A Phase 2 interventional study of Colchicine and Placebo in Hypertension, sponsored by Herlev and Gentofte Hospital. Active, not recruiting at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-22.
Sponsored by Herlev and Gentofte Hospital · Phase 2, Interventional, and Treatment
The purpose of this study to investigate the effects of colchicine on measures of vascular and cardiac function in patients with hypertension.
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.
6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.
This study's planned enrollment of 150 is above the median of 100 across 4,575 interventional studies indexed under Hypertension.
Browse Hypertension studies →Herlev and Gentofte Hospital is the lead sponsor of 75 studies on the registry; 25 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Must fulfill at least one of the following high-risk criteria:
Exclusion Criteria:
Anemia, thrombocytopenia or leucopenia defined as any of the following measurements within the last 3 months:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Colchicine 0.5 mg once daily
Drug: Colchicine
Placebo once daily
Drug: Placebo
0.5 mg once daily
Once daily
Between-group difference in change in carotid-femoral pulse wave velocity at 6 months
Time frame: 6 months
Between-group difference in change in office-measured systolic blood pressure at 6 months
Time frame: 6 months
Between-group difference in change in office-measured diastolic blood pressure at 6 months
Time frame: 6 months
Between-group difference in change in left ventricular mass assessed by echocardiography at 6 months
Time frame: 6 months
Between-group difference in change in left ventricular mass assessed by cardiac magnetic resonance imaging at 6 months
Time frame: 6 months
Between-group difference in change in high sensitivity C-reactive protein at 6 months
Time frame: 6 months
Between-group difference in change in high sensitivity Troponin I at 6 months
Time frame: 6 months
Between-group difference in change in office-measured pulse pressure at 6 months
Time frame: 6 months
Between-group difference in change in central blood pressure assessed by pulse wave analysis at 6 months
Time frame: 6 months
Between-group difference in change in augmentation index assessed by pulse wave analysis at 6 months
Time frame: 6 months
Between-group difference in change in left ventricular septal wall thickness assessed by echocardiography at 6 months
Time frame: 6 months
Between-group difference in change in left ventricular posterior wall thickness assessed by echocardiography at 6 months
Time frame: 6 months
Between-group difference in change in left ventricular ejection fraction assessed by echocardiography at 6 months
Time frame: 6 months
Between-group difference in change in E/A ratio assessed by echocardiography at 6 months
Time frame: 6 months
Between-group difference in change in e' assessed by echocardiography at 6 months
Time frame: 6 months
Between-group difference in change in E/e' assessed by echocardiography at 6 months
Time frame: 6 months
Between-group difference in change in E/e'sr assessed by echocardiography at 6 months
Time frame: 6 months
Between-group difference in change in left atrial volume assessed by echocardiography at 6 months
Time frame: 6 months
Between-group difference in change in global longitudinal strain assessed by echocardiography at 6 months
Time frame: 6 months
Between-group difference in change in myocardial work assessed by echocardiography at 6 months
Time frame: 6 months
Between-group difference in change in aortic distensibility assessed by echocardiography at 6 months
Time frame: 6 months
Between-group difference in change in aortic strain assessed by echocardiography at 6 months
Time frame: 6 months
Between-group difference in change in left ventricular septal wall thickness assessed by cardiac magnetic resonance imaging at 6 months
Time frame: 6 months
Between-group difference in change in left ventricular posterior wall thickness assessed by cardiac magnetic resonance imaging at 6 months
Time frame: 6 months
Between-group difference in change in left ventricular ejection fraction assessed by cardiac magnetic resonance imaging at 6 months
Time frame: 6 months
Between-group difference in change in left atrial volume assessed by cardiac magnetic resonance imaging at 6 months
Time frame: 6 months
Between-group difference in change in myocardial fibrosis assessed by cardiac magnetic resonance imaging at 6 months
Time frame: 6 months
Between-group difference in change in myocardial inflammation assessed by cardiac magnetic resonance imaging at 6 months
Time frame: 6 months
Between-group difference in change in tumor necrosis factor alpha at 6 months
Time frame: 6 months
Between-group difference in change in pro B-type natriuretic peptide at 6 months
Time frame: 6 months
Between-group difference in change in interleukin-1 beta at 6 months
Time frame: 6 months
Between-group difference in change in interleukin-6 at 6 months
Time frame: 6 months
Between-group difference in change in interleukin-10 at 6 months
Time frame: 6 months
Between-group difference in change in interleukin-17 at 6 months
Time frame: 6 months
Plan to share: Yes
This study is active, not recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Colchicine
Herlev and Gentofte Hospital