Hypertension MedDRA version: 21.1 Level: LLT Classification code 10081425 Term: Arterial hypertension System Organ Class: 10047065 - Vascular disorders MedDRA version: 22.0 Level: PT Classification code 10081902 Term: Arterial stiffness System Organ Class: 10047065 - Vascular disorders
Conditions
Interventions
Trade Name: Colchicine
Product Name: Colchicine
Pharmaceutical Form: Tablet
INN or Proposed INN: COLCHICINE
CAS Number: 64-86-8
Other descriptive name: COLCHICINE
Concentration unit: mg milligram(s)
C
Sponsors
Cardiovascular Non-Invasive Imaging Research Laboratory, Department of Cardiology, Herlev and Gentofte Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Living address in the Capital Region of Denmark 2) Age >18 years 3) Diagnosed with hypertension 4) Treatment with 1 or more antihypertensive medications 5) Must fulfill at least one of the following high-risk criteria: a) Diagnosed with type 2 diabetes mellitus OR b) Treatment with lipid-lowering medication for dyslipidemia OR c) Treatment with 2 or more antihypertensive medications 6) 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 7) Patients will have given written, informed consent and are able and willing to comply with the requirements of the study protocol Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 75 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 75
Exclusion criteria
Exclusion criteria: 1) Colchicine treatment for another cause, e.g. gout 2) Allergy/hypersensitivity to colchicine 3) Known or suspected secondary hypertension, e.g. renal artery stenosis 4) Uncontrolled hypertension (systolic BP >180 mmHg or diastolic BP >110 mmHg) 5) Known other cardiovascular disease (judged by the investigator), e.g. ischemic heart disease, heart failure, significant valvular disease, arrhythmia, stroke, or peripheral artery disease 6) 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 7) Cirrhosis, chronic active hepatitis or other severe hepatic disease 8) Hemodialysis 9) Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2 10) Systemic treatment with moderate or strong cytochrome P450 3A4 (CYP3A4) inhibitors or P-glycoprotein inhibitors 11) 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 12) Female patients who are pregnant, lactating, or considering becoming pregnant during the study or for 6 months after study completion 13) Significant drug or alcohol abuse during the last year 14) Current use of or plans to initiate chronic systemic steroid therapy during the study (topical or inhaled steroids are allowed) 15) Chronic inflammatory bowel disease (Crohn’s disease or ulcerative colitis) or chronic diarrhea 16) Use of other investigational drugs within 30 days of the time of enrollment 17) 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to investigate the effect of colchicine on arterial stiffness as assessed by pulse wave velocity analysis in patients with hypertension compared to placebo;Secondary Objective: - To investigate the effect of colchicine on office-measured systolic and diastolic blood pressure compared to placebo - To investigate the effect of colchicine on cardiac structure and function as assessed by echocardiography and cardiac MRI compared to placebo - To investigate the effect of colchicine on inflammatory and cardiac biomarkers compared to placebo;Primary end point(s): Change in carotid-femoral pulse wave velocity;Timepoint(s) of evaluation of this end point: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Change in office-measured systolic blood pressure - Change in office-measured diastolic blood pressure - Change in LV mass index assessed by echocardiography - Change in LV mass index assessed by cardiac MRI - Change in hs-CRP - Change in hs-TnI;Timepoint(s) of evaluation of this end point: 6 months | — |
Countries
Denmark
Contacts
Public ContactNiklas Dyrby Johansen
Cardiovascular Non-Invasive Imaging Research Laboratory
Outcome results
None listed