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HFpEF - Heart Failure With Preserved Ejection FractionPhase 1/2NCT05637398

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

A Phase 1/2 study testing Colchicine in people with HFpEF - Heart Failure With Preserved Ejection Fraction and Colchicine, run by I.M. Sechenov First Moscow State Medical University at 2 sites in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 80 years
What is being tested?
Colchicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
2 sitesRussia
Study dates
15 Dec 2022to 1 Sep 2025
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 40 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

Russia2 sites

  • A Shchendrygina

    Moscow, 119415

  • Anastasia Shchendrygina

    Moscow, 119415

Other trials in Russia

About this study

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.

Read the detailed description

HFpEF is a syndrome associated with high morbidity and mortality rates. The underlying mechanisms of the syndrome are not fully understood. Systemic low-grade inflammation is acknowledged to be a fundamental pathophysiological mechanism of HFpEF, which facilitates cardiomyocyte stiffness and myocardial fibrosis development. However, anti-inflammatory treatment approaches are largely under studied. Colchicine is a safe and well tolerated anti-inflammatory drug, which interferes with several steps in the inflammatory process, resulting in suppression of a number of pro-inflammatory pathways and cytokines release, including IL-1, hsCRP. The drug has been extensively studied in patients with coronary artery disease (COLCOT, LoDoCo2) and showed significant reduction in risk of cardio-vascular events, as well as inflammation. Post-hoc analysis of in the CANTOS study investigated the effect of monoclonal antibody targeting interleukin-1β in patients with prior myocardial infarction, showed a reduction in heart failure (HF) hospitalization of patients with elevations in high-sensitivity C-reactive protein (hsCRP). There is no data available regarding the effect of Colchicine on HFpEF patients. Soluble suppression of tumourigenicity 2 (sST2), a member of the interleukin (IL)-1 receptor family, which is not restricted to inflammation, but is also expressed in cardiomyocytes, fibroblast and endothelial cells of cardiac microvessels in response to myocardial stress antagonizing cardioprotective effects of IL-33/ST2 system. In HFpEF, sST2 associated with worse clinical signs and symptoms, co-morbidities, biomarkers of fibrosis and neurohormonal activation. Elevated levels of sST2 are acknowledged as a predictor of worse prognosis in both HF with reduced ejection fraction (HFrEF) and HFpEF. We assume that colchicine decreases inflammation and reduces sST2 levels in HFpEF.

Being tested
Colchicine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ColchicineDrug

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

Study groups in NCT05637398
Study groupRoleWhat they receive
Colchicine 0.5 bidActive comparatorEligible 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
Receives: Drug: Colchicine
Usual CareNo interventionEligible 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

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Delta_circulating sST2

    Measured: from baseline to 12 weeks of treatment

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

    Description: Delta_ circulating hsCRP

    Measured: Time Frame: from baseline to 12 weeks of treatment

Secondary outcomes (9)

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

    Delta_circulating NTproBNP

    Measured: from baseline to 12 weeks of treatment

  2. Change in E/e' (average)

    Delta_ E/e' (average) by 2D- echocardiography

    Measured: from baseline to 12 weeks of treatment

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

    Delta_ left ventricular global longitudinal strain by 2D speckle tracking-echocardiography

    Measured: from baseline to 12 weeks of treatment

  4. Left atrial reservoir strain (LA reservoir strain ,%)

    Delta_ LA reservoir strain by 2D speckle tracking-echocardiography

    Measured: from baseline to 12 weeks of treatment

  5. Drug discontinuation

    Frequency of drug discontinuation

    Measured: during 12 weeks of treatment

  6. Incidence of side effects

    Side effects will be registered and include gastrointestinal symptoms, hepatotoxicity, muscle weakness or pain, myotoxicity, renal dysfunction

    Measured: during 12 weeks of treatment

  7. Change in insulin-like growth factor-binding protein 7 (IGFBP-7, ng/ml)

    Delta_circulating IGFBP-7

    Measured: from baseline to 12 weeks of treatment

  8. Change in procollagen type I carboxy-terminal propeptide (PICP, ng/ml)

    Delta_circulating PICP

    Measured: from baseline to 12 weeks of treatment

  9. Change in C-terminal telopeptide of collagen type I (CITP,ng/ml)

    Delta_circulating CITP

    Measured: from baseline to 12 weeks of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Dec 2022
  2. Study start15 Dec 2022
  3. Primary completion1 Sep 2025
  4. Study completion1 Sep 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05637398
Sponsor's protocol ID
03-22
Status last verified
Sep 2025
First submitted
5 Nov 2022
Last updated
23 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 37586845

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Colchicine in people with HFpEF - Heart Failure With Preserved Ejection Fraction and Colchicine, run by I.M. Sechenov First Moscow State Medical University at 2 sites in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Soluble suppression of tumourigenicity 2 (sST2,ng/ml) (time frame: from baseline to 12 weeks of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05637398, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.

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