Results from the "Me & My Heart" (eMocial) Study: a Randomized Evaluation of a New Smartphone-Based Support Tool to Increase Therapy Adherence of Patients with Acute Coronary Syndrome.

PURPOSE: This study evaluated whether patient support, administered via an electronic device-based app, increased adherence to treatment and lifestyle changes in patients with acute coronary syndrome (ACS) treated with ticagrelor in routine clinical practice. METHODS: Patients (aged ≥ 18 years) with diagnosed ACS treated with ticagrelor co-administered with low-dose acetylsalicylic acid were randomized into an active group (with support tool app for medication intake reminders and motivational messages) and a control group (without support tool app), and observed for 48 weeks (ClinicalTrials.gov Identifier: NCT02615704). Patients were asked to complete the 36-item Short-Form Health Survey (SF-36) and Lifestyle Changes Questionnaire (LSQ), and were assessed for blood pressure and body mass index (BMI) at baseline (visit 1) and at the end of the study (visit 2). Medication adherence was measured using the Brilique Adherence Questionnaire (BAQ). RESULTS: Patients (N = 676) were randomized to an active (n = 342) or a control (n = 334) group. BAQ data were available for 174 patients in the active group and 174 patients in the control group. Over the 48-week period, mean (standard deviation) adherence for the active and control groups was 96.4% (13.2%) and 91.5% (23.1%), respectively (effect of app intervention, p < 0.05). There were no significant differences in blood pressure and BMI between visits. General improvements in SF-36 and LSQ scores were observed for both groups. CONCLUSION: The patient support tool app was associated with significant improvements in patient-reported treatment adherence compared with a data collection app alone in patients prescribed ticagrelor for ACS.

Design and rationale for the "Me & My Heart" (eMocial) study: A randomized evaluation of a new smartphone-based support tool to increase therapy adherence of patients with acute coronary syndrome.

A novel smartphone-based patient support tool was developed to increase the adherence to antiplatelet therapy and lifestyle changes in patients after coronary angioplasty for acute coronary syndrome (ACS). The eMocial study (ClinicalTrials.gov Identifier: NCT02615704) investigates whether an electronic support tool will improve adherence to comedication and lifestyle changes in ACS patients. The primary hypothesis of this trial is that an electronic support tool can increase adherence to comedication (primary endpoint) thereby supporting positive lifestyle changes (secondary endpoints). Patients hospitalized with ACS (ST elevation myocardial infarction [STEMI], non-ST elevation myocardial infarction [NSTEMI], or unstable angina pectoris) and treated with ticagrelor coadministered with low-dose acetylsalicylic acid will be randomized 1:1 to an active group receiving the patient support tool via a smartphone-based application or to a control group without the patient support tool. Patient questionnaires to evaluate lifestyle changes and quality of life will be used at baseline and at the end of the 48-week observation phase. Patients are asked to fill out questionnaires to determine their adherence, treatment attitudes, health-care utilization and risk factors on a monthly basis. The study was started in February 2016 and the completion date is scheduled for October 2019. For final analysis 664 patients are expected be available. Preliminary baseline demographics were unstable angina pectoris (13.7%), NSTEMI (49.9%), STEMI (36.4%), male gender (86.3%), and diabetes mellitus (17.6%). Our study could significantly help to understand how inadequate adherence to antiplatelet therapy in ACS patients could be improved with a smartphone-based application.

Effects of candesartan cilexetil "add-on" treatment in congestive heart failure outpatients in daily practice.

AIMS: In the present study, we investigated the efficacy and safety of candesartan cilexetil (candesartan) as "add-on" treatment in congestive heart failure (CHF) in daily practice. METHODS AND RESULTS: In this open-label, multicenter study 414 CHF outpatients (NYHA II/III) with left ventricular ejection fraction (LVEF) < or = 40% and plasma brain natriuretic peptide (BNP) levels > 200 pg/ml at baseline were enrolled. Patients were treated with standard therapy including at least one angiotensin converting enzyme inhibitor in addition to another CHF drug; 91% of the patients received beta-blockers. Candesartan was uptitrated to 32 mg/day (target dose if tolerated) during 6 weeks followed by constant dosing over 16 weeks. The primary endpoint plasma BNP was significantly reduced by 25% at week 22 (from 394 to 295 pg/ml, P < 0.0001 vs. baseline). Candesartan produced early and sustained improvements of plasma BNP/NT-pro-BNP, LVEF, and quality of life (SF-36) compared to baseline. Of patients on beta-blockers, 37% improved towards NYHA II/I at week 22 (P < 0.0001) and 53.5% of the patients in NYHA III at baseline improved into NYHA II/I at week 22 (n = 232, P < 0.0001). Candesartan was well tolerated; no unexpected findings were reported besides known adverse reactions including hypotension, hyperkalemia, and serum creatinine elevations. CONCLUSION: Candesartan "add-on" treatment provides a good benefit/risk ratio in CHF outpatients in daily practice, although high-risk patients should be managed with frequent monitoring of BP, serum potassium, and renal function.

AFFECT: a prospective, open-label, multicenter trial to evaluate the feasibility and safety of a short-term treatment with subcutaneous certoparin in patients with persistent non-valvular atrial fibrillation.

BACKGROUND: Patients with persistent atrial fibrillation (AF) scheduled for electrical cardioversion need immediate anticoagulation. Unfractionated heparin (UFH) is often used for early anticoagulation in these patients before oral anticoagulation becomes effective. However, dose adjustment is required to achieve a two- to three-fold prolongation of the activated partial thromboplastin. Low molecular weight heparins, given in body weight-adjusted or independent fixed dosage, require less laboratory monitoring and are also effective within hours of first dosing. They seem to be an attractive alternative to UFH. Previous evidence has shown that these drugs are safe and effective in this indication. PATIENTS AND METHODS: In this prospective, open-label, multicenter pilot study, 203 patients were enrolled with persistent non-valvular AF scheduled for electrical cardioversion. Patients received a fixed dose of 8000 U anti-Xa certoparin twice daily starting immediately after enrolment and before cardioversion was performed. Patients with AF > 48 h underwent transoesophageal echocardiography (TEE) before cardioversion to exclude intra-atrial thrombi. After cardioversion, overlapping oral anticoagulation was started. Treatment with certoparin was stopped only after two consecutive days with INR values >2. OBJECTIVES: The objective was to document the feasibility and safety of a short-term treatment with a fixed, body weight-independent certoparin regimen (2 x 8000 U anti-Xa). RESULTS: Out of 203 patients enrolled, 200 received at least one dose of certoparin and were included in the analysis (safety population). Median treatment duration with certoparin was 7 days. Bleedings were observed in 8 patients (4.0%) and were classified as major (1.5%) or minor (2.5%). Cerebral ischemia was reported for 1 patient (0.5%). One patient showed mild thrombocytopenia (0.5%). There were no reports of venous thromboembolism or death during the treatment period. CONCLUSION: Certoparin administered at 8000 U anti-Xa twice daily independent of body weight was safe and appeared to be effective in patients with non-valvular AF undergoing electrical cardioversion. Its ease of use and the possibility of treatment on an outpatient basis make it an attractive option for early anticoagulation in AF.