Heart Failure With Preserved Ejection FractionPhase 2NCT06081049
The COLchicine HEART Failure PRESERVED Trial (COLHEART-PRESERVED)
A Phase 2 study testing Colchicine in people with Heart Failure With Preserved Ejection Fraction, run by Tor Biering-Sørensen at 1 site in Denmark.
Trial summary
The purpose of this study is to investigate the effects of colchicine on heart failure related health status, quality of life, and vascular and cardiac function in patients with heart failure with preserved ejection fraction (HFpEF). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction
- What is being tested?
- Colchicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 152 participants
- Where
- 1 siteDenmark
- Study dates
- 18 Jan 2024to Jun 2026
- Phase
- Phase 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- LVEF ≥ 45% judged by echocardiography during the screening epoch or within 6 months prior to screening visit
- Symptom(s) of heart failure for at least 30 days prior to screening visit and current symptoms of heart failure (NYHA functional class II-IV) at screening visit
- Objective evidence of cardiac structural and/or functional abnormalities consistent with the presence of LV diastolic dysfunction/raised LV filling pressures (left atrial enlargement and/or left ventricular hypertrophy) judged by echocardiography at screening epoch or within 12 months prior to screening visit
- Raised pro-BNP ≥ 125 pg/ml (sinus rhythm) or ≥ 300 pg/ml (atrial fibrillation (AF)).
- Body Mass Index (BMI) < 40 kg/m2 at screening visit
- Female patients should either not be of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile, or of childbearing potential and practicing one of the following methods of contraception throughout the study and for 30 days after study completion: Hormonal contraception (oral contraceptives, contraceptive implant, injectable birth control, contraceptive patch, or vaginal ring) or intrauterine device
- Patients will have given written, informed consent and are able and willing to comply with the requirements of the study protocol
Who cannot join
- Colchicine treatment for another cause, e.g., gout
- Allergy/hypersensitivity to colchicine
- Uncontrolled hypertension (systolic BP >180 mmHg or diastolic BP >110 mmHg)
- History of malignancy of any organ system excluding a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma, localized prostate cancer and/or localized carcinoma in situ of the cervix
- Cirrhosis, chronic active hepatitis, or other severe hepatic disease
- Hemodialysis
Show all 30Show fewer
- Estimated glomerular filtration rate (eGFR) < 35 mL/min/1.73 m2
- Systemic treatment with moderate or strong cytochrome P450 3A4 (CYP3A4) inhibitors or P-glycoprotein inhibitors
- Anemia, thrombocytopenia, or leucopenia defined as any of the following measurements within the last 3 months:
- Hemoglobin < 7 mmol/L
- Platelet count < 110 x 109/L
- White blood cell count < 3.0 x 109/L
- Acute decompensated heart failure (hospitalization for heart failure within 7 days prior to screening visit)
- Acute coronary syndrome (including MI), cardiac surgery, other major cardiovascular surgery, ablation of atrial flutter/fibrillation, valve repair/replacement, implanted cardioverter defibrillator or urgent PCI within 3 months prior to screening visit or an elective PCI within 30 days prior to screening visit
- Planned coronary revascularization (percutaneous intervention or surgical), major cardiac surgery (coronary artery bypass grafting, valve repair/replacement, ventricular assist device, cardiac transplantation, or any other surgery requiring thoracotomy), CRT or ablation of atrial flutter/fibrillation during the trial
- Any clinical event within 6 months prior to screening visit that could have reduced LVEF (e.g., MI, CABG), unless echocardiographic measurement was performed after the event confirming LVEF ≥ 45%
- Stroke, transient ischemic attack, carotid surgery, or carotid angioplasty within 3 months prior to screening visit
- Previous cardiac transplantation, complex congenital heart disease or cardiac resynchronization therapy
- Heart failure due to any of the following: known infiltrative cardiomyopathy, active myocarditis, constrictive pericarditis, cardiac tamponade, known genetic hypertrophic cardiomyopathy, obstructive cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy or uncorrected severe/hemodynamically significant valvular heart disease
