Randomised controlled trial of a facilitated home-based rehabilitation intervention in patients with heart failure with preserved ejection fraction and their caregivers: The REACH-HFpEF Trial

HS Greater Glasgow and Clyde0 sites520 target enrollmentJuly 26, 2021

Overview

No summary available.

Registry

who.int

Start Date

July 26, 2021

End Date

November 30, 2026

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

HS Greater Glasgow and Clyde

•Current participant inclusion criteria as of 03/04/2024:
•1\. Women or men aged \=18 years
•2\. Currently symptomatic HF (NYHA Class II\-IV)
•3\. Prescribed loop diuretics and the need for intermittent loop diuretics for the management of symptoms or signs of congestion
•4\. Left ventricular ejection fraction (LVEF) (within 3 years by echocardiography or MRI) \=45% prior to randomisation. If Simpsons LVEF is missing, please use the qualitative eyeball assessment and assign a quantitative value as previously described for the BIOSTAT\-CHF validation cohort \[62]:
•4\.1\. Severe: 25%
•4\.2\. Moderate to severe: 30%
•4\.3\. Moderate: 35%
•4\.4\. Mild to moderate: 40%
•4\.5\. Mild: 44%

•Current participant exclusion criteria as of 03/04/2024:
•1\. Patients who have undertaken CR within the last 12 months
•2\. Patients who have any contraindications to exercise training (according to local cardiac rehabilitation guidelines)
•3\. Probable alternative diagnoses that in the opinion of the investigator could account for the patient’s HF symptoms (i.e. dyspneoa, fatigue), such as significant pulmonary disease (including primary pulmonary hypertension), anaemia, or obesity. Specifically, patients with the following should be excluded:
•3\.1\. Severe pulmonary disease including COPD (i.e. requiring home oxygen, chronic nebulizer therapy, or chronic oral steroid therapy or hospitalised for pulmonary decompensation within 12 months)
•3\.2\. Haemoglobin \<10 g/dll
•3\.3\. BMI \>40 kg/m²;
•4\. Patients with prior ejection fraction \<45%.
•5\. Patients located in a long\-term care home/support setting who are considered to be too frail to engage with the intervention or who are unwilling to travel to research assessments or accommodate home visits.
•6\. Patients who are unable to understand the study information or unable to complete the outcome questionnaires.