Clinical trial

Repurposing Colchicine to Improve Vascular Function in Hypertension

Name

Colchicine study

Description

In this project the potential beneficial effect of the drug colchicine on vascular reactivity and blood pressure will be assessed. Colchicine is a commonly used anti-inflammatory medication approved for the treatment of gout, Familial Mediterranean Fever and pericarditis in Denmark. The current project idea is based on accumulating evidence in the literature for a beneficial role of colchicine treatment in the prevention of cardiovascular disease in parallel with novel mechanistic insight from our own research. Recently, colchicine was associated with a lower risk of cardiovascular disease, including reduced myocardial infarctions, strokes and acute coronary syndrome . However, none of these trials have investigated the effect of colchicine on arterial tone or stiffness, changes to which may underlie the reduced risk of cardiovascular disease associated with colchicine. In support of the hypothesis that colchicine will improve vascular reactivity, a study in 1985 by Lagrue et al. found that daily, low-dose colchicine improved arterial stiffness in a small cohort of hypertensive patients. More recently, colchicine was shown to improve arterial stiffness in patients with Familial Mediterranean fever supporting a cardiovascular protective role of colchicine. Finally, colchicine is also proposed to have anti-inflammatory effects in the vascular system.

Trial arms

Trial start

2020-08-01

Estimated PCD

2022-12-01

Trial end

2023-02-28

Status

Completed

Treatment

Colchicine Tablets

patients with essential hypertension are randomized to receive either 3 weeks of colchicine

Arms:

Colchicine

Other names:

Colchicine

Placebo

patients with essential hypertension are randomized to receive either 3 weeks of placebo-treatment

Arms:

Placebo

Size

Primary endpoint

Changes in vascular function with treatment measured as flowchanges with ultrasound doppler in response to infusions of isoprenaline

Change in vascular conductance in response to infusions is assessed after acute treatment and before and within 72 hours after the 3 weeks of colchicine or placebo treatment

Changes in vascular function with training measured as flowchanges with ultrasound doppler divided by changes in blood pressure measured with intraarterial canula, in response to infusions of acetylcholine

Change in vascular conductance in response to infusions is assessed after acute treatment before and within 72 hours after the 3 weeks of colchicine or placebo treatment

Change in vascular conductance in response to infusions is assessed after acute treatment and before and within 72 hours after the 3 weeks of colchicine or placebo treatment

Eligibility criteria

Inclusion Criteria: * Diagnosed with essential hypertension * BMI\<30 * blood pressure (sys/dia) ≥120 mmhg and/or ≥80 mmhg while on hypertensive medication OR * blood pressure (sys/dia) ≥130 mmhg and/or ≥85 mmhg without hypertensive medication Exclusion Criteria: * smoking * excessive alcohol use * chronic diseases (beside essential hypertension)

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Single blinded randomized placebo-controlled intervention', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'Subjects are blinded and randomized to receive either colchicine-treatment or placebo', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 31, 'type': 'ACTUAL'}}

Updated at

2023-05-10

1 organization

1 product

1 drug

1 indication

Organization

University of Copenhagen

Product

Colchicine

Indication

Hypertension

Drug

Varlilumab