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Could a gout drug tame high blood pressure?

NCT ID NCT04916522

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether colchicine, a drug used for gout, can improve blood vessel stiffness and heart function in people with high blood pressure. About 150 adults with hypertension and additional risks like diabetes or high cholesterol will take colchicine or a placebo daily for 6 months. Researchers will measure changes in artery stiffness, blood pressure, and heart size.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Colchicine (0.5 mg daily)
What this could lead to
If it works, this could point toward a new way to lower blood pressure and protect the heart in people with hypertension.
What could go wrong
This is a small, early-phase trial, so results may not apply to everyone. Colchicine can cause stomach upset or other side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2021

Expected to finish

Jan 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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: 1. Diagnosed with type 2 diabetes mellitus OR 2. Treatment with lipid-lowering medication for dyslipidemia OR 3. 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 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: 1. Hemoglobin \< 7 mmol/L 2. Platelet count \< 110 x 10\^9/L 3. 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

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

    Hellerup, 2900, Denmark

More trials for these conditions

Other studies related to the condition(s) this trial covers.