Condition category
Circulatory System
Date applied
22/10/2014
Date assigned
22/10/2014
Last edited
22/10/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms Clare East

ORCID ID

Contact details

Papworth Everard
Cambridge
CB3 8RE
United Kingdom
clare.east@papworth.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

17088

Study information

Scientific title

Acronym

DREAM GLP-1 Study

Study hypothesis

The heart requires nutrients and oxygen carried in the blood to generate energy for healthy pump function. Blood is supplied via heart vessels called coronary arteries. When the arteries narrow we call this coronary artery disease. Narrowing and blockage of the coronary arteries can cause chest pain (angina), breathlessness (due to a reduction in pump function) and if prolonged even irreversible muscle damage known as a heart attack. We can treat patients with coronary artery disease with drugs that reduce the workload on the heart or with balloons and hollow metal tubes (stents) to open the narrowed coronary arteries and improve the blood supply. These treatments can relieve angina, improve breathlessness and avert heart muscle damage during a heart attack. A potential new mechanistic effect is emerging by modulating the type of fuel used by the heart to generate energy more efficiently has been tested in the left ventricle. This study is designed to see if mechanistic effect provides the same protection in the right ventricle. It is hoped that this may further improve heart pump function and reduce the size of a heart attack in patients with coronary artery disease.

Ethics approval

14/EE/0141

Study design

Randomised; Interventional; Design type: Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Topic: Cardiovascular disease; Subtopic: Cardiovascular (all Subtopics); Disease: Cardiovascular

Intervention

GLP-1, GLP-1

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Improvement in RV diastolic dysfunction

Secondary outcome measures

Not provided at time of registration

Overall trial start date

22/09/2014

Overall trial end date

22/03/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age over 18
2. Able to give informed consent
3. Elective percutaneous intervention for a single vessel right coronary artery stenosis >75%
4. Normal right ventricular function

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 30; UK Sample Size: 30

Participant exclusion criteria

1. Severe comorbidity expected life (<6months)
2. Nicorandil or a GLP1 receptor agonist or DPP4 inhibitor use
3. Women of child bearing age
4. Myocardial infarction within the previous 3 months
5. Previous coronary artery bypass graft to the RCA
6. Significant known left to right shunt
7. Permanent pacemaker
8. Atrial fibrillation

Recruitment start date

22/09/2014

Recruitment end date

22/03/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Papworth Everard
Cambridge
CB3 8RE
United Kingdom

Sponsor information

Organisation

Papworth Hospital NHS Trust (UK)

Sponsor details

Papworth Everard
Cambridge
CB3 8RE
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

NIHR CSO Healthcare Science Fellowship; Grant Codes: NIHRHCSD120314

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes