Colchicine in Patients With Heart Failure and Preserved Left Ventricular Ejection Fraction

NCT05637398 | Completed Phase 1 DMC

• 1 other identifier: 03-22
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 2

Brief Summary

Heart failure with preserved left ventricular ejection fraction (HFpEF) is a syndrome associated with high morbidity and mortality rates. Systemic low-grade inflammation is acknowledged to be a fundamental pathophysiological mechanism of HFpEF. Interventions targeting inflammatory pathway is understudied in HFpEF. Colchicine is a safe and well tolerated anti-inflammatory drug, which interferes with several steps in the inflammatory process. The drug has been extensively studied in different cardiovascular pathologies except HFpEF. We assume that colchicine decreases inflammation and reduces sST2 levels in HFpEF.

Conditions

HFpEF - Heart Failure With Preserved Ejection Fraction; Colchicine

Outcome Measures

Primary Outcomes (2)

• Change in Soluble suppression of tumourigenicity 2 (sST2,ng/ml)

  Delta\_circulating sST2

  from baseline to 12 weeks of treatment

• 2. Change in high-sensitivity C-reactive protein (hsCRP, mg/l )

  Description: Delta\_ circulating hsCRP

  Time Frame: from baseline to 12 weeks of treatment

Secondary Outcomes (9)

• Change in N-terminal pro-brain natriuretic peptide (NTproBNP, ng,ml)

  from baseline to 12 weeks of treatment

• Change in E/e' (average)

  from baseline to 12 weeks of treatment

• Change in Left ventricular global longitudinal strain (LVGLS,%)

  from baseline to 12 weeks of treatment

• Left atrial reservoir strain (LA reservoir strain ,%)

  from baseline to 12 weeks of treatment

• Drug discontinuation

  during 12 weeks of treatment

Study Arms (2)

Colchicine 0.5 bid

ACTIVE COMPARATOR

Eligible HFpEF patients will be randomized in 1:1 ratio by an investigator with either colchicine 0.5 twice daily or usual care for 12 weeks

Drug: Colchicine

Usual Care

NO INTERVENTION

Eligible HFpEF patients will be randomized in 1:1 ratio by an investigator with either colchicine 0.5 twice daily or usual care for 12 weeks

Interventions

Colchicine DRUG

The active treatment intervention consists of colchicine 0.5 mg twice daily that will be administrated by the investigator

Colchicine 0.5 bid

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age, male and female
• Left ventricular ejection fraction (LVEF) ≥ 50%
• Symptoms and signs of heart failure
• N-terminal pro-B-type natriuretic peptide (NT-proBNP) ≥300 pg/ml at baseline (patients in atrial fibrillation at baseline NT-proBNP ≥ 600 pg/ml), left atrial volume index (LAVI) \>34 mL/m2 or a left ventricular mass index (LVMI) =115 g/m2 for males and =95 g/m2 for females
• body mass index (BMI) \> 30kg/m2 or diabetes mellitus

You may not qualify if:

• Hypertrophic cardiomyopathy, constrictive pericarditis, or cardiac amyloidosis
• Acute decompensation of HF in the last 1 month
• Valvular heart disease
• Prior history of LVEF below 50%
• Acute myocardial infarction in the last 3 months, cardiac surgery or cerebrovascular accident within the recent 6 months
• Any active or chronic inflammatory diseases or infections
• Patients with indication for colchicine therapy or history of colchicine intolerance
• Severe hepatic (alanine aminotransferase N3 upper limit of normal or renal dysfunction (estimated glomerular filtration rate \<45 mL/min per 1.73m2)
• Severe nervous system diseases
• History of any malignancy or suffering from cancer
• Lack of informed consent

Sponsors & Collaborators

• I.M. Sechenov First Moscow State Medical University: lead

Study Sites (2)

A Shchendrygina

Moscow, 119415, Russia

Location

Anastasia Shchendrygina

Moscow, 119415, Russia

Location

Related Publications (1)

• Shchendrygina A, Rachina S, Cherkasova N, Suvorov A, Komarova I, Mukhina N, Ananicheva N, Gasanova D, Sitnikova V, Koposova A, Smirnova J, Moiseewa E, Drogashevskaya D. Colchicine in patients with heart failure and preserved left ventricular ejection fraction: rationale and design of a prospective, randomised, open-label, crossover clinical trial. Open Heart. 2023 Aug;10(2):e002360. doi: 10.1136/openhrt-2023-002360.

  PMID: 37586845 DERIVED

MeSH Terms

Interventions

Colchicine

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds

Study Officials

• Anastasia Shchendrygina

  Sechenov Univerity

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All core-laboratory staff will be blind to the endpoints
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2022
• First Posted: December 5, 2022
• Study Start: December 15, 2022
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: April 23, 2026

Record last verified: 2025-09

Locations

RU (2)