Microvascular dysfunction/microvascular angina MedDRA version: 18.0 Level: LLT Classification code 10065566 Term: Microvascular angina System Organ Class: 100000004849
Conditions
Interventions
Trade Name: Ramipril
Pharmaceutical Form: Tablet
INN or Proposed INN: Ramipril
CAS Number: 87333-19-5
Other descriptive name: RAMIPRIL
Concentration unit: mg milligram(s)
Concentration type: equal
Con
Sponsors
Bipebjerg University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients from the iPower cohort with microvascular dysfunction defined as a TTDE measured CFR 3) examination who are normotensive will be included in the study. Patients with a CFR =65 years) yes F.1.3.1 Number of subjects for this age range 36
Exclusion criteria
Exclusion criteria: • Current treatment with ACE-inhibitors or Angiotensin II-antagonists • Atrial fibrillation • Pace-maker • Allergy towards Ace-inhibitor, Ramipril ® or tool-medicine: Dipyridamole/adenosine, Nitro-glycerine or rescue medicine: Theophylline • Baseline CFR >2.5 when entering ACIM-study. • No episodes of chest pain within 6 months before inclusion • Coronary angiography with significant stenotic lesions (>/=50%) • Other cause of chest discomfort deemed highly likely • Left ventricular ejection fraction below 45% assessed by echocardiography at baseline measurement • Significant valvular heart disease (Definition: Verified in medical records after echocardiography. If the echocardiographer in this study suspects valvular heart disease, the patient is referred for expert evaluation and excluded from the study until valvular disease has been excluded. All definitions are taken from the guidelines of the Danish Society of Cardiology (DCS). o Haemodynamic significant Aortic Stenosis: Valve area 6 mm, Moderate/severe LV volume load, ERO > 0.3 cm². o Mitral Stenosis (MS): Valve area 0.4 cm², Moderate/severe LV-load, Vena contracta > 6 mm. • Congenital heart disease or cardiomyopathy verified in medical records • Significant co-morbidity with 50 ng/l (high sensitive) or > 0.03 µg/l (4. generation), CKMB > 4.0 µg/l (women). • ECG with verified ST-segment elevation • Language- or other barrier to giving informed consent (for example mental ability to understand project) • Travel distance: a distance to research hospital requiring more than 3 hours of travel • Patient unwilling to participate (Low burden of symptoms, other illnesses, “Lack of energy”, transport problems, anxiety because of the examination, other). • No signed informed consent. • Other (Pregnancy, significant psychiatric disorder) • GFR < 50 mL/min/1,73 m2 WITHDRAWAL CRITERIA Patients who will be withdrawn from participating in the study: a) Suspected serious reaction where medication type will be unblinded by the sponsor by calling Glostrup pharmacy (open day and night) b) If they do not want to continue with treatment before total up titration of treatment c) Sustained side-effects which make the patients unable to take ACE-inhibitor/placebo before total up titration of treatment d) Poor compliance defined as less than 70 % of the time not taking ACE-inhibitor/placebo assessed by investigator. Patients will also be excluded with a more than 2 months continuous pause from medication or more than 2 weeks continuous pause up to endpoint measurements. e) Patients who do not
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: The secondary objectives of this study are to explore effects of long term treatment with ACE-inhibitor on the endothelial function assessed by flow mediated dilation (FMD), on symptoms and exercise level and on myocardial strain in rest and during stress assessed by echocardiography in normotensive patients with microvascular dysfunction (CFR<2.2) and Angina Pectoris but NO-CAD. ;Primary end point(s): Primary endpoint: CFR after treatment with ACE-inhibitor/placebo treatment in 6±1.5 months, assessed by a non-invasive Trans-Thoracic Doppler Echocardiography (TTDE). ;Timepoint(s) of evaluation of this end point: 6±1.5 months;Main Objective: The main objective of this study is to explore effects of long term treatment with ACE-inhibitor on the microvasculature assessed by coronary flow reserve by transthoracic echocardiography in normotensive patients with microvascular dysfunction (CFR<2.2) and Angina Pectoris but no coronary artery disease | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints: 1) Symptoms after 12±2 months of treatment with ACE-inhibitors assessed by Seattle angina questionnaire (annex 3) 2) exercise level assessed by iPAQ (annex 3) 3) strain assessed by speckle tracking echocardiography after 6±1.5 months of treatment with ACE-inhibitor 4) Endothelial function by FMD after treatment with ACE inhibitor in 6±1.5 months, assessed by flow mediated dilation of the brachial artery by ultrasound. ;Timepoint(s) of evaluation of this end point: 6±1.5 months | — |
Countries
Denmark
Contacts
Public Contacthttps://clinicaltrials.gov
Bispebjerg University Hospital
Outcome results
None listed