Microvascular Angina Clinical Trial
— GAPOfficial 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
Verified date | July 2018 |
Source | Bispebjerg Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 33 |
Est. completion date | April 18, 2017 |
Est. primary completion date | April 18, 2017 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 40 Years to 75 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Bispebjerg University Hospital | Copenhagen | Copenhagen Northwest |
Lead Sponsor | Collaborator |
---|---|
Eva Prescott |
Denmark,
Ban K, Noyan-Ashraf MH, Hoefer J, Bolz SS, Drucker DJ, Husain M. Cardioprotective and vasodilatory actions of glucagon-like peptide 1 receptor are mediated through both glucagon-like peptide 1 receptor-dependent and -independent pathways. Circulation. 200 — View Citation
Camici PG, Crea F. Coronary microvascular dysfunction. N Engl J Med. 2007 Feb 22;356(8):830-40. Review. — View Citation
Di Franco A, Villano A, Di Monaco A, Lamendola P, Russo G, Stazi A, Scavone G, Nerla R, Sestito A, Lanza GA, Crea F. Correlation between coronary microvascular function and angina status in patients with stable microvascular angina. Eur Rev Med Pharmacol — View Citation
Faber R, Zander M, Pena A, Michelsen MM, Mygind ND, Prescott E. Effect of the glucagon-like peptide-1 analogue liraglutide on coronary microvascular function in patients with type 2 diabetes - a randomized, single-blinded, cross-over pilot study. Cardiova — View Citation
Gulati M, Cooper-DeHoff RM, McClure C, Johnson BD, Shaw LJ, Handberg EM, Zineh I, Kelsey SF, Arnsdorf MF, Black HR, Pepine CJ, Merz CN. Adverse cardiovascular outcomes in women with nonobstructive coronary artery disease: a report from the Women's Ischemi — View Citation
Jespersen L, Abildstrom SZ, Hvelplund A, Madsen JK, Galatius S, Pedersen F, Hojberg S, Prescott E. Burden of hospital admission and repeat angiography in angina pectoris patients with and without coronary artery disease: a registry-based cohort study. PLo — View Citation
Jespersen L, Hvelplund A, Abildstrøm SZ, Pedersen F, Galatius S, Madsen JK, Jørgensen E, Kelbæk H, Prescott E. Stable angina pectoris with no obstructive coronary artery disease is associated with increased risks of major adverse cardiovascular events. Eu — View Citation
Johnson BD, Shaw LJ, Pepine CJ, Reis SE, Kelsey SF, Sopko G, Rogers WJ, Mankad S, Sharaf BL, Bittner V, Bairey Merz CN. Persistent chest pain predicts cardiovascular events in women without obstructive coronary artery disease: results from the NIH-NHLBI-s — View Citation
Lønborg J, Kelbæk H, Vejlstrup N, Bøtker HE, Kim WY, Holmvang L, Jørgensen E, Helqvist S, Saunamäki K, Terkelsen CJ, Schoos MM, Køber L, Clemmensen P, Treiman M, Engstrøm T. Exenatide reduces final infarct size in patients with ST-segment-elevation myocar — View Citation
McCormick LM, Kydd AC, Read PA, Ring LS, Bond SJ, Hoole SP, Dutka DP. Chronic dipeptidyl peptidase-4 inhibition with sitagliptin is associated with sustained protection against ischemic left ventricular dysfunction in a pilot study of patients with type 2 — View Citation
Nikolaidis LA, Elahi D, Hentosz T, Doverspike A, Huerbin R, Zourelias L, Stolarski C, Shen YT, Shannon RP. Recombinant glucagon-like peptide-1 increases myocardial glucose uptake and improves left ventricular performance in conscious dogs with pacing-indu — View Citation
Nikolaidis LA, Mankad S, Sokos GG, Miske G, Shah A, Elahi D, Shannon RP. Effects of glucagon-like peptide-1 in patients with acute myocardial infarction and left ventricular dysfunction after successful reperfusion. Circulation. 2004 Mar 2;109(8):962-5. E — View Citation
Noyan-Ashraf MH, Momen MA, Ban K, Sadi AM, Zhou YQ, Riazi AM, Baggio LL, Henkelman RM, Husain M, Drucker DJ. GLP-1R agonist liraglutide activates cytoprotective pathways and improves outcomes after experimental myocardial infarction in mice. Diabetes. 200 — View Citation
Patel MR, Peterson ED, Dai D, Brennan JM, Redberg RF, Anderson HV, Brindis RG, Douglas PS. Low diagnostic yield of elective coronary angiography. N Engl J Med. 2010 Mar 11;362(10):886-95. doi: 10.1056/NEJMoa0907272. Erratum in: N Engl J Med. 2010 Jul 29;3 — View Citation
Pedersen LR, Olsen RH, Jürs A, Astrup A, Chabanova E, Simonsen L, Wisløff U, Haugaard SB, Prescott E. A randomised trial comparing weight loss with aerobic exercise in overweight individuals with coronary artery disease: The CUT-IT trial. Eur J Prev Cardi — View Citation
Pepine CJ, Anderson RD, Sharaf BL, Reis SE, Smith KM, Handberg EM, Johnson BD, Sopko G, Bairey Merz CN. Coronary microvascular reactivity to adenosine predicts adverse outcome in women evaluated for suspected ischemia results from the National Heart, Lung — View 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 — View Citation
Read PA, Khan FZ, Dutka DP. Cardioprotection against ischaemia induced by dobutamine stress using glucagon-like peptide-1 in patients with coronary artery disease. Heart. 2012 Mar;98(5):408-13. doi: 10.1136/hrt.2010.219345. Epub 2011 May 10. — View Citation
Read PA, Khan FZ, Heck PM, Hoole SP, Dutka DP. DPP-4 inhibition by sitagliptin improves the myocardial response to dobutamine stress and mitigates stunning in a pilot study of patients with coronary artery disease. Circ Cardiovasc Imaging. 2010 Mar;3(2):1 — View Citation
Reis SE, Holubkov R, Conrad Smith AJ, Kelsey SF, Sharaf BL, Reichek N, Rogers WJ, Merz CN, Sopko G, Pepine CJ; WISE Investigators. Coronary microvascular dysfunction is highly prevalent in women with chest pain in the absence of coronary artery disease: r — View Citation
Ussher JR, Drucker DJ. Cardiovascular actions of incretin-based therapies. Circ Res. 2014 May 23;114(11):1788-803. doi: 10.1161/CIRCRESAHA.114.301958. Review. — View Citation
Woo JS, Kim W, Ha SJ, Kim JB, Kim SJ, Kim WS, Seon HJ, Kim KS. Cardioprotective effects of exenatide in patients with ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention: results of exenatide myocardial protect — View Citation
* Note: There are 22 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline in Coronary Flow Reserve | Assessed by transthoracic doppler stress echocardiography | Assessed at baseline, week 4 and week 18 | |
Primary | Change from baseline in Angina Symptoms | Assessed by the Seattle Angina Questionnaire | Assessed at baseline, week 4 and week 18 | |
Secondary | Change in endothelial function | Assessed by Flow Mediated Dilation of the brachial artery by ultrasound | Assessed at baseline, week 4 and week 18 | |
Secondary | Change in cardiac function | Assessed by speckle tracking echocardiography | Assessed at baseline, week 4 and week 18 | |
Secondary | Change in body weight | Assessed at baseline, week 4 and week 18 | ||
Secondary | Change in body composition | Assessed by dexa scan | Assessed before and after treatment (week 4 and week 18) |
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