Rotigaptide in Endothelial Dysfunction?

NCT07192744 | Completed

• 1 other identifier: Roti II
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ischaemic Heart Diseases

Keywords

Ischaemia reperfusion; Gap junctions; Endothelial function

Outcome Measures

Primary Outcomes (1)

• Change in forearm blood flow after ischaemia reperfusion with or without co-infusion of Rotigaptide

  20 fixed timepoints throughout the study up to 4 hours

Study Arms (2)

1

PLACEBO COMPARATOR

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

Procedure: Forearm vascular study

2

ACTIVE COMPARATOR

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

Procedure: Forearm vascular study

Interventions

Forearm vascular study PROCEDURE

Forearm blood flow measured by venous occlusion plethysmography during interarterial infusion of vasodilators (Ach). Venous blood sampling via cannula in antecubital fossa.

1; 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Edinburgh: lead
• University of Aarhus: collaborator
• University of Oxford: collaborator

Study Sites (1)

University of Edinburgh, 49 Little France Crescent

Edinburgh, EH16 4SB, United Kingdom

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• David E Newby, PhD, FRCP

  University of Edinburgh

  STUDY DIRECTOR

• Rajesh K Kharbanda, PhD, FRCP

  University of Oxford

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2010
• First Posted: September 25, 2025
• Study Start: September 19, 2008
• Primary Completion: December 31, 2009
• Study Completion: December 31, 2009
• Last Updated: September 25, 2025

Record last verified: 2025-09

Locations

GB (1)