Evaluating the Effect of Coronary Artery Stents on Quality of Life in Heart Failure With Preserved Ejection Fraction and Coronary Artery Disease

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 hearts 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.

Coronary Artery Stents in Heart Failure With Preserved Ejection Fraction