Clinical Trial: Effect of ACE-Inhibition on Microvascular Function in Women With Assessed Microvascular Dysfunction

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Effect of ACE-Inhibition on Microvascular Function in Women With Assessed Microvascular Dysfunction and No Obstructive Coronary Artery Disease

Brief Summary: The aim of this study is to explore effects of long term treatment with ACE-inhibitor on the small vessel function assessed by coronary flow reserve (CFR) by transthoracic echocardiography and flow mediated dilation in normotensive patients with small vessel disease (CFR<2.2) and Angina Pectoris but no obstructive coronary artery disease.

Detailed Summary:

BACKGROUND Microvascular angina is proposed to be myocardial ischemia caused by microvascular dysfunction. When the microvasculature is dysfunctioning, blood flow in the coronary vessels does not increase sufficiently to meet oxygen demand leading to ischemia and pain. In the absence of stenosis of major coronary arteries, coronary flow reserve (CFR) reflects coronary microcirculation. Up to 50% of patients with angina and no obstructive coronary artery disease (CAD) have impaired CFR, which is a strong predictor of poor cardiovascular prognosis. Furthermore CFR has been shown to be associated with conventional risk factors; among these hypertension.

ACE-inhibitor treatment of patients with Angina Pectoris and/or essential hypertension and no stenosis on coronary angiogram improves CFR measured invasively by Doppler Guidewire or gas chromotography suggesting an effect of ACE inhibition on the microvasculature. Studies assessing the effect of ACE-inhibition in hypertensive and mild coronary artery disease patients with CFR assessed by positron emission tomography (PET) showed divergent results. One study showed an improvement on both resting and hyperaemic myocardial blood flow , another showed an increased myocardial perfusion reserve post treatment and a third failed to show any significant effect. If the effect seen on CFR is indirectly mediated via treatment of hypertension or if ACE-inhibition has a direct effect on the microvasculature continues to be uncertain in patients with microvascular angina. Some studies show an effect on CFR in both normotensive and hypertensive patients with microvascular angina whereas other studies only show an effect in hypertensive patients and not in normotensive. Treating patients with diabetes and a CFR>2.0 with ACE-inhibitor has also proven efficient in increasing CFR measured by transthoracic Doppler echocardiography (TTDE) supp
Sponsor: Bispebjerg Hospital

Current Primary Outcome: Change from baseline in coronary flow reserve to after intervention [ Time Frame: Patients are followed on average 6 months ]

Coronary flow reserve is assessed by non-invasive Trans-Thoracic Doppler Echocardiography (TTDE)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change from baseline in Seattle Angina Questionnaire to after intervention [ Time Frame: Patients are followed on average 6 months ]
    Evaluated by validated questionnaires: Seattle Angina Questionnaire
  • Change from baseline in Endothelial function to after intervention [ Time Frame: Patients are followed on average 6 months ]
    Endothelial function is assessed by flow mediated dilation of the brachial artery by ultrasound
  • Change from baseline in Systolic function by speckle tracking strain to after intervention [ Time Frame: Patients are followed on average 6 months ]
    strain assessed by speckle tracking echocardiography
  • Change from baseline in Roses questionnaire to after intervention [ Time Frame: Patients are followed on average 6 months ]
    Evaluated by validated questionnaires: Roses Questionnaire
  • Change from baseline in Vital exhaustion questionnaire to after intervention [ Time Frame: Patients are followed on average 6 months ]
    Evaluated by validated questionnaires: Vital exhaustion questionnaire
  • Change from baseline in International physical activity questionnaire (IPAQ) questionnaire to after intervention [ Time Frame: Patients are followed on average 6 months ]
    Evaluated by validated questionnaires: IPAQ questionnaire


Original Secondary Outcome: Same as current

Information By: Bispebjerg Hospital

Dates:
Date Received: August 3, 2015
Date Started: July 2015
Date Completion:
Last Updated: February 8, 2017
Last Verified: February 2017