Actively Recruiting
REvascularisation for Heart Failure With PReserved Ejection Fraction and Ischaemia: Evaluation of Efficacy and Mechanistic Description
Led by King's College London · Updated on 2026-05-01
350
Participants Needed
1
Research Sites
39 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
Heart failure with preserved ejection fraction (HFpEF) is a condition where the heart muscle becomes stiff and struggles to pump blood properly, often alongside coronary artery disease, which narrows or blocks the heart's blood vessels. Researchers are studying whether opening these arteries with stents can improve symptoms and quality of life for people with HFpEF and coronary artery disease. This phase 2 clinical trial randomizes participants to compare the effects of stent treatment versus a placebo procedure. Participants will undergo either a stent procedure called percutaneous coronary intervention (PCI), where narrowed arteries are opened using drug-eluting stents or drug-coated balloon angioplasty, or a placebo procedure that mimics PCI without placing a stent. Both groups receive similar care including clopidogrel capsules for up to 6 months. The procedures will be performed following current best practices, aiming to treat the most significant blockages safely and without staged procedures. Before the procedure, participants complete health questionnaires, blood tests, an electrocardiogram, and heart scans. After the procedure, they will be contacted at 3 months for a questionnaire by phone or hospital visit, and again at 6 months for further questionnaires, blood tests, heart scans, and electrocardiograms to assess heart function and quality of life changes. Participants will be informed whether they received the stent or placebo procedure after the follow-up period. The main outcome measured is quality of life at 6 months using a specific heart failure questionnaire.
CONDITIONS
Brief Title
Coronary Artery Stents in Heart Failure With Preserved Ejection Fraction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosis of HFpEF according to European Society of Cardiology criteria
- Symptoms of heart failure classified as NYHA class II-IV
- Left ventricular ejection fraction of 50% or higher
- Elevated NT-pro-BNP levels (>125 pg/ml in sinus rhythm or >365 pg/ml in atrial fibrillation)
- Presence of one or more signs of left ventricular diastolic dysfunction such as high left ventricular end diastolic pressure, elevated pulmonary artery systolic pressure, enlarged left atrial volume, increased ventricular wall thickness, elevated left ventricular mass index, or high mitral E/E' ratio
You will not qualify if you...
- Under 18 years of age
- Unable to provide informed consent
- Coronary angiography or CTCA shows PCI is contraindicated or not feasible
- Allergy or contraindication to clopidogrel or dual antiplatelet therapy
- Recent acute myocardial infarction or coronary revascularisation within 90 days
- Participation in another interventional study that could affect results
- Severe chronic obstructive pulmonary disease (GOLD stage 3 or higher)
- Hemoglobin level 80 g/L or lower
- Other cardiac conditions causing HFpEF such as hypertrophic cardiomyopathy, severe untreated left-sided valvular disease, or cardiac amyloidosis
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure with medication for up to 6 months
Participants undergo either percutaneous coronary intervention (PCI) with stenting or a placebo PCI procedure. The PCI involves angioplasty and stenting of significant coronary stenoses, while the placebo PCI simulates the procedure without a stent. Participants take matching clopidogrel capsules for up to 6 months after the procedure if assigned the placebo.
1 procedure visit and follow-up visits up to 6 months
Duration - Up to 6 months
Participants are monitored for health status, quality of life, and heart function for up to 6 months after the procedure.
Multiple follow-up visits over 6 months
Trial Site Locations
Total: 1 location
1
Guy's & St Thomas' NHS Foundation Trust
London, United Kingdom
Actively Recruiting
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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