NCT05637398

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

Recruiting now Phase 1, PHASE2 Last updated 10 April 2025

What this trial tests

Phase 1, PHASE2 trial testing Colchicine in HFpEF - Heart Failure With Preserved Ejection Fraction in 40 participants. Currently enrolling.

Timeline

15 December 2022

Primary endpoint
1 September 2025

1 November 2025

Quick facts

Lead sponsor	I.M. Sechenov First Moscow State Medical University
Phase	Phase 1, PHASE2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	treatment
Enrollment	40
Start date	15 December 2022
Primary completion	1 September 2025
Estimated completion	1 November 2025
Sites	2 locations across Russia

Drugs / interventions tested

• Colchicine (COLCHICINE) — full drug profile →

Conditions studied

• HFpEF - Heart Failure With Preserved Ejection Fraction — all drugs for HFpEF - Heart Failure With Preserved Ejection Fraction →
• Colchicine — all drugs for Colchicine →

Sponsor

I.M. Sechenov First Moscow State Medical University

Who can join

Adults 40 to 80, any sex, with HFpEF - Heart Failure With Preserved Ejection Fraction or Colchicine. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Novel Therapeutics and Upcoming Clinical Trials Targeting Inflammation in Cardiovascular Diseases.
   Potere N, Bonaventura A, Abbate A. · · 2024 · cited 48× · PMID 39387118 · DOI 10.1161/atvbaha.124.319980
2. Aging in Heart Failure: Embracing Biology Over Chronology: JACC Family Series.
   Goyal P, Maurer MS, Roh J. · · 2024 · cited 27× · PMID 38597865 · DOI 10.1016/j.jchf.2024.02.021
3. Left Ventricular Gene Expression in Heart Failure With Preserved Ejection Fraction-Profibrotic and Proinflammatory Pathways and Genes.
   Ye B, Bradshaw AD, Abrahante JE, Dragon JA, et al · · 2023 · cited 20× · PMID 37582166 · DOI 10.1161/circheartfailure.123.010395
4. Circulating neutrophil-related proteins associate with incident heart failure and cardiac dysfunction: The ARIC study.
   Buckley LF, Dorbala P, Claggett BL, Libby P, et al · · 2023 · cited 12× · PMID 37608611 · DOI 10.1002/ejhf.3008
5. A Comprehensive Review: Unraveling the Role of Inflammation in the Etiology of Heart Failure.
   Roman-Pepine D, Serban AM, Capras RD, Cismaru CM, et al · · 2025 · cited 11× · PMID 40360833 · DOI 10.1007/s10741-025-10519-w
6. Colchicine in patients with heart failure and preserved left ventricular ejection fraction: rationale and design of a prospective, randomised, open-label, crossover clinical trial.
   Shchendrygina A, Rachina S, Cherkasova N, Suvorov A, et al · · 2023 · cited 11× · PMID 37586845 · DOI 10.1136/openhrt-2023-002360
7. Current anti-inflammatory strategies for treatment of heart failure: From innate to adaptive immunity.
   Taylor EB, Hall JE, Mouton AJ. · · 2025 · cited 9× · PMID 40348101 · DOI 10.1016/j.phrs.2025.107761
8. Anti-inflammatory pharmacotherapy in patients with cardiovascular disease.
   Finocchiaro S, Mazzone PM, Ammirabile N, Bordonaro C, et al · · 2025 · cited 6× · PMID 40828623 · DOI 10.1093/ehjcvp/pvaf058