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Exercise Capacity According to Coronary Microvascular Dysfunction and Body Composition

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04822649
Enrollment
100
Registered
2021-03-30
Start date
2021-04-15
Completion date
2025-12-31
Last updated
2025-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure With Preserved Ejection Fraction (HFpEF)

Keywords

body composition, CPET, CFR, coronary microvascular dysfunction (CMD), frailty, HFpEF

Brief summary

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.

Detailed description

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.

Interventions

DIAGNOSTIC_TESTAdenosine stress echocardiography with the evaluation of coronary artery blood flow

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.

Sponsors

Korea University Anam Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Correlation of coronary blood flow with cardiopulmonary exercise capacityup to day 14Coronary 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.
Correlation of body composition with cardiopulmonary exercise capacityup to day 14In 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.

Countries

South Korea

Contacts

Primary ContactSo Ree Kim, MD
soree8826kim@gmail.com821094534810

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 16, 2026