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
NCT02236299
Protocol/serial number
17088
Study information
Scientific title
Diastolic RV EvAluation with Millar catheter to investigate the effect of Glucagon-Like Peptide-1 (GLP-1) on right ventricular function during elective coronary angioplasty and stenting
Acronym
DREAM GLP-1
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
East of England - Cambridge South Research Ethics Committee, 13/06/2014, ref: 14/EE/0141
Study design
Randomised; Interventional; Design type: Treatment
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
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
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