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HypertensionPhase 2COHERENTNCT04916522

The COlchicine HypERtENsion Trial

A Phase 2 study testing Colchicine in people with Hypertension, run by Herlev and Gentofte Hospital at 1 site in Denmark.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Hypertension
What is being tested?
Colchicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
150 participants
Where
1 siteDenmark
Study dates
10 Aug 2021to Jan 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

1 site in 1 country.

Denmark1 site

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

    Hellerup, 2900

Other trials in Denmark

About this study

Official title: COHERENT - The COlchicine HypERtENsion Trial

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

Read the 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.

Conditions
Hypertension
Being tested
Colchicine, Placebo
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
Medical subject headings
Hypertension, Inflammation, Hypertrophy, Left Ventricular, Endomyocardial Fibrosis, Atherosclerosis, Coronary Artery Disease, Cardiovascular Diseases, Heart Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ColchicineDrug

    0.5 mg once daily

  • PlaceboDrug

    Once daily

Study groups in NCT04916522
Study groupRoleWhat they receive
ColchicineExperimentalColchicine 0.5 mg once daily
Receives: Drug: Colchicine
PlaceboPlacebo comparatorPlacebo once daily
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 6 months

Secondary outcomes (6)

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

    Measured: 6 months

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

    Measured: 6 months

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

    Measured: 6 months

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

    Measured: 6 months

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

    Measured: 6 months

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

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jun 2021
  2. Study start10 Aug 2021
  3. Primary completionJan 2026 (estimated)
  4. Study completionJan 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04916522
Sponsor's protocol ID
COHERENT
Other IDs
2020-004492-40
Acronym
COHERENT
Status last verified
Dec 2025
First submitted
28 May 2021
Last updated
22 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Langhoff AF, Johansen ND, Frimodt-Moller M, Sajadieh A, Schramm TK, Jepps TA, Biering-Sorensen T. A Randomized Trial to Investigate the Effects of Low-Dose Colchicine in Patients with Hypertension: Rationale and Design of the COlchicine and HypERtENsion Trial (COHERENT). J Clin Hypertens (Greenwich). 2026 Jun;28(6):e70296. doi: 10.1111/jch.70296.

    PubMed 42210033

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Colchicine in people with Hypertension, run by Herlev and Gentofte Hospital at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Between-group difference in change in carotid-femoral pulse wave velocity at 6 months (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04916522, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.

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The COlchicine HypERtENsion Trial (NCT04916522) | AzTrials