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Trial · Interventional

CompletedPhase 4Registry data

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

Short name GAP

NCTNCT02602600 (opens ClinicalTrials.gov in a new tab)Other idGAP
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
33 participants (actual)
Sponsor
Eva Prescott · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

Denmark

Start
19 Nov 2015
Primary completion
18 Apr 2017
Completion
18 Apr 2017
First posted
11 Nov 2015 (estimated)
Last update posted
11 Jul 2018
Conditions
Microvascular Angina

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2015201620172018
  1. Ph 4

    GAP

    NCT02602600

    19 Nov 2015 to 18 Apr 2017

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • LiraglutideDrug

Arms1

  • 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.

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Change from baseline in Coronary Flow Reserve

    Time frame · Assessed at baseline, week 4 and week 18

    Registry description

    Assessed by transthoracic doppler stress echocardiography

  2. Change from baseline in Angina Symptoms

    Time frame · Assessed at baseline, week 4 and week 18

    Registry description

    Assessed by the Seattle Angina Questionnaire

Secondary outcomes(4)

  1. Change in endothelial function

    Time frame · Assessed at baseline, week 4 and week 18

    Registry description

    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

    Registry description

    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)

    Registry description

    Assessed by dexa scan

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies5

Studies that cite this trial.

Studies with results

4 studies on this page

Indexing hint: Randomized controlled trial · 2019

6 results

Effect of liraglutide on body weight and microvascular function in non-diabetic overweight women with coronary microvascular dysfunction.

Suhrs et al. 2019International journal of cardiologycited by 16

PMID 30773266DOI 10.1016/j.ijcard.2018.12.005PUB-30773266

Full text at the publisher6 results
Publisher pageSee results (6)

Indexing hint: Randomized controlled trial · 2015

6 results

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.

Faber et al. 2015Cardiovascular diabetologycited by 45

PMID 25896352PMC4407869DOI 10.1186/s12933-015-0206-3PUB-25896352

CC BY6 results
Download PDFSee results (6)

Indexing hint: Randomized controlled trial · 2013

6 results

Cardioprotective effects of exenatide in patients with ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention: results of exenatide myocardial protection in revascularization study.

Woo et al. 2013Arteriosclerosis, thrombosis, and vascular biologycited by 183

PMID 23868944DOI 10.1161/atvbaha.113.301586PUB-23868944

Rights unknown6 results
Source linkSee results (6)

Indexing hint: Randomized controlled trial · 2012

6 results

Exenatide reduces final infarct size in patients with ST-segment-elevation myocardial infarction and short-duration of ischemia.

Lønborg et al. 2012Circulation. Cardiovascular interventionscited by 181

PMID 22496084DOI 10.1161/circinterventions.112.968388PUB-22496084

Full text at the publisher6 results
Publisher pageSee results (6)

More studies

1 study on this page

PubMed tag: none · 2009

GLP-1R agonist liraglutide activates cytoprotective pathways and improves outcomes after experimental myocardial infarction in mice.

Noyan-Ashraf et al. 2009Diabetescited by 463

PMID 19151200PMC2661586DOI 10.2337/db08-1193PUB-19151200

Free to read · publisher termsCC BY-NC-ND
Read at source

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • ResultPatel 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. PMID 20220183
  • ResultJespersen L, Hvelplund A, Abildstrom SZ, Pedersen F, Galatius S, Madsen JK, Jorgensen E, Kelbaek H, Prescott E. Stable angina pectoris with no obstructive coronary artery disease is associated with increased risks of major adverse cardiovascular events. Eur Heart J. 2012 Mar;33(6):734-44. doi: 10.1093/eurheartj/ehr331. Epub 2011 Sep 11. PMID 21911339
  • ResultJohnson 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-sponsored Women's Ischaemia Syndrome Evaluation (WISE) study. Eur Heart J. 2006 Jun;27(12):1408-15. doi: 10.1093/eurheartj/ehl040. Epub 2006 May 23. PMID 16720691
  • ResultGulati 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 Ischemia Syndrome Evaluation Study and the St James Women Take Heart Project. Arch Intern Med. 2009 May 11;169(9):843-50. doi: 10.1001/archinternmed.2009.50. PMID 19433695
  • ResultPepine 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 and Blood Institute WISE (Women's Ischemia Syndrome Evaluation) study. J Am Coll Cardiol. 2010 Jun 22;55(25):2825-32. doi: 10.1016/j.jacc.2010.01.054. PMID 20579539
  • ResultReis 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: results from the NHLBI WISE study. Am Heart J. 2001 May;141(5):735-41. doi: 10.1067/mhj.2001.114198. PMID 11320360
  • ResultCamici PG, Crea F. Coronary microvascular dysfunction. N Engl J Med. 2007 Feb 22;356(8):830-40. doi: 10.1056/NEJMra061889. No abstract available. PMID 17314342
  • ResultJespersen 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. PLoS One. 2014 Apr 4;9(4):e93170. doi: 10.1371/journal.pone.0093170. eCollection 2014. PMID 24705387
  • ResultDi 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 Sci. 2014;18(3):374-9. PMID 24563437
  • ResultUssher JR, Drucker DJ. Cardiovascular actions of incretin-based therapies. Circ Res. 2014 May 23;114(11):1788-803. doi: 10.1161/CIRCRESAHA.114.301958. PMID 24855202
  • ResultNikolaidis 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-induced dilated cardiomyopathy. Circulation. 2004 Aug 24;110(8):955-61. doi: 10.1161/01.CIR.0000139339.85840.DD. Epub 2004 Aug 16. PMID 15313949
  • ResultBan 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. 2008 May 6;117(18):2340-50. doi: 10.1161/CIRCULATIONAHA.107.739938. Epub 2008 Apr 21. PMID 18427132
  • ResultMcCormick 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 diabetes mellitus and coronary artery disease. Circ Cardiovasc Imaging. 2014 Mar;7(2):274-81. doi: 10.1161/CIRCIMAGING.113.000785. Epub 2014 Feb 6. PMID 24503784
  • ResultRead 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):195-201. doi: 10.1161/CIRCIMAGING.109.899377. Epub 2010 Jan 14. PMID 20075143
  • ResultRead 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. PMID 21586690
  • ResultRead 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. PMID 21561896
  • ResultNikolaidis 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. doi: 10.1161/01.CIR.0000120505.91348.58. Epub 2004 Feb 23. PMID 14981009

Eligibility

Who could join, as posted.

Sex
Female
Age
from 40 Years up to 75 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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