Heart Rehabilitation for All (HeRTA): Protocol for a feasibility study and pilot randomized trial.

INTRODUCTION: Today, 50% of people with cardiac disease do not participate in rehabilitation. The HeRTA-study aims to develop and test a sustainable rehabilitation model supporting vulnerable patients in participating in rehabilitation and long-term physical activity. METHODS: A feasibility study with a non-blinded pilot randomized trial was developed in collaboration with partners and cardiac patients to test a multi-component rehabilitation intervention across hospital, municipality, and civil society. The study runs from January 2020 to December 2024. Eligibility criteria for participants: a) diagnosed with either ischemic heart disease, persistent atrial fibrillation, heart failure, or have had cardiac valve surgery, b) residents in Hvidovre Hospitals uptake area, c) cognitively functional, d) physically able to participate in rehabilitation. Patient recruitment will be located at Hvidovre Hospital, Capital Region of Denmark, data collection at Hvidovre Hospital, Rehabilitation Center Albertslund, the Danish Heart Association, and in two municipalities (Hvidovre and Brøndby). Patients in the control group have access to usual care at the hospital: rehabilitation-needs-assessment, patient education, and physical training. After or instead of hospital rehabilitation, the patient can be referred to municipal rehabilitation with patient education, and a total of 12 weeks of physical training across sectors. Patients in the intervention group will in addition to usual care, have access to an information book about cardiac disease, patient supporters from the Danish Heart Association, Information materials to inform employers about the employees' rehabilitation participation, a rehabilitation goal setting plan, a support café for relatives, and follow-up phone calls from physiotherapists 1 and 3 months after rehabilitation to support physical activities. Patients with vulnerabilities will additionally receive patient education conducted in small groups, pro-active counselling by a cardiac nurse, psychologist, or social worker, paid transportation to rehabilitation, and paid membership in a sports association. Patients are computer block-randomized so patients with vulnerability are distributed evenly in the two study arms by stratifying on a) a cut-off score of ≥ 5 in the Tilburg Frailty Indicator questionnaire and/or b) need of language translator support. A power calculation, based on an estimated 20% difference in participation proportion between groups, 80% power, a type 1 error of 5% (two-tailed), results in 91 participants in each study arm. The primary outcome: rehabilitation participation (attending ≥ two activities: patient education, smoking cessation, dietary counseling, and physical training) and reaching at least 50% attendance. Secondary outcomes: health-related quality of life, coping strategies, level of physical activities, and sustainability regarding participation in active communities after rehabilitation. The study is registered at ClinicalTrials.gov (NCT05104658). RESULTS: Differences between changes in outcomes between groups will be analyzed according to the intention-to-treat principle. Sensitivity analysis and analysis of the effect of the combined activities will be made. A process evaluation will clarify the implementation of the model, the partnership, and patients' experiences. CONCLUSION: Cross-sectoral collaborations between hospitals, municipalities, and organizations in civil society may lead to sustainable and affordable long-term physical activities for persons with chronic illness. The results can lead to improve cross-sectoral collaborations in other locations and patient groups.

Design and rationale of the Danish trial of beta-blocker treatment after myocardial infarction without reduced ejection fraction: study protocol for a randomized controlled trial.

BACKGROUND: Treatment with beta-blockers is currently recommended after myocardial infarction (MI). The evidence relies on trials conducted decades ago before implementation of revascularization and contemporary medical therapy or in trials enrolling patients with heart failure or reduced left ventricular ejection fraction (LVEF ≤ 40%). Accordingly, the impact of beta-blockers on mortality and morbidity following acute MI in patients without reduced LVEF or heart failure is unclear. METHODS/DESIGN: The Danish trial of beta-blocker treatment after myocardial infarction without reduced ejection fraction (DANBLOCK) is a prospective, randomized, controlled, open-label, non-blinded endpoint clinical trial designed to evaluate the efficacy of beta-blocker treatment in post-MI patients in the absence of reduced LVEF or heart failure. We will randomize 3570 patients will be randomized within 14 days of index MI to beta-blocker or control for a minimum of 2 years. The primary endpoint is a composite of all-cause mortality, recurrent MI, acute decompensated heart failure, unstable angina pectoris, or stroke. The primary composite endpoint will be assessed through locally reported and adjudicated endpoints supplemented by linkage to the Danish national registers. A number of secondary endpoints will be investigated including patient reported outcomes and cardiovascular mortality. Data from similar ongoing trials in Norway and Sweden will be pooled to perform an individual patient data meta-analysis. DISCUSSION: DANBLOCK is a randomized clinical trial investigating the effect of long-term beta-blocker therapy after myocardial infarction in patients without heart failure and reduced LVEF. Results from the trial will add important scientific evidence to inform future clinical guidelines. TRIAL REGISTRATION: Clinicaltrials.gov, NCT03778554. Registered on 19 December 2018. European Clinical Trials Database, 2018-002699-42, registered on 28 September 2018.

The Danish Cardiac Rehabilitation Database.

AIM OF DATABASE: The Danish Cardiac Rehabilitation Database (DHRD) aims to improve the quality of cardiac rehabilitation (CR) to the benefit of patients with coronary heart disease (CHD). STUDY POPULATION: Hospitalized patients with CHD with stenosis on coronary angiography treated with percutaneous coronary intervention, coronary artery bypass grafting, or medication alone. Reporting is mandatory for all hospitals in Denmark delivering CR. The database was initially implemented in 2013 and was fully running from August 14, 2015, thus comprising data at a patient level from the latter date onward. MAIN VARIABLES: Patient-level data are registered by clinicians at the time of entry to CR directly into an online system with simultaneous linkage to other central patient registers. Follow-up data are entered after 6 months. The main variables collected are related to key outcome and performance indicators of CR: referral and adherence, lifestyle, patient-related outcome measures, risk factor control, and medication. Program-level online data are collected every third year. DESCRIPTIVE DATA: Based on administrative data, approximately 14,000 patients with CHD are hospitalized at 35 hospitals annually, with 75% receiving one or more outpatient rehabilitation services by 2015. The database has not yet been running for a full year, which explains the use of approximations. CONCLUSION: The DHRD is an online, national quality improvement database on CR, aimed at patients with CHD. Mandatory registration of data at both patient level as well as program level is done on the database. DHRD aims to systematically monitor the quality of CR over time, in order to improve the quality of CR throughout Denmark to benefit patients.