CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 62 enrolled
Drug / intervention
Medication (with statin and ACE-inhibition) +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02910154
NCT02910154N/ACompleted

Comprehensive Treatment of Angina in Women With Microvascular Dysfunction - a Proof of Concept Study of the iPower Cohort

Bispebjerg Hospital·interventional·Posted Sep 21, 2016·Updated Jun 23, 2020

In Brief

A clinical study evaluating Diet, Training, and 1 other intervention for Angina Pectoris and Coronary Microvascular Disease. Completed, enrolled 62 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesDenmark

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedSep 21, 2016
Enrollment StartDec 1, 2016
Primary CompletionOct 1, 2018
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 9.8 years ago

Interventions

Dietdietary

Weight loss achieved by following an evidence-based low energy diet of 800-1200 kcal/day for 12 weeks (Cambridge Weight Plan). Hereafter follow 12 weeks of 'weight maintenance' with consumption of normal heart healthy diet. Goal: total weight loss of at least 10% without significant loss of muscle mass. Monitored and supervised by a dietician

Trainingbehavioral

Aerobic interval training and resistance exercise in group sessions twice weekly throughout the 24-week intervention. Training intensity individually adapted to the restricted calorie intake. Goal: Improved VO2 peak (at least 10%). Monitored by a physiotherapist.

Medication (with statin and ACE-inhibition)drug

Medical treatment for hypertension and/or hypercholesterolemia if systolic blood pressure \> 130 and/or low density lipoprotein (LDL) \> 2.0.