The COlchicine HypERtENsion Trial

Prior treatment

• Systemic treatment with moderate or strong cytochrome P450 3A4 (CYP3A4) inhibitors or P-glycoprotein inhibitors
• 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)
• Use of other investigational drugs within 30 days of the time of enrollment

Other illness

• 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
• Chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis) or chronic diarrhea
• 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.

Lab values

• Estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73 m2
• 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

Other

• Colchicine treatment for another cause, e.g. gout
• Hemodialysis
• Female patients who are pregnant, lactating, or considering becoming pregnant during the study or for 6 months after study completion

• 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