Repurposing Colchicine to Improve Vascular Function in Hypertension

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-01

Study Completion Date

2023-02-28

Brief Summary

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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.

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Detailed Description

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In this project w the potential beneficial effect of the drug colchicine on vascular reactivity and blood pressure is evaluated. 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 research of the investigators. 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 thehypothesis 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.

Conditions

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Essential Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Single blinded randomized placebo-controlled intervention

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Subjects are blinded and randomized to receive either colchicine-treatment or placebo

Study Groups

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Colchicine

3 weeks of treatment with colchicine

Group Type EXPERIMENTAL

Colchicine Tablets

Intervention Type DRUG

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

Placebo

3 weeks of placebo-treatment

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Colchicine Tablets

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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Colchicine

Eligibility Criteria

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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