Clinical Trial: Glucagon-like Peptide-1 and Coronary Microvascular Dysfunction in Women With Angina Pectoris and no Coronary Stenosis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Effect of Glucagon-like Peptide-1 Stimulation on Coronary Microvascular Dysfunction in Women With Angina Pectoris and no Obstructive Stenosis of Major Coronary Vessels

Brief Summary: The aim of the present study is to evaluate the effect of treatment with Liraglutide on the coronary microvasculature and angina symptoms, in overweight patients with microvascular dysfunction and angina pectoris but no coronary artery stenosis.

Detailed Summary:

Background:

Patients with symptoms and signs of ischemia are referred to coronary angiography (CAG) or CT angiography (CT-CAG). A significant proportion of these patients and especially women appear to have no obstructive coronary stenosis. Patients with angina-like symptoms and no macrovascular coronary stenosis have previously been considered without increased risk of major cardiovascular events, but novel data indicate that this assumption may not be true.

Abnormal coronary flow and metabolic response to stress have been reported, which is consistent with a possible microvascular ethology for the symptoms. Both endothelium- and non-endothelium dependent impaired coronary reactivity may contribute. The endothelium dependent component has been linked to risk factors and pro-inflammatory processes promoting atherosclerosis. The non-endothelium dependent mechanisms may involve vascular smooth muscle cells, undergoing alterations in phenotype in response to physiological and pathophysiological stimuli like hypertension and diabetes.

Both invasive and non-invasive diagnostic methods are available for the assessment of coronary microvascular dysfunction. In the absence of a flow limiting stenosis upstream, indirect measurement is possible by using transthoracic Doppler stress echocardiography (TTDSE). TTDSE provides assessment of coronary blood flow velocity in one of the major coronary vessels that can be used to determine coronary flow velocity reserve (CFR) after hyperemia. This method does primarily assess the non-endothelium dependent component of coronary microvascular dysfunction.

Despite reassurance that no stenosis on major coronary vessels is found, many patients continue to have chest pain resulting in emergency visit
Sponsor: Eva Prescott

Current Primary Outcome:

• Change from baseline in Coronary Flow Reserve [ Time Frame: Assessed at baseline, week 4 and week 18 ]
  Assessed by transthoracic doppler stress echocardiography
• Change from baseline in Angina Symptoms [ Time Frame: Assessed at baseline, week 4 and week 18 ]
  Assessed by the Seattle Angina Questionnaire

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Change in endothelial function [ Time Frame: Assessed at baseline, week 4 and week 18 ]
  Assessed by Flow Mediated Dilation of the brachial artery by ultrasound
• Change in cardiac function [ Time Frame: Assessed at baseline, week 4 and week 18 ]
  Assessed by speckle tracking echocardiography
• Change in body weight [ Time Frame: Assessed at baseline, week 4 and week 18 ]
• Change in body composition [ Time Frame: Assessed before and after treatment (week 4 and week 18) ]
  Assessed by dexa scan

Original Secondary Outcome: Same as current

Information By: Bispebjerg Hospital

Dates:
Date Received: November 8, 2015
Date Started: November 2015
Date Completion: December 2017
Last Updated: December 20, 2016
Last Verified: December 2016