COHERENT: The COlchicine HypERtENsion Trial

Sponsor
Herlev and Gentofte Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04916522
Collaborator
University of Copenhagen (Other)
150
1
2
27.7
5.4

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
COHERENT - The COlchicine HypERtENsion Trial
Actual Study Start Date :
Aug 10, 2021
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Colchicine

Colchicine 0.5 mg once daily

Drug: Colchicine
0.5 mg once daily

Placebo Comparator: Placebo

Placebo once daily

Drug: Placebo
Once daily

Outcome Measures

Primary Outcome Measures

  1. Between-group difference in change in carotid-femoral pulse wave velocity at 6 months [6 months]

Secondary Outcome Measures

  1. Between-group difference in change in office-measured systolic blood pressure at 6 months [6 months]

  2. Between-group difference in change in office-measured diastolic blood pressure at 6 months [6 months]

  3. Between-group difference in change in left ventricular mass assessed by echocardiography at 6 months [6 months]

  4. Between-group difference in change in left ventricular mass assessed by cardiac magnetic resonance imaging at 6 months [6 months]

  5. Between-group difference in change in high sensitivity C-reactive protein at 6 months [6 months]

  6. Between-group difference in change in high sensitivity Troponin I at 6 months [6 months]

Other Outcome Measures

  1. Between-group difference in change in office-measured pulse pressure at 6 months [6 months]

  2. Between-group difference in change in central blood pressure assessed by pulse wave analysis at 6 months [6 months]

  3. Between-group difference in change in augmentation index assessed by pulse wave analysis at 6 months [6 months]

  4. Between-group difference in change in left ventricular septal wall thickness assessed by echocardiography at 6 months [6 months]

  5. Between-group difference in change in left ventricular posterior wall thickness assessed by echocardiography at 6 months [6 months]

  6. Between-group difference in change in left ventricular ejection fraction assessed by echocardiography at 6 months [6 months]

  7. Between-group difference in change in E/A ratio assessed by echocardiography at 6 months [6 months]

  8. Between-group difference in change in e' assessed by echocardiography at 6 months [6 months]

  9. Between-group difference in change in E/e' assessed by echocardiography at 6 months [6 months]

  10. Between-group difference in change in E/e'sr assessed by echocardiography at 6 months [6 months]

  11. Between-group difference in change in left atrial volume assessed by echocardiography at 6 months [6 months]

  12. Between-group difference in change in global longitudinal strain assessed by echocardiography at 6 months [6 months]

  13. Between-group difference in change in myocardial work assessed by echocardiography at 6 months [6 months]

  14. Between-group difference in change in aortic distensibility assessed by echocardiography at 6 months [6 months]

  15. Between-group difference in change in aortic strain assessed by echocardiography at 6 months [6 months]

  16. Between-group difference in change in left ventricular septal wall thickness assessed by cardiac magnetic resonance imaging at 6 months [6 months]

  17. Between-group difference in change in left ventricular posterior wall thickness assessed by cardiac magnetic resonance imaging at 6 months [6 months]

  18. Between-group difference in change in left ventricular ejection fraction assessed by cardiac magnetic resonance imaging at 6 months [6 months]

  19. Between-group difference in change in left atrial volume assessed by cardiac magnetic resonance imaging at 6 months [6 months]

  20. Between-group difference in change in myocardial fibrosis assessed by cardiac magnetic resonance imaging at 6 months [6 months]

  21. Between-group difference in change in myocardial inflammation assessed by cardiac magnetic resonance imaging at 6 months [6 months]

  22. Between-group difference in change in tumor necrosis factor alpha at 6 months [6 months]

  23. Between-group difference in change in pro B-type natriuretic peptide at 6 months [6 months]

  24. Between-group difference in change in interleukin-1 beta at 6 months [6 months]

  25. Between-group difference in change in interleukin-6 at 6 months [6 months]

  26. Between-group difference in change in interleukin-10 at 6 months [6 months]

  27. Between-group difference in change in interleukin-17 at 6 months [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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:

  6. Diagnosed with type 2 diabetes mellitus OR

  7. Treatment with lipid-lowering medication for dyslipidemia OR

  8. Treatment with 2 or more antihypertensive medications

  9. 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

  10. Patients will have given written, informed consent and are able and willing to comply with the requirements of the study protocol

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:

  12. Hemoglobin < 7 mmol/L

  13. Platelet count < 110 x 10^9/L

  14. White blood cell count < 3.0 x 10^9/L

  15. Female patients who are pregnant, lactating, or considering becoming pregnant during the study or for 6 months after study completion

  16. Significant drug or alcohol abuse during the last year

  17. Current use of or plans to initiate chronic systemic steroid therapy during the study (topical or inhaled steroids are allowed)

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

  19. Use of other investigational drugs within 30 days of the time of enrollment

  20. 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cardiovascular Non-Invasive Imaging Research Laboratory, Department of Cardiology, Herlev and Gentofte Hospital Hellerup Denmark 2900

Sponsors and Collaborators

  • Herlev and Gentofte Hospital
  • University of Copenhagen

Investigators

  • Principal Investigator: Niklas Dyrby Johansen, MD, Herlev and Gentofte Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Niklas Dyrby Johansen, Principal Investigator, MD, Herlev and Gentofte Hospital
ClinicalTrials.gov Identifier:
NCT04916522
Other Study ID Numbers:
  • COHERENT
  • 2020-004492-40
First Posted:
Jun 7, 2021
Last Update Posted:
Aug 11, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Niklas Dyrby Johansen, Principal Investigator, MD, Herlev and Gentofte Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 11, 2021