The COLchicine HEART Failure PRESERVED Trial (COLHEART-PRESERVED)

NCT06081049 | Recruiting Phase 2

• 1 other identifier: COLHEART-PRESERVED
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Heart Failure With Preserved Ejection Fraction

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

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (2)

• Between-group difference in change in Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS) at 6 months

  6 months

• Between-group difference in the proportion of patients with a ≥ 5-point increase in KCCQ-CS and KCCQ-OS at 6 months

  6 months

Other Outcomes (25)

• Between-group difference in change in office-measured systolic blood pressure at 6 months

  6 months

• Between-group difference in change in office-measured diastolic blood pressure at 6 months

  6 months

• Between-group difference in change in exercise capacity assessed by 6-minute walk test at 6 months

  6 months

Study Arms (2)

Colchicine

EXPERIMENTAL

Colchicine 0.5 mg once daily

Drug: Colchicine

Placebo

PLACEBO COMPARATOR

Placebo once daily

Drug: Placebo

Interventions

Colchicine DRUG

0.5 mg once daily

Colchicine

Placebo DRUG

Once daily

Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Tor Biering-Sørensen: lead

Study Sites (1)

Center for Translational Cardiology and Pragmatic Randomized Trials, Herlev and Gentofte Hospital

Hellerup, 2900, Denmark

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases; Heart Diseases; Inflammation; Hypertrophy, Left Ventricular; Ventricular Dysfunction, Left

Interventions

Colchicine

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cardiomegaly; Hypertrophy; Pathological Conditions, Anatomical; Ventricular Dysfunction

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds

Study Officials

• Camilla Ikast Ottosen, MD

  Herlev and Gentofte Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Camilla Ikast Ottosen, MD

CONTACT

+4560222922; camilla.ikast.ottosen@regionh.dk

Tor Biering-Sørensen, MD, PhD, MPH

CONTACT

+4528933590; tor.biering-soerensen@regionh.dk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Head of Center for Translational Cardiology and Pragmatic Randomized Trials

Study Record Dates

• First Submitted: October 3, 2023
• First Posted: October 12, 2023
• Study Start: January 18, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share

Locations

DK (1)