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Comprehensive Treatment of Angina in Women With Microvascular Dysfunction

NCT02910154 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2020-06-23

No results posted yet for this study

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.

Conditions

  • Angina Pectoris
  • Coronary Microvascular Disease

Interventions

DIETARY_SUPPLEMENT

Diet

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

BEHAVIORAL

Training

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.

DRUG

Medication (with statin and ACE-inhibition)

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

Sponsors & Collaborators

  • University Hospital Bispebjerg and Frederiksberg

    collaborator OTHER

  • Cambridge Weight Plan Limited

    collaborator INDUSTRY

  • Bispebjerg Hospital

    lead OTHER

Principal Investigators

  • Eva Prescott, MD, DMSc · Professor

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2018-10-01
Completion
2018-10-01

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02910154 on ClinicalTrials.gov