Could a gout drug tame high blood pressure?
NCT ID NCT04916522
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
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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 Hide 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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Genom att skicka in godkänner du våra Användarvillkor
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
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Cardiovascular Non-Invasive Imaging Research Laboratory, Department of Cardiology, Herlev and Gentofte Hospital
Hellerup, 2900, Denmark
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