Coronary Artery Stents in Heart Failure With Preserved Ejection Fraction

Official title

REvascularisation for Heart Failure With PReserved Ejection Fraction and Ischaemia: EValuation of Efficacy and Mechanistic Description

Overview

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.

Interventions

• Procedure Percutaneous coronary intervention
  Participants will receive percutaneous coronary intervention (PCI) as per current standard of care. Angioplasty and stenting will be attempted to all significant coronary stenoses as determined by the CT-FFR or FFR measurements. Contemporary best practice including the use of intracoronary imaging is mandated. The default approach will be to implant drug eluting stents, but drug coated balloon angioplasty is permitted in selected cases in accordance with the current evidence base and guidelines.
• Other Placebo procedure
  Participant will undergo a placebo PCI procedure that involves placement of a thin tube to image the blood vessel but does not involve placement of an actual stent. Movements of the image intensifier, screen display and personnel will simulate a PCI procedure.

Primary outcome measures

• Quality of life measured using KCCQ-OSS [Time frame: At 6 months]

Secondary outcome measures (7)

• All-cause death and hospitalisation for heart failure [Time frame: At 6 months]
• Efficacy of blinding assessed using the blinding index [Time frame: At discharge from the procedure]
• Individual components of the KCCQ (including total symptom score and clinical summary score) [Time frame: At 6 months]
• Health status measured using New York Heart Association (NYHA) functional class [Time frame: At 6 months]
• NT-pro-BNP measured using blood test/assay [Time frame: At 6 months]
• Difference in left ventricular ejection fraction (LVEF) [Time frame: At 6 months]
• Difference in diastolic function (mitral E/e') [Time frame: At 6 months]

Eligibility criteria

Inclusion criteria

1\. A diagnosis of HFpEF, defined by the European Society of Cardiology (ESC) criteria, defined as:

• 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
• 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

• 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
• Recent acute myocardial infarction or coronary revascularisation (within 90 days)
• Enrolment in another interventional study which may affect study outcomes
• Severe chronic obstructive pulmonary disease (GOLD stage ≥3)
• Haemoglobin <=80 g/L
• Other cardiac diagnosis as a cause for HFpEF (hypertrophic cardiomyopathy, untreated severe left sided valvular disease, cardiac amyloidosis)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

United Kingdom · 1 center

• Guy's & St Thomas' NHS Foundation Trust — London

Identifiers

NCT: NCT07560436 · IRAS ID 330189 · NIHR159715 · 12843546

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