Ischaemic Heart DiseasesNCT07192744
Rotigaptide in Endothelial Dysfunction?
A study testing Forearm vascular study in people with Ischaemic Heart Diseases, run by University of Edinburgh at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Ischaemic Heart Diseases
- What is being tested?
- Forearm vascular study
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Sep 2008to 31 Dec 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy males between 18-65 years of ages, non-smokers.
Who cannot join
- Any concurrent illness or chronic medical condition. Concurrent use of vasoactive medication. Smoking history.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Edinburgh, 49 Little France Crescent
Edinburgh, EH16 4SB
About this study
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
- Being tested
- Forearm vascular study
- Keywords
- Ischaemia reperfusion, Gap junctions, Endothelial function
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Forearm vascular studyProcedure or surgery
Forearm blood flow measured by venous occlusion plethysmography during interarterial infusion of vasodilators (Ach). Venous blood sampling via cannula in antecubital fossa.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: Forearm vascular study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in forearm blood flow after ischaemia reperfusion with or without co-infusion of Rotigaptide
Measured: 20 fixed timepoints throughout the study up to 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2025
- Study start19 Sep 2008
- Primary completion31 Dec 2009
- Study completion31 Dec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischaemic Heart DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- University of Aarhus, University of Oxford
- Responsible party
- Sponsor
- Investigators
- David E Newby, PhD, FRCP, Study director, University of EdinburghRajesh K Kharbanda, PhD, FRCP, Study director, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07192744
- Sponsor's protocol ID
- Roti II
- Status last verified
- Sep 2025
- First submitted
- 7 Apr 2010
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rotigaptide in Endothelial Dysfunction?
- ClinicalTrials.gov ID
- NCT07192744
- Acronym / sponsor ID
- Roti II
- Conditions
- Ischaemic Heart Diseases
- Keywords
- Ischaemia reperfusion, Gap junctions, Endothelial function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- University of Aarhus, University of Oxford
- Study start
- 19 Sep 2008 (actual)
- Primary completion
- 31 Dec 2009 (actual)
- Study completion
- 31 Dec 2009 (actual)
- First posted
- 25 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Procedure: Forearm vascular studyIschaemia 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 |
| 2 | Active comparator | Procedure: Forearm vascular studyIschaemia 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy males between 18-65 years of ages, non-smokers.
Key exclusion criteria (1 listed)
- Any concurrent illness or chronic medical condition. Concurrent use of vasoactive medication. Smoking history.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Forearm vascular studyForearm blood flow measured by venous occlusion plethysmography during interarterial infusion of vasodilators (Ach). Venous blood sampling via cannula in antecubital fossa. | Procedure or surgery | 1, 2 |
Primary outcome
Change in forearm blood flow after ischaemia reperfusion with or without co-infusion of Rotigaptide
Time frame: 20 fixed timepoints throughout the study up to 4 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David E Newby, PhD, FRCP study director
University of Edinburgh
Rajesh K Kharbanda, PhD, FRCP study director
University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Forearm vascular study in people with Ischaemic Heart Diseases, run by University of Edinburgh at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in forearm blood flow after ischaemia reperfusion with or without co-infusion of Rotigaptide (time frame: 20 fixed timepoints throughout the study up to 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2025.