The COlchicine HypERtENsion Trial

The study is an investigator-initiated, prospective, double-blind, placebo-controlled, randomized clinical trial investigating the effects of colchicine in patients with hypertension. The study population will consist of approximately 150 patients aged 18 years and above with a diagnosis of hypertension and in active treatment with at least 1 antihypertensive drug. Patients will be randomized to either low-dose colchicine treatment (0,5 mg once daily) or placebo. Treatment will continue for 6 months. Patients will be assessed by measurement of pulse wave velocity (PWV), office blood pressure, echocardiography, cardiac MRI, and blood samples at baseline and after 6 months.

Inclusion criteria

• 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

Exclusion criteria

• 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
• Significant drug or alcohol abuse during the last year
• Current use of or plans to initiate chronic systemic steroid therapy during the study (topical or inhaled steroids are allowed)
• Chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis) or chronic diarrhea
• Use of other investigational drugs within 30 days of the time of enrollment
• Any surgical or medical condition, which in the opinion of the investigator, may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study.