Comprehensive Treatment of Angina in Women With Microvascular Dysfunction

• Status: Completed
• Trial end date: 2018-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

Angina is the most common symptom of coronary heart disease among women but unlike men most women do not have stenosis of the coronary arteries. In a large proportion of these women, coronary microvascular dysfunction (CMD) is thought to be the cause of angina. However, CMD is also demonstrable in the asymptomatic population, and may merely be an innocent bystander related to the presence of cardiovascular risk factors rather than a cause of angina symptoms.

The aim of this study is to determine whether comprehensive intervention is feasible and results in improvement in both angina and microvascular function in these patients.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bispebjerg Hospital
• Collaborators: Cambridge Weight Plan Limited; University Hospital Bispebjerg and Frederiksberg

Criteria

Inclusion Criteria:

Patients will be recruited and included from the ongoing iPower study.(the acronym iPower stands for: improving diagnosis and treatment of women with angina pectoris and microvascular disease)

• Female gender

• 40-75 years of age

• Referred to a cardiac centre for assessment with coronary angiography due to chest pain or other signs of ischemia leaving out ST-segment elevation myocardial Infarction (STEMI) or NSTEMI patients (elevated enzymes, electrocardiographic (ECG) changes/no ECG changes)

• No significant stenotic lesions at the following coronary angiography defined as > 50% stenosis of epicardial vessels. Patients are included within 1 year after coronary angiography.

• Angina with a symptom burden of symptoms > monthly

• Impaired coronary microvascular function, defined as a Transthoracic Doppler Echocardiography measured CFVR < 2.5 with a good quality (quality index > 3)

• BMI > 26 or BMI >= 25 combined with a waist hip ratio of >=0.8

• Informed consent

Exclusion Criteria:

• Previously verified myocardial infarction, verified in medical records: ST-elevation myocardial infarction, elevated coronary markers or Non ST-elevation myocardial infarction

• Previous percutaneous coronary intervention or coronary artery bypass graft.

• Left ventricular ejection fraction (LVEF) < 45% assessed by echocardiography within 6 months before inclusion

• Any allergies to the content of the low energy diet (gluten/nuts), allergy to dipyridamole, adenosine, or theophyllamine

• Significant valvular heart disease

• Congenital heart disease

• Severe asthma

• Severe chronic obstructive pulmonary disease (COPD): forced expiratory volume in 1st second (FEV1) < 50% of predicted (age, height, ethnicity)

• Severe comorbidity with limited life-expectancy < 1 year

• Chest pain with a strongly suspected non-ischemic etiology (e.g. pericarditis, pneumonia)

• Pregnancy

• Active cancer

• Renal (eGFR < 30) or severe hepatic comorbidity

• Chronic alcohol abuse

• Atrial flutter or fibrillation

• Atrioventricular block > 1st degree

• Diabetes Mellitus type II patients in treatment with Sulphonylureas

• Participation in other trials if relevant for the present study

• Language- or other barrier to giving informed consent

• Physical or mental disabilities contraindicating or hampering diet or exercise training

• Travel distance to research hospital requiring more than 3 hours of travel, making it difficult for the patient to participate

Withdrawal criteria

• Sudden unexpected serious adverse reaction or sustained side effects

• Poor compliance will lead to withdrawal from the study at the mentioned time points:

Low energy diet: No weight loss within the first 3 weeks of the intervention period. Medication: < 80% of the prescribed medicine taken within the first 3 weeks. Training: < 50% attendance to training sessions/home training within the first 5 weeks.