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Randomized, controlled, double-blind trial to investigate the effect of colchicin on the endothelial function in patients with CHIP mutations and chronic heart failure with reduced left ventricular function (CHIP-HF)
EU CTIS ID: 2024-518383-12-00
What this study is testing
Efficay and safety of Colchicine in patients with HFrEF and clonal hematopoiesis of indeterminate potential - effects on endothelial cell function, inflammatory biomarkers and inflammatory genetic signatures
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients (m/f) age >/=18
- Ischemic cardiomyopathy with reduced left ventricular function (LVEF </= 40%)
- Stable heart insufficiency (NYHA II-III) under constant (at least 4 weeks) optimal evidence based medical treatment
- Known status of CHIP mutations (DNMT3A and TET2)
- Signed Informed Consent after detailed information
- Negative pregnancy testing, high effective method of contraception (women of child bearing potential)
You likely can't join if
- Acute decompensated heart failure (NYHA IV; HF>110 bpm; systolic blood pressure < 90mmHg
- Known intolerance to Colchicine
- Ejection fraction > LVEF 40%
- Non ischemic etiology of heart failure
- Acute coronary syndromes within three months prior to inclusion
- Invasive procedure within three months prior to inclusion
See the full eligibility criteria
- Patients (m/f) age >/=18
- Ischemic cardiomyopathy with reduced left ventricular function (LVEF </= 40%)
- Stable heart insufficiency (NYHA II-III) under constant (at least 4 weeks) optimal evidence based medical treatment
- Known status of CHIP mutations (DNMT3A and TET2)
- Signed Informed Consent after detailed information
- Negative pregnancy testing, high effective method of contraception (women of child bearing potential)
- Acute decompensated heart failure (NYHA IV; HF>110 bpm; systolic blood pressure < 90mmHg
- Known intolerance to Colchicine
- Ejection fraction > LVEF 40%
- Non ischemic etiology of heart failure
- Acute coronary syndromes within three months prior to inclusion
- Invasive procedure within three months prior to inclusion
- Active malignancy
- Active infection (hs-CRP > 10 mg/dl)
- Liver cirrhosis, CHILD C (ALT < 60 U/l; AST < 60 U/l; Total Bilirubin < 2 mg/dl)
- Renal insufficiency grade 5 (GFR<15 ml/min/1.73m²)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.