- Life threatening or uncontrolled dysrhythmia, including symptomatic or sustained ventricular tachycardia and AF or atrial flutter with a resting ventricular rate > 110 beats per minute
- Evidence of right-sided HF in the absence of left sided structural heart disease
- Probable alternative diagnosis that in the opinion of the investigator could account for the patient's HF symptoms (i.e., anemia, hypothyroidism, severe obesity)
- World Health Organization Group 1 pulmonary hypertension, chronic pulmonary embolism, severe pulmonary disease, including COPD (i.e., requiring home oxygen, chronic nebulizer therapy or chronic oral steroid therapy, or hospitalization for exacerbation of COPD requiring ventilatory assist within 12 months prior to enrollment)
- Female patients who are pregnant, lactating, or considering becoming pregnant during the study or for 6 months after study completion
- Significant drug or alcohol abuse during the last year
- Current use of or plans to initiate chronic systemic steroid therapy during the study (topical or inhaled steroids are allowed)
- Chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis) or chronic diarrhea
- Use of other investigational drugs within 30 days of the time of enrollment
- Any surgical or medical condition, which in the opinion of the investigator, may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study
- Life expectancy < 2 years at the screening visit
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Center for Translational Cardiology and Pragmatic Randomized Trials, Herlev and Gentofte Hospital
Hellerup, 2900
Camilla Ikast Ottosen, MD, +4560222922, camilla.ikast.ottosen@regionh.dk
Tor Biering-Sørensen, MD, PhD, MPH, +4528933590, tor.biering-soerensen@regionh.dk
About this study
The purpose of this study is to investigate the effects of colchicine on heart failure related health status, quality of life, and vascular and cardiac function in patients with heart failure with preserved ejection fraction (HFpEF).
Read the detailed description
The study is an investigator-initiated, prospective, randomized, double-blind, placebo-controlled study of the effects of colchicine in patients with HFpEF. The study population will consist of approx. 152 patients aged 40 years and above, who meet the criteria of HFpEF. Patients will be randomized to either low-dose colchicine treatment (0.5 mg once daily) or placebo and treatment will continue for 6 months. Patients will be assessed with the Kansas City Cardiomyopathy Questionnaire (KCCQ) and have echocardiography performed at baseline and after 6 months. Furthermore, the investigators will obtain office blood pressure, ECG, Myovista ECG, 6-minute walk test, pulse wave velocity (PWV), and blood samples at baseline and after 6 months.
- Being tested
- Colchicine, Placebo
- Keywords
- Randomized Controlled Trial, Cardiovascular Diseases, Heart Diseases, Colchicine, Inflammation, Echocardiography, Hypertrophy, Left Ventricular, Ventricular Function, Left, Diastolic Dysfunction, Left Ventricular, Atrial Enlargement, Left, Quality of Life, Kansas City Cardiomyopathy Questionnaire
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Inflammation, Hypertrophy, Left Ventricular, Ventricular Dysfunction, Left
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColchicineDrug
0.5 mg once daily
PlaceboDrug
Once daily
| Study group | Role | What they receive |
|---|---|---|
| Colchicine | Experimental | Colchicine 0.5 mg once daily Receives: Drug: Colchicine |
| Placebo | Placebo comparator | Placebo once daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Between-group difference in change in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CS) at 6 months
The Kansas City Cardiomyopathy Questionnaire scores are scaled from 0-100 and frequently summarized in 25-point ranges, where scores represent health status as follows: 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; 75 to 100; good to excellent.
Measured: 6 months
Secondary outcomes (2)
Between-group difference in change in Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS) at 6 months
The Kansas City Cardiomyopathy Questionnaire scores are scaled from 0-100 and frequently summarized in 25-point ranges, where scores represent health status as follows: 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; 75 to 100; good to excellent.
