Clinical trial NCT02236299: 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
Official 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 - DREAM GLP-1
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Right Coronary Artery Percutaneous Coronary Intervention
Right Ventricular Diastolic Dysfunction
Keywords: Right Coronary Artery
Percutaneous Coronary Intervention
Diastolic Dysfunction
Glucagon-like peptide-1
GLP-1
Stunning
Cardioprotection
Lead sponsor: Papworth Hospital NHS Foundation Trust
Sponsor class: OTHER_GOV
First posted: 2014-09-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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 the investigators 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. The investigators 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.


Eligibility criteria: Inclusion Criteria:

* Age over 18
* Able to give informed consent
* Elective percutaneous intervention for a single vessel right coronary artery stenosis \>75%
* Normal right ventricular function

Exclusion Criteria:

* Severe co-morbidity expected life (\<6months)
* Nicorandil or a GLP-1 receptor agonist or DPP-4 inhibitor use
* Women of child bearing age
* Myocardial infarction within the previous 3 months
* Previous coronary artery bypass graft to the RCA
* Significant known left to right shunt
* Permanent pacemaker
* Atrial fibrillation

Primary outcomes:
measure: Improvement in RV diastolic dysfunction (Tau, dP/dt min) between control and GLP-1 groups.
timeFrame: Change betweeen Balloon Occlusion One (Baseline) and Balloon Occlusion Two (30 minutes later)
Secondary outcomes:
measure: Improvement in RV systolic function (EF, dP/dt max), between control and GLP-1 groups.
timeFrame: Change betweeen Balloon Occlusion One (Baseline) and Balloon Occlusion Two (30 minutes later)
measure: Collaterals and microcirculatory differences between control and GLP-1 groups
timeFrame: Change betweeen Balloon Occlusion One (Baseline) and Balloon Occlusion Two (30 minutes later)
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Papworth Hospital NHS Foundation Turst
state: Cambridgeshire
Study officials:
affiliation: Papworth Hospital NHS Foundation Trust
name: Stephen P Hoole, BM BCh, MA, MD
role: STUDY_CHAIR
References:
citation: Read PA, Hoole SP, White PA, Khan FZ, O'Sullivan M, West NE, Dutka DP. A pilot study to assess whether glucagon-like peptide-1 protects the heart from ischemic dysfunction and attenuates stunning after coronary balloon occlusion in humans. Circ Cardiovasc Interv. 2011 Jun;4(3):266-72. doi: 10.1161/CIRCINTERVENTIONS.110.960476. Epub 2011 May 17.