Coronary Artery Stents in Heart Failure With Preserved Ejection Fraction

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorKing's College London

About this trial

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.

Eligibility criteria

Qualifiers

Symptoms of heart failure (New York Heart Association (NYHA) class II-IV) and

Left ventricular ejection fraction ≥ 50% and

NT-pro-BNP > 125 pg/ml in sinus rhythm or > 365 pg/ml in atrial fibrillation and

Disqualifiers

Age <18 years

People without capacity to provide informed consent

PCI contraindicated or not feasible on coronary angiography or screening CTCA

Contraindication to clopidogrel/dual antiplatelet therapy

Trial design

Treatments tested in this trial

  • Percutaneous coronary intervention
  • Placebo procedure

Treatment groups

350 Participants
are divided into 2 treatment groups

Sponsors and collaborators

King's College London

Lead sponsor

Guy's and St Thomas' NHS Foundation Trust

Collaborator