Effect of Glucagon-like peptide-1 stimulation on the micro vessels of the heart in women with chest pain and no significant obstruction of major vessels of the heart.

Effect of Glucagon-like peptide-1 stimulation on coronary microvascular dysfunction in women with angina pectoris and no obstructive stenosis of major coronary vessels

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-002153-35-DK

Enrollment

Unknown

Registered

2015-07-27

Start date

2015-09-10

Completion date

Unknown

Last updated

2017-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with angina pectoris and coronary microvascular dysfunction without significant stenosis og major coronary vessels MedDRA version: 18.0 Level: LLT Classification code 10065566 Term: Microvascular angina System Organ Class: 100000004849

Interventions

Trade Name: Victoza Product Name: Liraglutide Pharmaceutical Form: Solution for injection in pre-filled pen INN or Proposed INN: LIRAGLUTIDE CAS Number: 204656-20-2 Concentration unit: mg/ml milligram

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - 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 coronary flow reserve assessed by echo Doppler flow - BMI=25kg/m2 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 16 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 17

Exclusion criteria

Exclusion criteria: - Allergy to dipyridamole, Teofyllamine 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 - LVEF1st degree - chronic or previous acute pancreatitis - inflammatory bowel disease - history of thyroid adenoma/carcinoma - participation in other RCT if relevant for the present study. - Language- or other barrier to giving informed consent - No signed informed consent

Design outcomes

Primary

Measure	Time frame
Main Objective: 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;Secondary Objective: To evaluate the effect of Liraglutide on - endothelial function assessed by flow mediated dilation (FMD) of the brachial artery by ultrasound. - cardiac function assessed by speckle tracking echocardiography - Weight loss - Change in body composition assessed by DEXA scan - serological markers ;Primary end point(s): - Changes in coronary flow reserve assessed by transthoracic doppler stress echocardiography (TTDSE). - Changes in symptoms assessed by Seattle Angina Questionnaire (SAQ) ;Timepoint(s) of evaluation of this end point: The endpoints will be evaluated after a control period of approximately 4 weeks not receiving any treatment and after 18 weeks (12 weeks of liraglutide treatment + 2 weeks of weight maintenance diet)	—

Measure

Time frame

Main Objective: 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;Secondary Objective: To evaluate the effect of Liraglutide on - endothelial function assessed by flow mediated dilation (FMD) of the brachial artery by ultrasound. - cardiac function assessed by speckle tracking echocardiography - Weight loss - Change in body composition assessed by DEXA scan - serological markers ;Primary end point(s): - Changes in coronary flow reserve assessed by transthoracic doppler stress echocardiography (TTDSE). - Changes in symptoms assessed by Seattle Angina Questionnaire (SAQ) ;Timepoint(s) of evaluation of this end point: The endpoints will be evaluated after a control period of approximately 4 weeks not receiving any treatment and after 18 weeks (12 weeks of liraglutide treatment + 2 weeks of weight maintenance diet)

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Secondary

Measure	Time frame
Secondary end point(s): - Changes in endothelial function assessed by flow mediated dilation (FMD) of the brachial artery by ultrasound. - Changes in cardiac function assessed by speckle tracking echocardiography - Weight loss - Change in body composition assessed by dual X-ray absoptionmetry (DEXA) scan - Changes in serological markers ;Timepoint(s) of evaluation of this end point: The endpoints will be evaluated after a control period of approximately 4 weeks not receiving treatment and after 18 weeks (12 weeks of liraglutide treatment + 2 weeks of weight maintenance diet) with the exception of the DEXA scan which will only be performed at baseline and after 18 weeks and with the exeption of weight, which will be assessed at each visit after initiation of treatment (7 visits).	—

Measure

Time frame

Secondary end point(s): - Changes in endothelial function assessed by flow mediated dilation (FMD) of the brachial artery by ultrasound. - Changes in cardiac function assessed by speckle tracking echocardiography - Weight loss - Change in body composition assessed by dual X-ray absoptionmetry (DEXA) scan - Changes in serological markers ;Timepoint(s) of evaluation of this end point: The endpoints will be evaluated after a control period of approximately 4 weeks not receiving treatment and after 18 weeks (12 weeks of liraglutide treatment + 2 weeks of weight maintenance diet) with the exception of the DEXA scan which will only be performed at baseline and after 18 weeks and with the exeption of weight, which will be assessed at each visit after initiation of treatment (7 visits).

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Countries

Denmark

Contacts

Public ContactEva Prescott

Bispebjerg University Hospital

Epre0004@regionh.dk

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026