic function
Subject(s)
Humans , Male , Female , Aged , Aged, 80 and over , Heart Failure/epidemiology , Heart Failure/pathology , Heart Failure/etiology , Primary Health Care/methods , Primary Health Care , Medication Therapy Management , Indicators of Morbidity and Mortality , Pharmaceutical Preparations , Comorbidity , Quality of Life , Myocardial Ischemia/prevention & control , Myocardial Ischemia/therapy , Multicenter Studies as Topic/methods , Multicenter Studies as Topic , Randomized Controlled Trials as Topic/methods , Randomized Controlled Trials as Topic , Surveys and QuestionnairesABSTRACT
OBJECTIVES: To describe the baseline date and drugs therapy changes during treatment optimization in patients with heart failure with depressed systolic function included in the EFICAR study. DESIGN: Multicenter randomized clinical trial. LOCATION: Seven Health Centers. PARTICIPANTS: 150 patients (ICFSD) age 68±10 years, 77% male. MEASUREMENTS: Sociodemographic variables, comorbidities (Charlson index), functional capacity and quality of life. Drug therapy optimization was performed. RESULTS: The main etiology was ischemic heart disease (45%), with 89% in functional class II. The Charlson index was 2.03±1.05. The ejection fraction mean was 37%±8, 19% with ejection fraction <30%. With the stress test 6.3±1.6 mean was reached, with the 6 minutes test 446±78 meters and the chair test 13.7±4.4 seconds. The overall quality of life with ejection fraction was 22.8±18.7 and with the Short Form-36 Health Survey, physical health 43.3±8.4 and mental health 50.1±10.6. After optimizing the treatment, the percentage of patients on drugs therapy and the dose of angiotensin converting enzyme inhibitors, angiotensin II receptor antagonists and beta-blockers were not changed. CONCLUSIONS: The majority of the subjects are in functional class II, with functional capacity and quality of life decreased and comorbidity index high. A protocolized drug therapy adjustment did not increase the dose or number of patients with effective drugs for heart failure with depressed systolic function.
Subject(s)
Adrenergic beta-Antagonists/therapeutic use , Angiotensin-Converting Enzyme Inhibitors/therapeutic use , Heart Failure/drug therapy , Aged , Comorbidity , Drug Therapy, Combination , Female , Health Status , Humans , Male , Middle Aged , Quality of LifeABSTRACT
BACKGROUND: Functional capacity is a prognostic factor for coronary patients; accordingly, they are recommended to walk. OBJECTIVE: To assess whether an exercise program supervised in primary care increases their functional capacity more than unsupervised walking. METHODS: A randomized clinical trial was carried out at eight primary care centres of the Spanish Health Service and involving 97 incident cases of low-risk acute coronary patients, <80 years old, randomly assigned to either an unsupervised walking program (UW group; n = 51) or a 6-month cycle ergometer exercise program with gradually increasing frequency and workload intensity supervised by primary care nurses (SE group; n = 46). The two groups received the same common components of secondary prevention care. Changes in functional capacity were assessed in terms of peak oxygen consumption (VO2peak) during exercise testing measured at baseline and at 7 months by cardiologists blinded to group assignment. RESULTS: Overall, 76% of participants completed the study, 30 in the SE and 44 in the UW. Both groups increased baseline-adjusted VO2peak: 5.56ml/kg per minute in the SE (95% confidence interval [CI] 3.38-7.74) and 1.64ml/kg per minute in the UW (95% CI -0.15 to 3.45). The multivariate-adjusted difference between groups was 4.30ml/kg per minute (95% CI 1.82-6.79; P = 0.001) when analyzing completers and 2.83ml/kg per minute (95% CI 0.61-5.05; P = 0.01) in the intention-to-treat analysis, including all participants with baseline values carried forward for those lost to follow-up. CONCLUSIONS: A cycle ergometer exercise program supervised by primary care nurses increased the functional capacity of coronary patients more than unsupervised walking with a clinically relevant difference.
Subject(s)
Angina, Stable/rehabilitation , Coronary Disease/rehabilitation , Exercise Therapy/methods , Myocardial Infarction/rehabilitation , Myocardial Revascularization/rehabilitation , Oxygen Consumption , Primary Health Care/methods , Walking , Adult , Aged , Angioplasty, Balloon, Coronary/rehabilitation , Coronary Angiography , Coronary Artery Bypass/rehabilitation , Coronary Disease/diagnostic imaging , Exercise Test , Female , Humans , Male , Middle Aged , Prognosis , Treatment OutcomeABSTRACT
BACKGROUND: Quality of life (QoL) decreases as heart failure worsens, which is one of the greatest worries of these patients. Physical exercise has been shown to be safe for people with heart failure. Previous studies have tested heterogeneous exercise programs using different QoL instruments and reported inconsistent effects on QoL. The aim of this study is to evaluate the effectiveness of a new exercise program for people with heart failure (EFICAR), additional to the recommended optimal treatment in primary care, to improve QoL, functional capacity and control of cardiovascular risk factors. METHODS/DESIGN: Multicenter clinical trial in which 600 patients with heart failure in NYHA class II-IV will be randomized to two parallel groups: EFICAR and control. After being recruited, through the reference cardiology services, in six health centres from the Spanish Primary Care Prevention and Health Promotion Research Network (redIAPP), patients are followed for 1 year after the beginning of the intervention. Both groups receive the optimized treatment according to the European Society of Cardiology guidelines. In addition, the EFICAR group performs a 3 month supervised progressive exercise program with an aerobic (high-intensity intervals) and a strength component; and the programme continues linked with community resources for 9 months. The main outcome measure is the change in health-related QoL measured by the SF-36 and the Minnesota Living with Heart Failure Questionnaires at baseline, 3, 6 and 12 months. Secondary outcomes considered are changes in functional capacity measured by the 6-Minute Walking Test, cardiac structure (B-type natriuretic peptides), muscle strength and body composition. Both groups will be compared on an intention to treat basis, using multi-level longitudinal mixed models. Sex, age, social class, co-morbidity and cardiovascular risk factors will be considered as potential confounding and predictor variables. DISCUSSION: A key challenges of this study is to guarantee the safety of the patients; however, the current scientific evidence supports the notion of there being no increase in the risk of decompensation, cardiac events, hospitalizations and deaths associated with exercise, but rather the opposite. Safety assurance will be based on an optimized standardised pharmacological therapy and health education for all the participants. TRIAL REGISTRATION: Clinical Trials.gov Identifier: NCT01033591.
