NCT06217120

Reversing Microvascular Dysfunction in Heart Failure With Preserved Ejection Fraction

Reversing Microvascular Dysfunction in Heart Failure With Ejection Fraction > 40% Using Colchicine (The COL-Micro-HF Study)

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Montreal Heart Institute · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the impact of colchicine on the change in coronary flow reserve (CFR), a marker for coronary microvascular dysfunction (CMD), compared to placebo in patients with heart failure and ejection fraction above 40% (including patients with improved EF).

Detailed description

This will be a pilot mechanistic study. Patients will be randomly assigned in a 1:1 ratio to receive colchicine 0.5 milligram (mg) daily or a matched placebo. Follow-up will occur six months after randomization. The study aims to test the impact of reducing inflammation using a pharmacological strategy to reverse CMD in patients with HF and EF above 40%. The investigators will test the effect of colchicine on the change in coronary flow reserve (CFR), a marker for CMD, compared to placebo. The investigators will assess CMD using adenosine-based positron emission tomography (PET). The primary objective will be to compare changes in CFR between six months and baseline according to therapy. The primary Endpoint will be the change from baseline to 6 months in CFR, a marker of CMD.

Conditions

• Heart Failure With Preserved Ejection Fraction
• Microvascular Coronary Artery Disease

Interventions

Type	Name	Description
DRUG	Colchicine	Colchicine 0.5 mg daily
DRUG	Placebo	Placebo once daily

Timeline

• Start date: 2024-03-01
• Primary completion: 2025-10-01
• Completion: 2026-03-01
• First posted: 2024-01-22
• Last updated: 2024-01-25

Locations

1 site across 1 country: Canada