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)

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) - CHIP-HF

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-001508-13-DE

Enrollment

100

Registered

2021-05-05

Start date

2021-08-06

Completion date

Unknown

Last updated

2024-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic heart failure with reduced ejection fraction

Interventions

Trade Name: Colchicin Tiofarma 0.5 mg Product Name: Colchicin Tiofarma 0.5 mg Pharmaceutical Form: Tablet INN or Proposed INN: Colchicin CAS Number: 64-86-8 Other descriptive name: Colchicine Concentr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - = 18 years of age - Ischemic cardiomyopathy with reduced ejection fraction LVEF=40% - stable heart failure symptoms (NYHA II/III) on optimal heart failure therapy - know status of CHIP mutations (DNMT3A and TET2) - informed written consent - negative pregnancy test; high effective contraception during the trial (women of childbearing potential) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 80

Exclusion criteria

Exclusion criteria: - Acute decompensated heart failure (NYHA IV; HF>110 bpm; systolic blood pressure 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 > 10mg/dl) -Liver cirrhosis, CHILD C (ALT < 60 U/l; AST < 60 U/l; Total Bilirubin < 2 mg/dl) - known intolerance to Colchicine

Design outcomes

Primary

Measure	Time frame
Main Objective: Efficacy 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;Secondary Objective: Not applicable;Primary end point(s): Difference in FMD measurements in HFrEF patients with and without CHIP mutations before and after Colchicin or Placebo treatment;Timepoint(s) of evaluation of this end point: Screening Baseline Day 30 (Medication stop) Day 60 (End of trial)	—

Measure

Time frame

Main Objective: Efficacy 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;Secondary Objective: Not applicable;Primary end point(s): Difference in FMD measurements in HFrEF patients with and without CHIP mutations before and after Colchicin or Placebo treatment;Timepoint(s) of evaluation of this end point: Screening Baseline Day 30 (Medication stop) Day 60 (End of trial)

—

Secondary

Measure	Time frame
Secondary end point(s): Biomarker - hs-CRP / IL 6 - Proteomics analysis (OLINK assay) - Single Cell Sequencing - flow cytometry (monocytes) Assessment of safety: Gastrointestinal side effects Acute infections requiring hospitalizations;Timepoint(s) of evaluation of this end point: Baseline, Day 30, Day 60 (flow cytometry)	—

Countries

Germany

Contacts

Public ContactStudienzentrum Herzmedizin

Universitätsklinikum Frankfurt Med. Klinik III

maiken.skarke@kgu.de+49696301 85680

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026