Coronary stents for people with HFpEF and blocked heart arteries

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Guy's & St Thomas' NHS Foundation Trust
  London, United Kingdom Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.