Heart Failure With Preserved Ejection FractionPhase 2/3COL-Micro-HFNCT06217120
Reversing Microvascular Dysfunction in Heart Failure With Preserved Ejection Fraction
A Phase 2/3 study testing Colchicine in people with Heart Failure With Preserved Ejection Fraction and Microvascular Coronary Artery Disease, run by Montreal Heart Institute at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction, Microvascular Coronary Artery Disease
- What is being tested?
- Colchicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2024to 1 Mar 2026
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects ≥ 40 years of age,
- Chronic symptomatic HF and left ventricular ejection fraction (LVEF) > 40% within 12 months prior to the screening visit (regardless of the imaging modality) documented by one of the following:
- HF requiring hospitalization and IV diuretics within 12 months of study entry, or
- NTproBNP > or = 150pg/ml in sinus rhythm or NTproBNP > or = 450pg/ml in chronic atrial fibrillation,
- New York Heart Association Class, NYHA functional class II to (ambulatory) IV,
- Evidence of pathological systemic inflammation: high C-reactive protein, hs-CRP levels (hs-CRP > or = 5mg/L),
- Subjects with the capacity to provide informed consent.
Who cannot join
- Patients with a diagnosis of infiltrative cardiomyopathy,
- Presence of severe valvular heart disease,
- Presence of active infection within the 3 months prior to enrollment needing antibiotics (excluding COVID (Coronavirus disease)-19),
- Acute decompensated HF, acute coronary syndrome (including MI), cardiac surgery, other major cardiovascular surgery, or urgent percutaneous coronary intervention (PCI) within the 3 months prior to enrollment,
- Known or clinically judged significant (i.e., angina with CCS (Canadian Cardiovascular Society) class > 2/4) epicardial coronary artery disease (CAD) that has not been revascularized (revascularized CAD is defined by a history of myocardial infarction, percutaneous intervention, or coronary artery bypass grafting),
- History of hypersensitivity to colchicine,
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- Evidence of hepatic disease as determined by any 1 of the following: AST or ALT values exceeding 3× the upper limit of normal at enrollment; or patient with a history of cirrhosis, chronic active hepatitis, or severe hepatic disease,
- Patients with estimated glomerular filtration rate (eGFR) <30 ml/min/1.73 m2 as calculated by the Modification in Diet in Renal Disease (MDRD) formula at enrollment,
- Subject with inflammatory bowel disease (Crohn's disease or ulcerative colitis) or patient with chronic diarrhea,
- Patient with pre-existent progressive neuromuscular disease,
- Patient currently taking colchicine for other indications (mainly chronic indications represented by Familial Mediterranean Fever or gout). There is no wash-out period required for patients who have been treated with colchicine and stopped treatment prior to enrolment,
- Patients under long-term steroid medication for a chronic condition,
- Contraindication to dipyridamole-containing medication, acute myocardial infarction or unstable angina in the past 48h,
- Positive pregnancy test results at the screening visit, and females of childbearing potential who do not agree to use adequate methods of contraception for the duration of the study; acceptable means of birth control include: implantable contraceptives, injectable contraceptives, oral contraceptives, transdermal contraceptives, intrauterine devices, male or female condoms with spermicide, abstinence, or a sterile sexual partner,
- History or presence of any other disease with a life expectancy of <1 year,
- Patient considered by the investigator, for any reason, to be an unsuitable candidate for the study.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Montreal Heart Institute
Montreal, Quebec, H1T1C8
Nadia Bouabdallaoui, MD PhD, nadia.bouabdallaoui@icm-mhi.org
About this study
Official title: Reversing Microvascular Dysfunction in Heart Failure With Ejection Fraction > 40% Using Colchicine (The COL-Micro-HF Study)
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).
Read the 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.
