Actively Recruiting
The COLchicine HEART Failure PRESERVED Trial (COLHEART-PRESERVED)
Led by Tor Biering-Sørensen · Updated on 2024-02-28
152
Participants Needed
1
Research Sites
123 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
The COLchicine HEART Failure PRESERVED Trial (COLHEART-PRESERVED)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Left ventricular ejection fraction (LVEF) of 45% or higher by echocardiography within 6 months before screening
- Symptoms of heart failure for at least 30 days before screening and current symptoms classified as NYHA class II to IV
- Evidence of heart structure or function abnormalities consistent with left ventricular diastolic dysfunction or raised filling pressures by echocardiography within 12 months before screening
- Raised pro-BNP levels: 125 pg/ml or higher if in sinus rhythm, or 300 pg/ml or higher if in atrial fibrillation
- Body Mass Index (BMI) less than 40 kg/m2 at screening
- Female participants must be either not of childbearing potential (postmenopausal at least 1 year or surgically sterile) or use hormonal or intrauterine contraception during the study and for 30 days after
- Able and willing to provide written informed consent and comply with study requirements
You will not qualify if you...
- Current colchicine treatment for other causes, such as gout
- Allergy or hypersensitivity to colchicine
- Uncontrolled high blood pressure (systolic >180 mmHg or diastolic >110 mmHg)
- History of cancer except successfully treated localized skin or prostate cancers or carcinoma in situ of the cervix
- Severe liver disease like cirrhosis or chronic active hepatitis
- Receiving hemodialysis
- Estimated glomerular filtration rate (eGFR) below 35 mL/min/1.73 m2
- Use of moderate or strong CYP3A4 or P-glycoprotein inhibitors
- Anemia, low platelet count, or low white blood cell count within past 3 months
- Recent acute decompensated heart failure (hospitalization within 7 days before screening)
- Recent major heart events or surgeries within 3 months before screening
- Planned major heart surgery or procedures during the trial
- Clinical events that might have lowered LVEF within 6 months unless confirmed LVEF ≥ 45%
- Recent stroke or carotid procedures within 3 months
- Previous heart transplant, complex congenital heart disease, or cardiac resynchronization therapy
- Heart failure due to specific cardiomyopathies or severe valvular disease
- Life-threatening or uncontrolled irregular heart rhythms
- Right-sided heart failure without left heart disease
- Alternative diagnoses explaining heart failure symptoms
- Severe pulmonary disease or pulmonary hypertension
- Pregnant, breastfeeding, or planning pregnancy during study or 6 months after
- Significant drug or alcohol abuse in last year
- Use or planned use of chronic systemic steroids during study
- Chronic inflammatory bowel disease or chronic diarrhea
- Use of other investigational drugs within 30 days before enrollment
- Any condition increasing risk or preventing study compliance
- Life expectancy less than 2 years at screening visit
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Center for Translational Cardiology and Pragmatic Randomized Trials, Herlev and Gentofte Hospital
Hellerup, Denmark, 2900
Actively Recruiting
Research Team
C
Camilla Ikast Ottosen, MD
CONTACT
T
Tor Biering-Sørensen, MD, PhD, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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