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)

2024-518383-12-00 Protocol COL-CHIPHF-P24 Therapeutic exploratory (Phase II) Authorised, recruitment pending

Status Authorised, recruitment pending · 1 EU/EEA countries · 1 sites · Protocol COL-CHIPHF-P24

Overview

Sponsor-declared trial summary

Phase Therapeutic exploratory (Phase II)
Status Authorised, recruitment pending
Participants planned 100
Countries 1
Sites 1

Chronic heart failure

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

Key facts

Sponsor
Goethe University Frankfurt
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Cardiovascular Diseases [C14]
Decision date (initial)
2024-11-05
Transition trial
Yes
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No
Funding sources
Dr. Rolf M. Schwiete Stiftung

External identifiers

EU CT number
2024-518383-12-00
EudraCT number
2021-001508-13

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Therapy

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

Conditions and MedDRA coding

Chronic heart failure

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

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

Exclusion criteria 10

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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. Difference in FMD measurements in HFrEF patients with and without CHIP mutations before and after Colchicin or Placebo treatment

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Colchicin Ysat 0,5 mg Tabletten

PRD6288222 · Product

Active substance
Colchicine
Pharmaceutical form
TABLET
Route of administration
ORAL
Max daily dose
0.50 mg milligram(s)
Max total dose
15 mg milligram(s)
Max treatment duration
30 Day(s)
Authorisation status
Authorised
ATC code
M04AC01 — COLCHICINE
Marketing authorisation
99030.00.00
MA holder
TIOFARMA BV
MA country
Germany
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
Yes
Modification description
Encapsulation of tablet

Placebo 1

Füllstoff DAC in hard gelatine capsules is used as placebo. Füllstoff DAC consists of mannitol 99.5% and colloidal Silicon Dioxide 0.5%

N/A · Product

Other product name
N/A
Pharmaceutical form
N/A
ATC code
N/A — N/A
Marketing authorisation
N/A
MA holder
N/A
MA country
Iceland
Paediatric formulation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Goethe University Frankfurt

14 Total trials 5 Recruiting 7 Ended
Academic / Non-commercial
Sponsor organisation
Goethe University Frankfurt
Address
Theodor-Stern-Kai 7
City
Frankfurt Am Main
Postcode
60590
Country
Germany

Scientific contact point

Organisation
Goethe University Frankfurt
Contact name
Sebastian Cremer

Public contact point

Organisation
Goethe University Frankfurt
Contact name
Sebastian Cremer

Locations

1 EU/EEA country · 1 investigational sites

By country

CountryMS statusPlanned subjectsSites
Germany Authorised, recruitment pending 100 1
Rest of world — 0 —

Investigational sites

Germany

1 site · Authorised, recruitment pending
Goethe University Frankfurt
Cardiology, Theodor-Stern-Kai 7, 60590, Frankfurt Am Main

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 4 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) Studienprotokoll CHIP-HF_v3_08082023 final_blackened 3.0
Recruitment arrangements (for publication) Transition CTIS-Place holder 1
Subject information and informed consent form (for publication) CHIP-HF_Patienteninformation_v3_08082023 final 3.0
Summary of Product Characteristics (SmPC) (for publication) FI Colchicin 05 mg Tbl 1

Application history

1 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-10-10 Germany Acceptable
2024-10-30
 2024-11-05

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