Actively Recruiting
Colchicine in Acutely Decompensated HFREF
Led by University of Virginia · Updated on 2024-05-08
30
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a double blind, placebo-controlled pilot trial randomizing patients admitted to the hospital with acutely decompensated heart failure (ADHF) and inflammation to receive either colchicine or matching placebo. Upon enrollment, patients will be randomized 1:1 to receive either the experimental drug (Colchicine) or matching placebo. The regimen in the active arm will consist of 14 days of Colchicine 0.6 mg bid followed by 76±14 days of Colchicine 0.6 mg once per day. Placebo regimen will be analogous, with one pill bid for 14 days followed by one pill once per day for 76 days. Dose reduction for patients with Stage III chronic kidney disease is allowed as detailed in the protocol. At the same time, dose reduction can also be elected in case of GI symptoms. The study team will transiently stop the experimental medication in case of acute kidney injury (AKI), defined per Kidney Disease Improving Global Outcomes (KDIGO) Stage I, as specified in the protocol. These patients will continue with their standard of care for the management of heart failure which consists of a combination of medications that relieve congestion, normalize blood pressure and heart rate, and block the effects of hormones on the heart. The proposed treatment will be in addition to standard of care. No standard of care medications will be withheld. While inflammation is a known risk factor in heart failure, there are no standard anti-inflammatory drugs used in patients with heart failure, as the benefit is not established. The study team will study colchicine, an anti-inflammatory drug, as compares with placebo. Blood will be obtained from the patients in order to measure hsCRP and IL-6. Blood samples will be collected at baseline, 24±6h, 48±6h and 72±6h after treatment initiation, and subsequently at 14±7 days and at study closure. The first four blood samples will be obtained while the subject is still admitted to the hospital. The blood sample at 14±7 days will be obtained during an outpatient encounter. A study closure visit with clinical assessment and experimental drug collection for capsule counting to assess compliance will be conducted at 90±14; the final blood sample will be collected at that time.
CONDITIONS
Official Title
Colchicine in Acutely Decompensated HFREF
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Primary admission diagnosis of acute decompensated heart failure with symptoms and at least one of: pulmonary congestion/edema on exam or chest X-ray, E/e' > 13 on echocardiography, elevated left ventricular end-diastolic pressure >18 mmHg or pulmonary artery wedge pressure >16 mmHg, or elevated plasma B-type natriuretic peptide (>100 pg/ml) or NT-proBNP (>300 pg/ml)
- Left ventricular ejection fraction below 40% during current hospitalization or within past 12 months
- Heart failure duration expected to be at least three months
- Age 18 years or older
- Able and willing to provide written informed consent
- Screening plasma CRP >0.3 mg/dL (3 mg/L) or high-sensitivity CRP >2 mg/L
You will not qualify if you...
- Significant other illnesses that affect study participation or results, including acute coronary syndromes, uncontrolled blood pressure issues, arrhythmias, lung diseases, or neuromuscular respiratory disorders
- Cardiac resynchronization therapy, coronary artery procedures, or heart valve surgeries within past 3 months or planned during admission
- Previous or planned left ventricular assist device implantation or heart transplantation
- Chronic intravenous inotrope use
- Recent or current use of immunosuppressive or anti-inflammatory drugs (excluding NSAIDs) within 4 half-lives
- Current or planned colchicine treatment for gout within next 3 months
- Chronic inflammatory diseases such as rheumatoid arthritis or lupus
- Active infections or chronic infectious diseases including hepatitis B, hepatitis C, or HIV/AIDS
- Cancer within past 5 years except low-risk in situ lesions
- Any condition limiting expected survival to less than 3 months or ability to complete the study
- End-stage kidney disease requiring dialysis
- Low neutrophil count (<2,000/mm3) or low platelet count (<50,000/mm3)
- Pregnancy
- Contraindications to colchicine including prior adverse reactions, biliary obstruction, severe kidney impairment (eGFR <30 ml/min), or advanced liver cirrhosis
- Prisoner status
- Medications that cannot be used with colchicine such as protease inhibitors, certain antibiotics, antifungals, calcium channel blockers, aprepitant, ranolazine, or cyclosporine
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Trial Site Locations
Total: 1 location
1
UVA Health
Charlottesville, Virginia, United States, 22908
Actively Recruiting
Research Team
A
Austin Hogwood
CONTACT
F
Francesco Moroni, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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