Study of Microvascular Dysfunction to Predict Heart Recovery in Idiopathic Dilated Cardiomyopathy Using Coronary Microvascular Assessment and Medical Therapy

What this Trial Is About

Researchers are investigating patients with idiopathic dilated cardiomyopathy and left ventricular dysfunction LVEF 40% who have not yet received anti-remodeling cardiac therapy. The study aims to assess coronary microvascular function using a thermodilution-based invasive method and evaluate how this relates to left ventricular reverse remodeling after 12 months of optimal medical treatment. This prospective, multicenter, single-arm study also seeks to monitor patients for up to 5 years to understand their clinical outcomes better. Participants will undergo coronary angiography to exclude obstructive coronary artery disease and receive fractional flow reserve FFR measurement. Microvascular parameters such as coronary flow reserve CFR, index of microcirculatory resistance IMR, and microvascular resistance reserve MRR will be assessed using a pressurethermodilution guidewire. Hyperemia will be induced by intravenous adenosine or intracoronary papaverine as part of standard care. After baseline assessments, patients will receive optimal medical therapy guided by a heart failure team, with follow-up echocardiography at 12 months to evaluate changes in cardiac remodeling. During the study, participants will have various diagnostic tests including ECG telemetry or Holter monitoring for arrhythmia detection, cardiopulmonary exercise testing for functional capacity, blood tests NT-proBNP, and contrast-enhanced cardiac magnetic resonance imaging CMR, which may be repeated after 12 months. Genetic counseling and testing are recommended per guidelines. The primary outcome is the rate of left ventricular reverse remodeling after one year, with secondary outcomes including adverse cardiac events over five years and functional and imaging changes. The study includes comprehensive monitoring and data collection to understand disease progression and treatment effects.

Microvascular Dysfunction Assessment to Predict Left Ventricular Reverse Remodeling