The COlchicine HypERtENsion Trial

NCT04916522 | Active Not Recruiting Phase 2

• 2 other identifiers: COHERENT2020-004492-40
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study to investigate the effects of colchicine on measures of vascular and cardiac function in patients with hypertension.

Conditions

Hypertension

Keywords

Inflammation; Vascular Stiffness; Pulse Wave Analysis; Blood Pressure; Echocardiography; Magnetic Resonance Imaging; Computed Tomography Angiography; Hypertrophy, Left Ventricular; Ventricular Function, Left; Endomyocardial Fibrosis; Atherosclerosis; Coronary Atherosclerosis; Colchicine; Cardiovascular Diseases; Heart Diseases; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Between-group difference in change in carotid-femoral pulse wave velocity at 6 months

  6 months

Secondary Outcomes (6)

• 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 left ventricular mass assessed by echocardiography at 6 months

  6 months

• Between-group difference in change in left ventricular mass assessed by cardiac magnetic resonance imaging at 6 months

  6 months

• Between-group difference in change in high sensitivity C-reactive protein at 6 months

  6 months

Other Outcomes (27)

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

  6 months

• Between-group difference in change in central blood pressure assessed by pulse wave analysis at 6 months

  6 months

• Between-group difference in change in augmentation index assessed by pulse wave analysis 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: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Living address in the Capital Region of Denmark
• Age \>18 years
• Diagnosed with hypertension
• Treatment with 1 or more antihypertensive medications
• Must fulfill at least one of the following high-risk criteria:
• Diagnosed with type 2 diabetes mellitus OR
• Treatment with lipid-lowering medication for dyslipidemia OR
• Treatment with 2 or more antihypertensive medications
• Female patients should either not be of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile, or is 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
• Known or suspected secondary hypertension, e.g. renal artery stenosis
• Uncontrolled hypertension (systolic BP \>180 mmHg or diastolic BP \>110 mmHg)
• Known other cardiovascular disease (judged by the investigator), e.g. ischemic heart disease, heart failure, significant valvular disease, arrhythmia, stroke, or peripheral artery disease
• 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) \< 60 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 10\^9/L
• White blood cell count \< 3.0 x 10\^9/L
• Female patients who are pregnant, lactating, or considering becoming pregnant during the study or for 6 months after study completion

Sponsors & Collaborators

• Herlev and Gentofte Hospital: lead
• University of Copenhagen: collaborator

Study Sites (1)

Cardiovascular Non-Invasive Imaging Research Laboratory, Department of Cardiology, Herlev and Gentofte Hospital

Hellerup, 2900, Denmark

Location

MeSH Terms

Conditions

Hypertension; Inflammation; Hypertrophy, Left Ventricular; Endomyocardial Fibrosis; Atherosclerosis; Coronary Artery Disease; Cardiovascular Diseases; Heart Diseases

Interventions

Colchicine

Condition Hierarchy (Ancestors)

Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cardiomegaly; Hypertrophy; Pathological Conditions, Anatomical; Cardiomyopathies; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds

Study Officials

• Niklas Dyrby Johansen, MD

  Herlev and Gentofte Hospital

  PRINCIPAL INVESTIGATOR

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: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, MD

Study Record Dates

• First Submitted: May 28, 2021
• First Posted: June 7, 2021
• Study Start: August 10, 2021
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

DK (1)