Rehabilitation enablement in chronic heart failure

Not Applicable

Completed

• Conditions: Heart failure; Circulatory System

• Registration Number: ISRCTN78539530
• Lead Sponsor: Royal Cornwall Hospitals NHS Trust

Brief Summary

2016 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/27798024 protocol 2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/29632081 results (added 29/01/2019) 2021 Other publications in https://pubmed.ncbi.nlm.nih.gov/33407893/ process evaluation (added 12/01/2021) 2023 Other publications in https://pubmed.ncbi.nlm.nih.gov/36759035/ Secondary analysis (added 10/02/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-08-07
• Study Completion: 2016-12-31
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

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

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 (<2 METs, <50 W)
3.13. Uncontrolled diabetes (blood glucose >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

Study & Design

• Study Type: Interventional
• Study Design: Not specified