Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04822649

Exercise Capacity According to Coronary Microvascular Dysfunction and Body Composition

The correlation of coronary microvascular function and body composition with cardiopulmonary exercise capacity will be assessed in patients with heart failure with preserved ejection fraction.

Recruiting

Interested in participating?

Request Info

Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Korea University Anam Hospital

Seoul, South Korea

Location status: Recruiting

Location contact

Mi-Na Kim

SUB_INVESTIGATOR

Seong-Mi Park

PRINCIPAL_INVESTIGATOR

So Ree Kim

SUB_INVESTIGATOR

So Ree Kim, MD

CONTACT

[email protected]

About this study

We will select the patients with chest pain or ischemic symptoms with non-obstructive coronary artery disease (<50% stenosis) in coronary angiography and preserved ejection fraction (≥50%) in echocardiography. All patients will undergo body composition analysis and adenosine stress echocardiography with the evaluation of coronary artery blood flow by Doppler echocardiography and maximal oxygen consumption (VO2 max) by cardiopulmonary exercise test (CPET). Left ventricular end-diastolic pressure will be assessed during coronary angiography. Coronary flow reserve (CFR) is defined as the ratio of peak to baseline mean diastolic velocity of coronary blood flow. The correlation of CFR and body composition with cardiopulmonary exercise capacity will be assessed.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 20 to 80
  • Typical/atypical chest pain or ischemic symptoms including dyspnea
  • No significant coronary artery stenosis (>50% stenosis) in coronary angiography or computed tomography
  • Left ventricular ejection fraction ≥50%

Exclusion criteria

  • More than moderate valvular heart disease
  • Congenital heart disease
  • Chronic renal failure (estimated glomerular filtration rate <30 ml/min/1.73m2) or end-stage renal failure undergoing hemodialysis or peritoneal dialysis
  • Asthma, chronic obstructive pulmonary disease and primary pulmonary hypertension
  • Receiving anticancer drugs
  • Vasculitis associated with autoimmune diseases
  • Patients with difficulty in performing exercise load evaluation (treadmill, bicycle ergometer)
  • Atrial fibrillation
  • Atrioventricular block with more than second degrees, symptomatic bradycardia, cryo-node failure syndrome, Wolff-Parkinson-White (WPW) patients

Treatment and study plan

Adenosine stress echocardiography with the evaluation of coronary artery blood flow

Diagnostic Test

The color Doppler flow of distal left anterior descending artery will be examined from the modified apical four-chamber view in the anterior interventricular groove.

In regard to body composition analysis, Using InBody S10, impedance is measured in 6 frequency bands (1 kilohertz (kHz), 5 kHz, 50 kHz, 250 kHz, 500 kHz, 1000 kHz) for each of 5 parts (right plate, left arm, torso, right leg, left leg). Reactance is measured in 3 frequency bands (5 kHz, 50 kHz, 250 kHz for each of 5 parts (right arm, left arm, torso, right leg, left leg).

By treadmill exercise test with modified Bruce protocol or bicycle ergometer for patients with orthopedic problems, maximal oxygen consumption (VO2 max) will be measured using the exhalation gas analysis.

Other names: Body composition analysis, Cardiopulmonary exercise test

Primary outcomes

  1. Correlation of coronary blood flow with cardiopulmonary exercise capacity

    Time frame: up to day 14

    Coronary blood flow is assessed by coronary flow reserve (CFR), which is defined as peak to baseline mean diastolic velocity of coronary flow.

    In regard to cardiopulmonary exercise capacity, maximal oxygen consumption (VO2max) will be assessed.

  2. Correlation of body composition with cardiopulmonary exercise capacity

    Time frame: up to day 14

    In body composition analysis, skeletal muscle mass and body fat mass will be assessed.

    In regard to cardiopulmonary exercise capacity, maximal oxygen consumption (VO2max) will be assessed.

Study contacts

Contact information is provided by the study sponsor or research team.

So Ree Kim, MD

CONTACT

[email protected]

821094534810

Sponsors and collaborators

Lead sponsor

Korea University Anam Hospital

Other

Registry information

Official study title

Differences in Cardiopulmonary Exercise Capacity According to Coronary Microvascular Dysfunction and Body Composition in Patients With Suspected Heart Failure With Preserved Ejection Fraction

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Mar 30, 2021
Registry last updated
Sep 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.