Measured: 6 months
Between-group difference in the proportion of patients with a ≥ 5-point increase in KCCQ-CS and KCCQ-OS at 6 months
The Kansas City Cardiomyopathy Questionnaire scores are scaled from 0-100 and frequently summarized in 25-point ranges, where scores represent health status as follows: 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; 75 to 100; good to excellent.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start18 Jan 2024
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Preserved Ejection FractionStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tor Biering-Sørensen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tor Biering-Sørensen, Herlev and Gentofte Hospital
- Investigators
- Camilla Ikast Ottosen, MD, Principal investigator, Herlev and Gentofte Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06081049
- Sponsor's protocol ID
- COLHEART-PRESERVED
- Status last verified
- Feb 2024
- First submitted
- 3 Oct 2023
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The COLchicine HEART Failure PRESERVED Trial (COLHEART-PRESERVED)
- ClinicalTrials.gov ID
- NCT06081049
- Acronym / sponsor ID
- COLHEART-PRESERVED
- Keywords
- Randomized Controlled Trial, Cardiovascular Diseases, Heart Diseases, Colchicine, Inflammation, Echocardiography, Hypertrophy, Left Ventricular, Ventricular Function, Left
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- Tor Biering-SørensenUniversity, hospital or other
- Study start
- 18 Jan 2024 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 12 Oct 2023 (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.
The purpose of this study is to investigate the effects of colchicine on heart failure related health status, quality of life, and vascular and cardiac function in patients with heart failure with preserved ejection fraction (HFpEF).
Detailed description
The study is an investigator-initiated, prospective, randomized, double-blind, placebo-controlled study of the effects of colchicine in patients with HFpEF. The study population will consist of approx. 152 patients aged 40 years and above, who meet the criteria of HFpEF. Patients will be randomized to either low-dose colchicine treatment (0.5 mg once daily) or placebo and treatment will continue for 6 months. Patients will be assessed with the Kansas City Cardiomyopathy Questionnaire (KCCQ) and have echocardiography performed at baseline and after 6 months. Furthermore, the investigators will obtain office blood pressure, ECG, Myovista ECG, 6-minute walk test, pulse wave velocity (PWV), and blood samples at baseline and after 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colchicine | Experimental | Drug: ColchicineColchicine 0.5 mg once daily |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo once daily |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- LVEF ≥ 45% judged by echocardiography during the screening epoch or within 6 months prior to screening visit
- Symptom(s) of heart failure for at least 30 days prior to screening visit and current symptoms of heart failure (NYHA functional class II-IV) at screening visit
- Objective evidence of cardiac structural and/or functional abnormalities consistent with the presence of LV diastolic dysfunction/raised LV filling pressures (left atrial enlargement and/or left ventricular hypertrophy) judged by echocardiography at screening epoch or within 12 months prior to screening visit
- Raised pro-BNP ≥ 125 pg/ml (sinus rhythm) or ≥ 300 pg/ml (atrial fibrillation (AF)).
- Body Mass Index (BMI) < 40 kg/m2 at screening visit
Key exclusion criteria (30 listed)
- Colchicine treatment for another cause, e.g., gout
- Allergy/hypersensitivity to colchicine
- Uncontrolled hypertension (systolic BP >180 mmHg or diastolic BP >110 mmHg)
- History of malignancy of any organ system excluding a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma, localized prostate cancer and/or localized carcinoma in situ of the cervix
- Cirrhosis, chronic active hepatitis, or other severe hepatic disease
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 |
|---|---|---|
| Colchicine0.5 mg once daily | Drug | Colchicine |
| PlaceboOnce daily | Drug | Placebo |
Primary outcome
Between-group difference in change in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CS) at 6 months
Time frame: 6 months
The Kansas City Cardiomyopathy Questionnaire scores are scaled from 0-100 and frequently summarized in 25-point ranges, where scores represent health status as follows: 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; 75 to 100; good to excellent.
2 secondary outcomes
Between-group difference in change in Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS) at 6 months
Time frame: 6 months
Between-group difference in the proportion of patients with a ≥ 5-point increase in KCCQ-CS and KCCQ-OS at 6 months
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Individual participant dataSharing planned: Yes
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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.
Camilla Ikast Ottosen, MD principal investigator
Herlev and Gentofte Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Colchicine in people with Heart Failure With Preserved Ejection Fraction, run by Tor Biering-Sørensen at 1 site in Denmark.
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 7 inclusion and 30 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: status not confirmed, as of the sponsor's last update on 28 Feb 2024. 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 Denmark. 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. Some participants in this study may receive a placebo. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Camilla Ikast Ottosen, MD (+4560222922, camilla.ikast.ottosen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Between-group difference in change in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CS) at 6 months (time frame: 6 months). 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 28 Feb 2024.