Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-26 @ 3:13 AM
Study NCT ID:
NCT06217120
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-25
First Post:
2023-11-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Reversing Microvascular Dysfunction in Heart Failure With Preserved Ejection Fraction
Sponsor:
Montreal Heart Institute
Organization:
Study Overview
Official Title:
Reversing Microvascular Dysfunction in Heart Failure With Ejection Fraction > 40% Using Colchicine (The COL-Micro-HF Study)
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COL-Micro-HF
Brief 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.
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: