Coronary stents for people with HFpEF and blocked heart arteries
REvascularisation for Heart Failure With PReserved Ejection Fraction and Ischaemia: EValuation of Efficacy and Mechanistic Description
This trial will see if placing coronary artery stents (versus a placebo procedure) helps people with HFpEF and coronary artery disease feel better over six months.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 350 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | King's College London Academic / other |
| Locations | 1 site (London) |
| Trial ID | NCT07560436 on ClinicalTrials.gov |
What this trial studies
REPRIEVED is a phase 2, randomized, placebo-controlled trial enrolling 350 participants with HFpEF and coronary artery disease to test whether percutaneous coronary intervention (PCI) with stent placement improves quality of life. Participants are randomly assigned to receive either a real stent procedure or a placebo (sham) procedure that mimics PCI without placing a stent. Outcomes focus on changes in patient-reported quality of life over a six-month follow-up, with clinical and imaging measures collected per protocol. The trial is led by King's College London with procedures performed at Guy's & St Thomas' NHS Foundation Trust in London.
Who should consider this trial
Good fit: Adults with HFpEF (LVEF ≥50%) who have symptomatic heart failure (NYHA II-IV), elevated natriuretic peptides, objective evidence of diastolic dysfunction, and obstructive coronary artery disease suitable for PCI are the intended candidates.
Not a fit: People without significant obstructive coronary artery disease, those with reduced ejection fraction, or symptoms driven primarily by non-cardiac causes are unlikely to benefit from stenting in this trial.
Why it matters
Potential benefit: If successful, stents could reduce symptoms and improve quality of life for people with HFpEF who have obstructive coronary artery disease.
How similar studies have performed: Sham-controlled PCI trials in stable angina (for example ORBITA) produced mixed results showing placebo effects, and using stents specifically to treat HFpEF is a relatively novel and unproven approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1\. A diagnosis of HFpEF, defined by the European Society of Cardiology (ESC) criteria, defined as: 1. Symptoms of heart failure (New York Heart Association (NYHA) class II-IV) and 2. Left ventricular ejection fraction ≥ 50% and 3. NT-pro-BNP \> 125 pg/ml in sinus rhythm or \> 365 pg/ml in atrial fibrillation and 4. One or more of the following objective signs of left ventricular diastolic dysfunction: i. Invasively measured left ventricular end diastolic pressure ≥ 15 mmHg at rest or ≥ 25 mmHg on exercise (directly measured or estimated via pulmonary capillary wedge pressure) ii. Estimated pulmonary artery systolic pressure \> 35mmHg or tricuspid regurgitation velocity \> 2.8 m/s on echocardiography iii. Left atrial volume index \> 34ml/m2 in patient in sinus rhythm or left atrial volume index \> 40ml/m2 in atrial fibrillation iv. Relative left ventricular wall thickness \> 0.42 v. Left ventricular mass index ≥ 95 g/m2 in females or ≥ 115 g/m2 in males vi. Mitral E/E' ratio \> 9 Exclusion Criteria: 1. Age \<18 years 2. People without capacity to provide informed consent 3. PCI contraindicated or not feasible on coronary angiography or screening CTCA 4. Contraindication to clopidogrel/dual antiplatelet therapy 5. Recent acute myocardial infarction or coronary revascularisation (within 90 days) 6. Enrolment in another interventional study which may affect study outcomes 7. Severe chronic obstructive pulmonary disease (GOLD stage ≥3) 8. Haemoglobin \<=80 g/L 9. Other cardiac diagnosis as a cause for HFpEF (hypertrophic cardiomyopathy, untreated severe left sided valvular disease, cardiac amyloidosis)
Where this trial is running
London
- Guy's & St Thomas' NHS Foundation Trust — London, United Kingdom (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.