Ignite Creation Date:
2024-05-06 @ 8:00 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06217120
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-25
First Post:
2023-11-29
Brief Title:
Reversing Microvascular Dysfunction in Heart Failure With Preserved Ejection Fraction
Sponsor:
Montreal Heart Institute
Organization:
Montreal Heart Institute
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 11 ratio to receive colchicine 05 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?:
None