Rotigaptide in Endothelial Dysfunction?

University of Edinburgh

Status: Completed

Conditions: Ischaemic Heart Diseases

Treatments: Procedure: Forearm vascular study

Study type: Interventional

Funder types: Other

Identifiers

NCT07192744

Roti II

Details and patient eligibility

About

Arterial occlusion can lead to tissue ischemia and, if prolonged, end organ infarction. Clinical and experimental data would suggest that restoration of blood flow might trigger additional injury beyond that induced by the ischemia alone, so called Ischemia Reperfusion (IR) injury. IR injury impairs endothelial function through a mechanism that may involve intercellular gap junctions. Rotigaptide (ZP-123) is an anti-arrhythmic drug promoting intercellular coupling by increasing gap junction conductance. We intend to test the hypothesis that rotigaptide protects the forearm arterial circulation from IR-induced endothelial dysfunction.

Enrollment: 12 patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• healthy males between 18-65 years of ages, non-smokers.

Exclusion criteria

• Any concurrent illness or chronic medical condition. Concurrent use of vasoactive medication. Smoking history.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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12 participants in 2 patient groups, including a placebo group

1

Placebo Comparator group

Description:

Ischaemia reperfusion (IR) injury (upper arm cuff inflated to 200 mmHg for 20 min) is induced during the study. Using bilateral forearm venous occlusion plethysmography, blood flow will be measured during intra-brachial infusion of acetylcholine (ACh; 5-20 µg/min) before and after IR injury and during intra-brachial co-infusion of saline-placebo

Treatment:

Procedure: Forearm vascular study

2

Active Comparator group

Description:

Ischaemia reperfusion (IR) injury (upper arm cuff inflated to 200 mmHg for 20 min) is induced during the study. Using bilateral forearm venous occlusion plethysmography, blood flow will be measured during intra-brachial infusion of acetylcholine (ACh; 5-20 µg/min) before and after IR injury and during intra-brachial co-infusion of rotigaptide

Treatment:

Procedure: Forearm vascular study