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 (NCT) | NCT02236299 |
| Protocol serial number | 17088 |
| Sponsor | Papworth Hospital NHS Trust (UK) |
| Funder | NIHR CSO Healthcare Science Fellowship; Grant Codes: NIHRHCSD120314 |
- 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
Scientific
Papworth Everard
Cambridge
CB3 8RE
United Kingdom
| clare.east@papworth.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised; Interventional; Design type: Treatment |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Improvement in RV diastolic dysfunction |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 22/03/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Papworth Everard
Cambridge
CB3 8RE
United Kingdom
CB3 8RE
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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.
