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Glucagon-like Peptide-1 and Coronary Microvascular Dysfunction in Women With Angina Pectoris and no Coronary Stenosis (GAP)

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ClinicalTrials.gov Identifier: NCT02602600
Recruitment Status : Completed
First Posted : November 11, 2015
Last Update Posted : July 11, 2018
Sponsor:
Information provided by (Responsible Party):
Eva Prescott, Bispebjerg Hospital

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.

Condition or disease Intervention/treatment Phase
Microvascular Angina Drug: Liraglutide Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : November 19, 2015
Actual Primary Completion Date : April 18, 2017
Actual Study Completion Date : April 18, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angina

Arm Intervention/treatment
Experimental: Liraglutide
Liraglutide up to 3.0 mg daily injected subcutaneously (minimum 1.2 mg daily) for 12 weeks followed by 2 weeks of weight maintenance diet. Before initiating treatment participants will serve as their own controls for 4 weeks.
Drug: Liraglutide
  • Liraglutide up to 3 mg daily injected subcutaneously (minimum 1.2 mg daily) for 12 weeks.
  • Weight maintenance diet for 2 weeks
Other Name: Victoza




Primary Outcome Measures :
  1. Change from baseline in Coronary Flow Reserve [ Time Frame: Assessed at baseline, week 4 and week 18 ]
    Assessed by transthoracic doppler stress echocardiography

  2. Change from baseline in Angina Symptoms [ Time Frame: Assessed at baseline, week 4 and week 18 ]
    Assessed by the Seattle Angina Questionnaire


Secondary Outcome Measures :
  1. 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

  2. Change in cardiac function [ Time Frame: Assessed at baseline, week 4 and week 18 ]
    Assessed by speckle tracking echocardiography

  3. Change in body weight [ Time Frame: Assessed at baseline, week 4 and week 18 ]
  4. Change in body composition [ Time Frame: Assessed before and after treatment (week 4 and week 18) ]
    Assessed by dexa scan



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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women aged 40-75 with angina-like symptoms assessed by the Seattle Angina Questionnaire (SAQ).
  • Women aged 40-75 with angina-like symptoms assessed by the Seattle Angina Questionnaire (SAQ).
  • Referred for ischemic heart disease (IHD) assessment with no significant coronary stenosis (>50%) at coronary angiography or CT-angiography
  • Impaired CFR assessed by echo Doppler flow (defined ratio≤2,5).
  • BMI≥25kg/m2

Exclusion Criteria:

  • Allergy to dipyridamole, theophyllamine or liraglutide
  • Previous myocardial infarction or revascularization
  • No episodes of chest pain within 6 months before inclusion
  • Diabetes (reported, noted in journal or patient on antidiabetic medication)
  • Other causes of chest discomfort deemed highly likely
  • Left ventricular ejection fraction <45
  • Significant valvular disease
  • Congenital heart disease
  • severe co-morbidity with limited life-expectancy< 1 year
  • Severe asthma
  • Severe chronic obstructive pulmonary disease
  • Pregnancy (pregnancy test will be done at inclusion)
  • No use of contraception although in child-bearing age. A woman is regarded fertile, following menarche and until becoming post-menopausal unless permanently sterile. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. The birth control methods considered safe and effective includes combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), intrauterine device (IUD) and intrauterine hormone-releasing system ( IUS). Women in child-bearing age will have to use one of the above mentioned contraceptive methods from inclusion in the study until the end of study participation.
  • physical or mental disability
  • active cancer
  • significant renal (eGRF<30) or hepatic co-morbidity
  • chronic alcohol abuse
  • atrial fibrillation
  • Atrio-ventricular block>1st degree
  • chronic or previous acute pancreatitis
  • inflammatory bowel disease
  • history of thyroid carcinoma
  • participation in other clinical trial if relevant for the present study.
  • Language- or other barrier to giving informed consent
  • No signed informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02602600


Locations
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Denmark
Bispebjerg University Hospital
Copenhagen, Copenhagen Northwest, Denmark, 2400
Sponsors and Collaborators
Eva Prescott
Investigators
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Principal Investigator: Eva IB Prescott, MD, DMSc Bispebjerg Hospital

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Eva Prescott, MD, DMSc, Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT02602600     History of Changes
Other Study ID Numbers: GAP
First Posted: November 11, 2015    Key Record Dates
Last Update Posted: July 11, 2018
Last Verified: July 2018
Additional relevant MeSH terms:
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Liraglutide
Angina Pectoris
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Glucagon
Glucagon-Like Peptide 1
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Gastrointestinal Agents