protocolSection identificationModule nctId: NCT06286423, orgStudyIdInfo id: HSR220446, briefTitle: Colchicine in Acutely Decompensated HFREF, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2026-02, completionDateStruct date: 2028-02, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: University of Virginia, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Heart Failure, conditions: Decompensated Heart Failure, conditions: Heart Failure With Reduced Ejection Fraction, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The study team is planning to use controls in the present study. Controls will be patients from the target population, i.e. acutely decompensated heart failure with reduced ejection fraction., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Colchicine 0.6 mg, interventions name: Control/Placebo group, outcomesModule primaryOutcomes measure: Difference in the change in high sensitivity C-reactive protein (hsCRP) between colchicine arm and placebo arm in the first 72 hours of treatment, secondaryOutcomes measure: Difference in hsCRP area under curve between colchicine and placebo arm at 14 days, secondaryOutcomes measure: Difference in change in plasma IL-6 concentration between colchicine arm and placebo arm in the first 72 hours of treatment, otherOutcomes measure: Difference in the incidence of a composite of all-cause mortality or hospitalizations for heart failure at 90 days, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UVA Health, status: RECRUITING, city: Charlottesville, state: Virginia, zip: 22908, country: United States, contacts name: Austin Hogwood, role: CONTACT, email: ach2jb@virginia.edu, contacts name: Francesco Moroni, MD, role: CONTACT, email: nmf7mm@uvahealth.org, contacts name: Antonio Abbate, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.02931, lon: -78.47668, hasResults: False