HFpEF - Heart Failure With Preserved Ejection FractionPhase 3CO-HFpEFNCT06837623
Role of Colchicine as Anti-Inflammatory Therapy in HFpEF
A Phase 3 study testing Colchicine Tablets in people with HFpEF - Heart Failure With Preserved Ejection Fraction, run by Cairo University at 1 site in Egypt.
Trial summary
Heart failure with preserved ejection fraction (HFpEF) is a condition associated with high morbidity and mortality. Chronic low-grade inflammation plays a key role in its progression, yet few treatments specifically target this pathway. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HFpEF - Heart Failure With Preserved Ejection Fraction
- What is being tested?
- Colchicine Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2024to 1 Mar 2025
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult ≥ 18 years of age, males and females.
- Left Ventricular Ejection Fraction (LVEF) ≥ 50%.
- Symptoms and/or signs of heart failure.
- H2FPEF score ≥ 6 points or HFA-PEFF score ≥ 5 points.
- N-terminal pro-B-type natriuretic peptide (NT-proBNP) ≥125 pg/mL at baseline (patients with atrial fibrillation at baseline NT-proBNP ≥365 pg/mL), or objective evidence of systemic or pulmonary congestion.
- Stable medical therapy within the last 1 month.
Who cannot join
- Patients requiring colchicine for other conditions or with a history of colchicine intolerance or hypersensitivity.
- Active or chronic inflammatory diseases or infection.
- Presence of active solid tumors or hematological malignancies.
- Estimated glomerular filtration rate (eGFR) <35 mL/min/1.73 m².
- Severe liver disease includes Child-Pugh class B or C, cirrhosis, or chronic active hepatitis.
- Concurrent use of strong CYP3A4 or P-glycoprotein inhibitors.
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- Presence of blood dyscrasias.
- Recent major cardiovascular events or procedures within the last 3 months.
- Established diagnosis of pericardial disease, myocarditis, hypertrophic cardiomyopathy, and cardiac amyloidosis
- Significant valvular heart disease.
- Lack of informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Colchicine as Anti-Inflammatory Treatment in Patients With HFpEF: A Prospective Study
Heart failure with preserved ejection fraction (HFpEF) is a condition associated with high morbidity and mortality. Chronic low-grade inflammation plays a key role in its progression, yet few treatments specifically target this pathway.
This clinical trial aims to evaluate the effectiveness of colchicine, a well-tolerated anti-inflammatory drug, in reducing inflammation in HFpEF patients. The study will assess whether colchicine lowers levels of soluble ST2 (sST2), a biomarker linked to inflammation and cardiac stress in HFpEF.
Participants will take colchicine daily for three months, with blood samples collected at baseline and at the end of the study to measure changes in sST2 levels. The findings could provide new insights into the potential role of colchicine as a treatment for HFpEF.
Read the detailed description
Heart failure with preserved ejection fraction (HFpEF) is a complex condition associated with high morbidity and mortality. While its exact causes remain unclear, low-grade systemic inflammation plays a key role by promoting myocardial fibrosis and increasing heart muscle stiffness. Despite this, anti-inflammatory treatments for HFpEF remain largely unexplored.
Colchicine is a well-established anti-inflammatory drug that blocks key inflammatory pathways, including inflammasome activation and the release of interleukin-1 (IL-1). It has demonstrated cardiovascular benefits in trials such as COLCOT and LoDoCo2, significantly reducing the risk of heart-related events in coronary artery disease. However, its effects in HFpEF patients are not yet known.
Two important biomarkers-soluble suppression of tumorigenicity 2 (sST2) and high-sensitivity C-reactive protein (hsCRP)-are strongly linked to worse outcomes in HFpEF. Elevated sST2 reflects increased fibrosis and cardiac stress, while high hsCRP indicates systemic inflammation. Both markers are associated with more severe symptoms and a higher risk of complications. Additionally, the 6-minute walk test (6MWT) is a widely used measure of physical function and exercise capacity in heart failure patients.
This single-center, prospective clinical trial aims to evaluate the effects of colchicine in HFpEF patients with elevated inflammation. Participants will receive colchicine for three months, with assessments of sST2, hsCRP, and 6MWT performance before and after treatment. Findings from this study may provide valuable insights into whether colchicine can reduce inflammation and improve functional capacity in HFpEF patients.
- Being tested
- Colchicine Tablets
- Keywords
- HFpEF, Colchicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colchicine TabletsDrug
Also called Colchicine
Oral colchicine tablets. The dosing regimen is as follows:
- Patients weighing >70 kg: 0.5 mg twice daily (BID)
- Patients weighing ≤70 kg: 0.5 mg once daily (OD) Administered for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Participant Group/Arm | Experimental | Eligible HFpEF patients with a body weight of ≥70 kg will receive colchicine 0.5 mg twice daily, while those weighing <70 kg will receive 0.5 mg once daily, in addition to usual care for 12 weeks. Receives: Drug: Colchicine Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Soluble Suppression of Tumourigenicity 2 (sST2,ng/ml)
Delta_circulating sST2
Measured: From baseline to 12 weeks post-treatment initiation
Secondary outcomes (2)
Change in high-sensitivity C-reactive protein (hsCRP, mg/L)
Delta_circulating_hsCRP
Measured: From baseline to 12 weeks post-treatment initiation
Change in 6 Minute Walk Test (6MWT,meters)
Change in 6MWT distance
Measured: From baseline to 12 weeks post-treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start1 Jul 2024
- Primary completion22 Feb 2025 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HFpEF - Heart Failure With Preserved Ejection FractionStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaima Mohammed Zeyad, Cairo University
- Investigators
- Magdy Abdelhamid Abdel Aziz, Professor of Cardivascular M, Study chair, Cairo UniversityAhmed Kamal, MD in Cardiology, Principal investigator, Cairo UniversityNesrine M El Gharbawi, Prof of clin. & Chem Patho, Principal investigator, Cairo UniversityShaima M Zeyad, Cardiology Resident, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06837623
- Sponsor's protocol ID
- ms-220-2024
- Acronym
- CO-HFpEF
- Status last verified
- Feb 2025
- First submitted
- 15 Feb 2025
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be available upon reasonable request with a corresponding offer.
