Heart failure with preserved ejection fraction (HFpEF) and coronary artery disease Circulatory System
Conditions
Interventions
Patients with HFpEF and coronary artery disease will be randomised 1:1 using an online randomisation system to either PCI (intervention group) or placebo procedure (control group) using an online rand
Sponsors
King's College London
Guy's & St Thomas' NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. A diagnosis of HFpEF, defined by the European Society of Cardiology (ESC) criteria, as: 1.1. Symptoms of heart failure (New York Heart Association (NYHA) class II-IV) and 1.2. Left ventricular ejection fraction >=50% and 1.3. One or more of the following objective signs of left ventricular diastolic dysfunction: 1.3.1. 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) 1.3.2. Estimated pulmonary artery systolic pressure > 35mmHg or tricuspid regurgitation velocity >2.8 m/s on echocardiography 1.3.3. Left atrial volume index >34ml/m2 in patient in sinus rhythm or left atrial volume index >40 ml/m2 in atrial fibrillation 1.3.4. Relative left ventricular wall thickness >0.42 1.3.5. Left ventricular mass index >=95 g/m2 in females or >=115 g/m2 in males 1.3.6. Mitral E/E’ ratio > 9 and 1.4. NT-pro-BNP >125 pg/ml in sinus rhythm or >365 pg/ml in atrial fibrillation plus 2. Significant coronary artery disease defined as: 2.1. Functionally significant disease in at least one major proximal epicardial coronary artery (British Cardiovascular Intervention Society Jeopardy Score >=4) with a fractional flow reserve (FFR) <=0.80 measured with FFR, estimated with computational fluid dynamics during invasive angiography (e.g. VFR) or CT-FFR.
Exclusion criteria
Exclusion criteria: 1. Age =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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary efficacy: Quality of life measured using KCCQ-OSS at 6 months Primary mechanistic: CFR measured using pressure wire at 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes: 1. All-cause death and hospitalisation for heart failure at 6 months 2. Efficacy of blinding assessed using standard tools at discharge 3. ICHOM standard outcome set for heart failure at 6 months 4. Individual components of the KCCQ (including total symptom score and clinical summary score) at 6 months 5. Health status measured using New York Heart Association (NYHA) functional class at 6 months 6. NT-pro-BNP measured using blood test/assay at 6 months 7. Difference in left ventricular ejection fraction (LVEF) and diastolic function (mitral E/e’) measured at 6 months Secondary mechanistic: Change in invasively measured fractional flow reserve (FFR), CFR and microvascular resistance from pre- to post-PCI in all target coronary arteries measured during the PCI procedure | — |
Countries
England, Scotland, United Kingdom
Contacts
Public ContactMatthew Kwok
Outcome results
None listed