Exercise-based cardiac rehabilitation in patients with heart failure with preserved ejection fraction (HFpEF). Circulatory System Heart failure
Conditions
Interventions
Randomisation will be done via the study web portal and participants will be randomly allocated in a 1:1 ratio to either intervention (REACH-HF plus usual care) or control (usual care only) groups. Us
Sponsors
NHS Greater Glasgow and Clyde
Eligibility
Sex/Gender
All
Age
18 Years to 120 Years
Inclusion criteria
Inclusion criteria: Current participant inclusion criteria as of 03/04/2024: Patients: 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% 4.6. Normal: 55% Patients defined as a ‘normal’ LVEF would therefore meet this inclusion criteria. 5. At least one of the following risk factors: 5.1. Hospital admission in last 3 years for which HF was a major contributor 5.2. N-terminal proBNP >300 pg/ml for patients with sinus rhythm in last 3 years 5.3. N-terminal proBNP >900 pg/ml for patients in atrial fibrillation in last 3 years B-type natriuretic peptide (BNP) and N-terminal prohormone B-type natriuretic peptide (NT-proBNP) levels differ in their values. Guided by the latest ESC 2021 guideline [63] values for BNP and NT-proBNP in the diagnosis of HFpEF and the conversion factor based on these values, the BNP cut offs for the REACH-HFpEF trial are as below: 5.4. 100 pg/ml (If in sinus rhythm) 5.5. 300 pg/ml (if in atrial fibrillation) 6. Informed consent to participate. Caregivers: 1. Women or men aged =18 years 2. Providing unpaid support to patients Cardiac rehabilitation facilitators: 1. Health care professionals facilitating and trained in the REACH-HF intervention delivery. 2. Health care professionals delivering the REACH-HF intervention to participants in the REACH-HFpEF trial. Previous participant inclusion criteria: Patient: 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 (by echocardiography) =45% within 12 months prior to randomisation 5. At least one of the following risk factors: 5.1. Hospital admission in last 12 months for which HF was a major contributor 5.2. N-terminal proBNP >300 pg/ml for patients with sinus rhythm 5.3. N-terminal proBNP >900 pg/ml for patients in atrial fibrillation 6. Informed consent to participate Caregivers: 1. Women or men aged =18 years 2. Providing unpaid support to patients
Exclusion criteria
Exclusion criteria: 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 40 kg/m²; 4. Patients with prior ejection fraction 40 kg/m² 4. Patients with prior ejection fraction <45% 5. eGFR <30 ml/min
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Minnesota Living with Heart Failure Questionnaire (MLWHF) score from baseline to 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Patients: 1. Exercise capacity measured using the Incremental Shuttle Walk Test (ISWT), performed if COVID-19 restrictions permit participants to attend clinic visits, measured at baseline, 4, and 12 months 2. Psychological wellbeing measured using Hospital Depression and Anxiety Scale (HADS) at baseline, 4, and 12 months 3. Level of physical activity measured using accelerometry (GENEActive device) at baseline, 4, and 12 months 4. Generic health-related quality of life measured using the EQ-5D-5L and Short-Form-12 at baseline, 4, and 12 months 5. Self-management measured using the Self-care of Heart Failure Index (SCHFI) & Self-efficacy for key-behaviours questionnaire at baseline, 4, and 12 months 6. Frailty measured using the Clinical Frailty Scale at baseline, 4, and 12 months 7. Prognostic biomarker measured from NT-proBNP at baseline, 4, and 12 months 8. Clinical Events measured by all-cause and heart failure-specific deaths and hospital admissions at baseline, 4, and 12 months 9. Adverse Events and Serious Adverse events recorded at baseline, 4, and 12 months Caregivers: 1. Health-related quality of life measured using EQ-5D-5L and Family Caregiver Quality of Life Scale questionnaire (FAMQoL) at baseline, 4, and 12 months 2. Psychological Wellbeing measured using Hospital Depression and Anxiety Scale (HADS) at baseline, 4, and 12 months 3. Self-management measured using Caregiver Contribution to Self-care of HF Index questionnaire (CC-SCHFI)at baseline, 4, and 12 months 4. Burden measured using Caregiver Burden for HF Questionnaire (CBQ-HF) at baseline, 4, and 12 months | — |
Countries
England, Scotland, United Kingdom, Wales
Contacts
Public ContactEmma Burrell
Outcome results
None listed