- Being tested
- Colchicine, Placebo
- Keywords
- Heart Failure with Preserved Ejection Fraction, Microvascular Coronary Artery Disease, Inflammation, Colchicine
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColchicineDrug
Colchicine 0.5 mg daily
PlaceboDrug
Placebo once daily
| Study group | Role | What they receive |
|---|---|---|
| COLCHICINE | Active comparator | Not described Receives: Drug: Colchicine |
| PLACEBO | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in coronary flow reserve (CFR) between baseline and six months
The primary endpoint will be the change from baseline to 6 months in CFR, a marker of coronary microvascular dysfunction (CMD), according to therapy (colchicine vs. placebo). Assessment of CFR will be based on 82-Rubidium Positron emission tomography (82Rb-PET)-myocardial perfusion imaging, performed at baseline and 6-month follow up.
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start1 Mar 2024 (estimated)
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Preserved Ejection FractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This will be a pilot mechanistic study. Patients will be randomly assigned in a 1:1 ratio to receive colchicine 0.5 mg daily or a matched placebo. Follow-up will occur at 6 months after randomization.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Montreal Heart Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06217120
- Sponsor's protocol ID
- ICM 2024-3370
- Acronym
- COL-Micro-HF
- Status last verified
- Jan 2024
- First submitted
- 29 Nov 2023
- Last updated
- 25 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reversing Microvascular Dysfunction in Heart Failure With Ejection Fraction > 40% Using Colchicine (The COL-Micro-HF Study)
- ClinicalTrials.gov ID
- NCT06217120
- Acronym / sponsor ID
- COL-Micro-HF / ICM 2024-3370
- Keywords
- Heart Failure with Preserved Ejection Fraction, Microvascular Coronary Artery Disease, Inflammation, Colchicine
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Montreal Heart InstituteUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 22 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This will be a pilot mechanistic study. Patients will be randomly assigned in a 1:1 ratio to receive colchicine 0.5 mg daily or a matched placebo. Follow-up will occur at 6 months after randomization.
| Arm | Type | Receives |
|---|---|---|
| COLCHICINE | Active comparator | Drug: Colchicine |
| PLACEBO | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects ≥ 40 years of age,
- Chronic symptomatic HF and left ventricular ejection fraction (LVEF) > 40% within 12 months prior to the screening visit (regardless of the imaging modality) documented by one of the following:
- New York Heart Association Class, NYHA functional class II to (ambulatory) IV,
- Evidence of pathological systemic inflammation: high C-reactive protein, hs-CRP levels (hs-CRP > or = 5mg/L),
- Subjects with the capacity to provide informed consent.
Key exclusion criteria (16 listed)
- Patients with a diagnosis of infiltrative cardiomyopathy,
- Presence of severe valvular heart disease,
- Presence of active infection within the 3 months prior to enrollment needing antibiotics (excluding COVID (Coronavirus disease)-19),
- Acute decompensated HF, acute coronary syndrome (including MI), cardiac surgery, other major cardiovascular surgery, or urgent percutaneous coronary intervention (PCI) within the 3 months prior to enrollment,
- Known or clinically judged significant (i.e., angina with CCS (Canadian Cardiovascular Society) class > 2/4) epicardial coronary artery disease (CAD) that has not been revascularized (revascularized CAD is defined by a history of myocardial infarction, percutaneous intervention, or coronary artery bypass grafting),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ColchicineColchicine 0.5 mg daily | Drug | COLCHICINE |
| PlaceboPlacebo once daily | Drug | PLACEBO |
Primary outcome
Change in coronary flow reserve (CFR) between baseline and six months
Time frame: Baseline and 6 months
The primary endpoint will be the change from baseline to 6 months in CFR, a marker of coronary microvascular dysfunction (CMD), according to therapy (colchicine vs. placebo). Assessment of CFR will be based on 82-Rubidium Positron emission tomography (82Rb-PET)-myocardial perfusion imaging, performed at baseline and 6-month follow up.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2024.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Colchicine in people with Heart Failure With Preserved Ejection Fraction and Microvascular Coronary Artery Disease, run by Montreal Heart Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in coronary flow reserve (CFR) between baseline and six months (time frame: Baseline and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2024.