2024-518383-12-00Not yet recruitingPhase 2
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)
Source: EU CTIS (euclinicaltrials.eu) · Last updated 5 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 10 Oct 2024
- Start date
- 17 Feb 2022
- Lead sponsor
- Goethe University Frankfurt
- Diseases
- Heart failure
- EU CT number
- 2024-518383-12-00
- EudraCT number
- 2021-001508-13
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 100
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with long-term heart failure from a damaged heart muscle after reduced blood flow, with a weak pumping heart, and with known CHIP gene changes (DNMT3A and TET2).
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Ischemic cardiomyopathy with reduced left ventricular function (LVEF 40% or lower). Stable heart failure, NYHA II-III.
- Earlier treatment
- Constant optimal evidence-based medical treatment for at least 4 weeks.
- Biomarker or test result
- Known status of CHIP mutations (DNMT3A and TET2).
Main reasons for not taking part
- Acute decompensated heart failure (NYHA IV)
- Known intolerance to Colchicine
- Heart failure not caused by reduced blood flow to the heart
- Acute coronary syndrome or invasive procedure within three months before joining
- Active cancer or active infection
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Acute coronary syndromes within three months prior to inclusion
- Invasive procedure within three months prior to inclusion
Other illness
- Acute decompensated heart failure (NYHA IV; HF>110 bpm; systolic blood pressure < 90mmHg
- Non ischemic etiology of heart failure
- Active malignancy
Lab values
- Ejection fraction > LVEF 40%
- 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)
Other
- Known intolerance to Colchicine
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Goethe University Frankfurt | Frankfurt Am Main | Germany | Not yet recruiting |
The registry text, word for word
This page is information, not medical advice. Discuss any trial with your doctor.