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

ISRCTN	ISRCTN03253693
DOI	https://doi.org/10.1186/ISRCTN03253693
ClinicalTrials.gov number	NCT02236299
Secondary identifying numbers	17088

Submission date: 22/10/2014
Registration date: 22/10/2014
Last edited: 07/06/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Ms Clare East
Scientific

Papworth Everard
Cambridge
CB3 8RE
United Kingdom

Email	clare.east@papworth.nhs.uk

Study information

Study design	Randomised; Interventional; Design type: Treatment
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
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
Study acronym	DREAM GLP-1
Study objectives	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(s)	East of England - Cambridge South Research Ethics Committee, 13/06/2014, ref: 14/EE/0141
Health condition(s) or problem(s) studied	Topic: Cardiovascular disease; Subtopic: Cardiovascular (all Subtopics); Disease: Cardiovascular
Intervention	GLP-1, GLP-1
Intervention type	Other
Primary outcome measure	Improvement in RV diastolic dysfunction
Secondary outcome measures	Not provided at time of registration
Overall study start date	22/09/2014
Completion date	22/03/2016

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Planned Sample Size: 30; UK Sample Size: 30
Key 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
Key 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
Date of first enrolment	22/09/2014
Date of final enrolment	22/03/2016

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Papworth Everard

Cambridge
CB3 8RE
United Kingdom

Sponsor information

Papworth Hospital NHS Trust (UK)
Hospital/treatment centre

Papworth Everard
Cambridge
CB3 8RE
England
United Kingdom

"ROR"	https://ror.org/01qbebb31

Funders

Funder type

Government

NIHR CSO Healthcare Science Fellowship; Grant Codes: NIHRHCSD120314

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
HRA research summary			28/06/2023	No	No

Editorial Notes

07/06/2019: No publications found. Verifying results with principal investigator.
15/05/2018: No publications found, verifying study status with principal investigator.