Clinical trial • Phase II • Cardiology

Colchicine for Chronic heart failure | Heart failure with reduced ejection fraction (HFrEF)

Phase II trial of Colchicine for Chronic heart failure | Heart failure with reduced ejection fraction (HFrEF).

Overview

Trial Therapeutic Area
Cardiology
Trial Disease
Chronic heart failure | Heart failure with reduced ejection fraction (HFrEF)
Trial Stage
Phase II
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
10-10-2024
First CTIS Authorization Date
05-11-2024

Trial design

Randomised, placebo: füllstoff dac in hard gelatine capsules (füllstoff dac consists of mannitol 99.5% and colloidal silicon dioxide 0.5%). active/test product: colchicin ysat 0,5 mg tabletten (colchicine) — oral. dose details: colchicin product lists max daily dose 0.50 mg (see product information); specific dosing schedule not further specified in ctis record.-controlled Phase II trial in Germany.

Randomised
Yes
Comparator
Placebo: Füllstoff DAC in hard gelatine capsules (Füllstoff DAC consists of mannitol 99.5% and colloidal Silicon Dioxide 0.5%). Active/test product: Colchicin Ysat 0,5 mg Tabletten (colchicine) — oral. Dose details: Colchicin product lists max daily dose 0.50 mg (see product information); specific dosing schedule not further specified in CTIS record.
Biomarker Stratified
True, CHIP mutations (biomarker: DNMT3A and TET2); strata: with CHIP mutations vs without CHIP mutations
Target Sample Size
100

Eligibility

Recruits 100 Not a vulnerable population selected. Signed Informed Consent is required from participants (aged >=18) after detailed information. Subject information and informed consent form document available (CHIP-HF_Patienteninformation_v3_08082023). No assent of minors (participants must be >=18)..

Pregnancy Exclusion
Negative pregnancy testing, high effective method of contraception (women of child bearing potential)
Vulnerable Population
Not a vulnerable population selected. Signed Informed Consent is required from participants (aged >=18) after detailed information. Subject information and informed consent form document available (CHIP-HF_Patienteninformation_v3_08082023). No assent of minors (participants must be >=18).

Inclusion criteria

  • {"criterion_text":"- Patients (m/f) age >/=18\n- Ischemic cardiomyopathy with reduced left ventricular function (LVEF </= 40%)\n- Stable heart insufficiency (NYHA II-III) under constant (at least 4 weeks) optimal evidence based medical treatment\n- Known status of CHIP mutations (DNMT3A and TET2)\n- Signed Informed Consent after detailed information\n- Negative pregnancy testing, high effective method of contraception (women of child bearing potential)"}

Exclusion criteria

  • {"criterion_text":"- Acute decompensated heart failure (NYHA IV; HF>110 bpm; systolic blood pressure < 90mmHg\n- Known intolerance to Colchicine\n- Ejection fraction > LVEF 40%\n- Non ischemic etiology of heart failure\n- Acute coronary syndromes within three months prior to inclusion\n- Invasive procedure within three months prior to inclusion\n- Active malignancy\n- Active infection (hs-CRP > 10 mg/dl)\n- Liver cirrhosis, CHILD C (ALT < 60 U/l; AST < 60 U/l; Total Bilirubin < 2 mg/dl)\n- Renal insufficiency grade 5 (GFR<15 ml/min/1.73m²)"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Difference in FMD measurements in HFrEF patients with and without CHIP mutations before and after Colchicin or Placebo treatment","definition_or_measurement_approach":"FMD measurements (flow-mediated dilation) in HFrEF patients with and without CHIP mutations before and after Colchicin or Placebo treatment (comparison of pre- and post-treatment FMD values)."}

Recruitment

Planned Sample Size
100
Recruitment Window Months
48
Consent Approach
Signed informed consent required from participants after detailed information. Subject information and informed consent form document available (CHIP-HF_Patienteninformation_v3_08082023). Participants must be >=18; no assent procedures for minors are indicated.

Geography

Total Number Of Sites
1
Total Number Of Participants
100

Germany

Earliest CTIS Part Ii Submission Date
28-10-2024
Latest Decision Or Authorization Date
05-11-2024
Processing Time Days
8
Number Of Sites
1
Number Of Participants
100

Sites

Site Name
Goethe University Frankfurt
Department Name
Cardiology
Principal Investigator Name
Sebastian Cremer
Principal Investigator Email
cremer@med.uni-frankfurt.de
Contact Person Name
Sebastian Cremer
Contact Person Email
cremer@med.uni-frankfurt.de
Number Of Participants
100

Sponsor

Primary sponsor

Full Name
Goethe University Frankfurt
Organisation Type
Educational Institution
Country Of Registered Address
Germany

Third parties

  • {"country":"","full_name":"Dr. Rolf M. Schwiete Stiftung","duties_or_roles":"Source of monetary support","organisation_type":""}

Investigational products

Investigational Product Name
Colchicin Ysat 0,5 mg Tabletten
Active Substance
Colchicine
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Authorisation Status
Authorised
Starting Dose
0.5 mg (max daily dose listed as 0.50 mg)
Dose Levels
Not specified beyond max daily dose (0.50 mg)
Maximum Dose
Max daily dose 0.50 mg; max total dose amount listed 15 (units per product record)
Investigational Product Name
Füllstoff DAC in hard gelatine capsules is used as placebo. Füllstoff DAC consists of mannitol 99.5% and colloidal Silicon Dioxide 0.5%
Active Substance
Mannitol 99.5% and colloidal Silicon Dioxide 0.5% (excipient/placebo)
Modality
Other
Routes Of Administration
Oral (hard gelatine capsules)
Route
Oral
Authorisation Status
Not authorised/Not applicable

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