Heart failure Circulatory System Heart failure
Conditions
Interventions
1:1 individual participant allocation to either:
1. REACH-HF Manual plus usual care (intervention group) or
2. Usual care alone (control group)
Sponsors
Royal Cornwall Hospitals NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female aged =18 years 2. Patients with heart failure, defined by the presence of at least one of the following symptoms at the time of screening: 2.1. Paroxysmal nocturnal dyspnoea 2.2. Orthopnoea 2.3. Dyspnoea on mild or moderate exertion AND at least one of the following signs prior to study entry: 2.4. Basal crepitations 2.5. Elevated jugular venous pressure 2.6. Lower extremity oedema 2.7. Chest radiograph demonstrating pleural effusion, pulmonary congestion or cardiomegaly 3. Patients with left ventricular ejection fraction (EF) =45% obtained within 6 months prior to randomization and after any myocardial infarction (MI) or other event that would affect EF (ideally obtained by echocardiography, although radionuclide ventriculography and angiography are acceptable) 4. Provision of informed consent to participate.
Exclusion criteria
Exclusion criteria: 1. Patients who have undertaken cardiac rehabilitation (CR) within the last six months 2. Patients with severe chronic pulmonary disease defined as requiring home oxygen or hospitalization for exacerbation within 12 months, or significant chronic pulmonary disease in the opinion of the investigator 3. Patients who have any of the following contraindications to exercise testing or exercise training (adapted from ESC HF guidelines) documented in their medical notes: 3.1. Early phase after acute coronary syndrome (up to 2 days) 3.2. Untreated life-threatening cardiac arrhythmias 3.3. Acute heart failure (during the initial period of haemodynamic instability) 3.4. Uncontrolled hypertension (SBP >200 and/or DBP >100) 3.5. Advanced atrioventricular block 3.6. Acute myocarditis and pericarditis 3.7. Symptomatic aortic stenosis 3.8. Severe hypertrophic obstructive cardiomyopathy 3.9. Acute systemic illness 3.10. Intracardiac thrombus 3.11. Progressive worsening of exercise tolerance or dyspnoea at rest over previous 3–5 days 3.12. Significant ischaemia during low-intensity exercise (16 mmol/l or HbA1C >9% or equivalent unit) 3.14. Recent embolism 3.15. Thrombophlebitis 3.16. Recent-onset atrial fibrillation/atrial flutter (in the last 4 weeks) 4. Patients who are unable to understand the study information or unable to complete study procedures 5. Patients who are in a long-term care establishment or who are unwilling or unable to travel to research assessments or accommodate home visits 6. Patients judged to be unable to participate in the study for any other reason, e.g. psychiatric disorder, diagnosis of dementia, life-threatening co-morbidity 7. Patients participating in concurrent interventional research which may over-burden the patient or confound data collection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Recruitment rate for participants (patients and caregivers) 2. Attrition and loss to follow up at 4 and 6 months 3. Completion and completeness of main trial outcome measures | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Fidelity of HF manual delivery by intervention facilitators 2. Acceptability of the intervention to HFpEF patients, their caregivers and facilitators 3. Acceptability of study participation to participants | — |
Countries
Scotland, United Kingdom
Outcome results
None listed