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Colchicine as Anti-Inflammatory Treatment in Patients With HFpEF: A Prospective Study
- ClinicalTrials.gov ID
- NCT06837623
- Acronym / sponsor ID
- CO-HFpEF / ms-220-2024
- Keywords
- HFpEF, Colchicine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 22 Feb 2025 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 20 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Heart failure with preserved ejection fraction (HFpEF) is a condition associated with high morbidity and mortality. Chronic low-grade inflammation plays a key role in its progression, yet few treatments specifically target this pathway.
This clinical trial aims to evaluate the effectiveness of colchicine, a well-tolerated anti-inflammatory drug, in reducing inflammation in HFpEF patients. The study will assess whether colchicine lowers levels of soluble ST2 (sST2), a biomarker linked to inflammation and cardiac stress in HFpEF.
Participants will take colchicine daily for three months, with blood samples collected at baseline and at the end of the study to measure changes in sST2 levels. The findings could provide new insights into the potential role of colchicine as a treatment for HFpEF.
Detailed description
Heart failure with preserved ejection fraction (HFpEF) is a complex condition associated with high morbidity and mortality. While its exact causes remain unclear, low-grade systemic inflammation plays a key role by promoting myocardial fibrosis and increasing heart muscle stiffness. Despite this, anti-inflammatory treatments for HFpEF remain largely unexplored.
Colchicine is a well-established anti-inflammatory drug that blocks key inflammatory pathways, including inflammasome activation and the release of interleukin-1 (IL-1). It has demonstrated cardiovascular benefits in trials such as COLCOT and LoDoCo2, significantly reducing the risk of heart-related events in coronary artery disease. However, its effects in HFpEF patients are not yet known.
Two important biomarkers-soluble suppression of tumorigenicity 2 (sST2) and high-sensitivity C-reactive protein (hsCRP)-are strongly linked to worse outcomes in HFpEF. Elevated sST2 reflects increased fibrosis and cardiac stress, while high hsCRP indicates systemic inflammation. Both markers are associated with more severe symptoms and a higher risk of complications. Additionally, the 6-minute walk test (6MWT) is a widely used measure of physical function and exercise capacity in heart failure patients.
This single-center, prospective clinical trial aims to evaluate the effects of colchicine in HFpEF patients with elevated inflammation. Participants will receive colchicine for three months, with assessments of sST2, hsCRP, and 6MWT performance before and after treatment. Findings from this study may provide valuable insights into whether colchicine can reduce inflammation and improve functional capacity in HFpEF patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participant Group/Arm | Experimental | Drug: Colchicine TabletsEligible HFpEF patients with a body weight of ≥70 kg will receive colchicine 0.5 mg twice daily, while those weighing <70 kg will receive 0.5 mg once daily, in addition to usual care for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult ≥ 18 years of age, males and females.
- Left Ventricular Ejection Fraction (LVEF) ≥ 50%.
- Symptoms and/or signs of heart failure.
- H2FPEF score ≥ 6 points or HFA-PEFF score ≥ 5 points.
- N-terminal pro-B-type natriuretic peptide (NT-proBNP) ≥125 pg/mL at baseline (patients with atrial fibrillation at baseline NT-proBNP ≥365 pg/mL), or objective evidence of systemic or pulmonary congestion.
Key exclusion criteria (11 listed)
- Patients requiring colchicine for other conditions or with a history of colchicine intolerance or hypersensitivity.
- Active or chronic inflammatory diseases or infection.
- Presence of active solid tumors or hematological malignancies.
- Estimated glomerular filtration rate (eGFR) <35 mL/min/1.73 m².
- Severe liver disease includes Child-Pugh class B or C, cirrhosis, or chronic active hepatitis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colchicine TabletsAlso: ColchicineOral colchicine tablets. The dosing regimen is as follows: * Patients weighing >70 kg: 0.5 mg twice daily (BID) * Patients weighing ≤70 kg: 0.5 mg once daily (OD) Administered for 3 months | Drug | Participant Group/Arm |
Primary outcome
Change in Soluble Suppression of Tumourigenicity 2 (sST2,ng/ml)
Time frame: From baseline to 12 weeks post-treatment initiation
Delta_circulating sST2
2 secondary outcomes
Change in high-sensitivity C-reactive protein (hsCRP, mg/L)
Time frame: From baseline to 12 weeks post-treatment initiation
Change in 6 Minute Walk Test (6MWT,meters)
Time frame: From baseline to 12 weeks post-treatment initiation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- Individual participant dataSharing planned: Undecided. Data will be available upon reasonable request with a corresponding offer.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Magdy Abdelhamid Abdel Aziz, Professor of Cardivascular M study chair
Cairo University
Ahmed Kamal, MD in Cardiology principal investigator
Cairo University
Nesrine M El Gharbawi, Prof of clin. & Chem Patho principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Colchicine Tablets in people with HFpEF - Heart Failure With Preserved Ejection Fraction, run by Cairo University at 1 site in Egypt.
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 6 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: under way, not looking for participants, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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 post-treatment initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Feb 2025.