Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT07560436

Coronary Artery Stents in Heart Failure With Preserved Ejection Fraction

Led by King's College London · Updated on 2026-05-01

350

Participants Needed

1

Research Sites

175 weeks

Total Duration

On this page

Sponsors

K

King's College London

Lead Sponsor

G

Guy's and St Thomas' NHS Foundation Trust

Collaborating Sponsor

AI-Summary

What this Trial Is About

HFpEF (heart failure with preserved ejection fraction) is a condition in which the heart muscle becomes stiff and can't pump blood properly. People living with HFpEF also often have coronary artery disease, where the blood vessels that supply the heart are narrowed or blocked. It is not yet know whether opening these arteries with stents improves symptoms or quality of life with HFpEF. REPRIEVED is a randomised clinical trial that aims to find out if heart stents can improve quality of life for people living with heart failure with preserved ejection fraction (HFpEF) and coronary artery disease. Researchers will compare two groups of people; those who have a stent procedure to those who have a placebo procedure. The placebo procedure feels the same as a stent procedure but does not include a stent. 350 people with HFpEF and coronary artery disease will be asked to take part. Participants will be monitored over a period of 6 months to see if and how quality of life changes. Before the procedure, participants will be asked to complete a short health questionnaire, have a blood test, undergo an electrocardiogram (heart tracing) and scans of their heart. On the day of the procedure, the participant will come to the hospital for an angiogram and will be randomly allocated to have either treatment with a stent or the placebo procedure without a stent. Participants will not know whether they have received heart stents. This helps researchers know that any improvements in their quality of life are not just related to how they feel about the stenting treatment. Participants will then be contacted by a member of the research team at 3 months and 6 months after their procedure. At 3 months, participants will complete a short health questionnaire either by phone or during a hospital visit. At 6 months, participants will attend the hospital to complete a short health questionnaire, have blood tests, a scan of the heart (echocardiogram) and an electrocardiogram (heart tracing) to measure any changes in the heart. Participants will be told whether they received the stent procedure or the placebo procedure.

CONDITIONS

Official Title

Coronary Artery Stents in Heart Failure With Preserved Ejection Fraction

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of HFpEF based on European Society of Cardiology criteria including symptoms of heart failure (NYHA class II-IV)
  • Left ventricular ejection fraction of 50% or higher
  • NT-pro-BNP over 125 pg/ml in sinus rhythm or over 365 pg/ml in atrial fibrillation
  • At least one objective sign of left ventricular diastolic dysfunction such as elevated left ventricular end diastolic pressure, high pulmonary artery systolic pressure, enlarged left atrial volume, increased left ventricular wall thickness, elevated left ventricular mass index, or high mitral E/E' ratio
  • Adults aged 18 years or older
Not Eligible

You will not qualify if you...

  • Under 18 years of age
  • Unable to provide informed consent
  • Percutaneous coronary intervention (PCI) contraindicated or not feasible based on coronary angiography or CT coronary angiogram
  • Allergy or contraindication to clopidogrel or dual antiplatelet therapy
  • Recent acute myocardial infarction or coronary revascularisation within the past 90 days
  • Participation in another interventional study affecting outcomes
  • Severe chronic obstructive pulmonary disease (GOLD stage 3 or higher)
  • Hemoglobin level 80 g/L or lower
  • Other cardiac diagnosis causing HFpEF such as hypertrophic cardiomyopathy, untreated severe left-sided valvular disease, or cardiac amyloidosis

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Guy's & St Thomas' NHS Foundation Trust

London, United Kingdom

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Coronary Artery Stents in Heart Failure With Preserved Ejection Fraction | DecenTrialz