A single-centre randomised controlled pilot trial to assess the feasibility of a definitive trial of the clinical effectiveness and cost effectiveness of the HF Manual in patients with heart failure with preserved ejection fraction and their caregivers (REACH-HFpEF)

Royal Cornwall Hospitals NHS Trust0 sites50 target enrollmentAugust 7, 2015

Overview

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)

Registry

who.int

Start Date

August 7, 2015

End Date

December 31, 2016

Last Updated

3 years ago

Study Type

Interventional

Sex

All

Sponsor

•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

•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