Exercise Capacity According to Coronary Microvascular Dysfunction and Body Composition

NCT ID: NCT04822649

Last Updated: 2025-09-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-15
• Study Completion Date: 2025-12-31

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.

Conditions

Heart Failure With Preserved Ejection Fraction (HFpEF)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Heart failure with preserved ejection fraction

Adenosine stress echocardiography, body composition, and cardiopulmonary exercise test will be done in all of the enrolled patients. Left ventricular end-diastolic pressure will be assessed during coronary angiography.

Group Type: OTHER

Adenosine stress echocardiography with the evaluation of coronary artery blood flow

Intervention Type: 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.

Interventions

Adenosine 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.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Body composition analysis; Cardiopulmonary exercise test

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Korea University Anam Hospital

OTHER

Sponsor Role: lead

Responsible Party

Seong-Mi Park, M.D. Ph.D.

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Korea University Anam Hospital

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

So Ree Kim, MD

Role: CONTACT

soree8826kim@gmail.com

821094534810

Facility Contacts

So Ree Kim, MD

Role: primary

soree8826kim@gmail.com

References

Kim SR, Cho DH, Kim MN, Park SM. Rationale and Study Design of Differences in Cardiopulmonary Exercise Capacity According to Coronary Microvascular Dysfunction and Body Composition in Patients with Suspected Heart Failure with Preserved Ejection Fraction. Int J Heart Fail. 2021 Sep 14;3(4):237-243. doi: 10.36628/ijhf.2021.0029. eCollection 2021 Oct.

Reference Type: DERIVED

PMID: 36262558 (View on PubMed)

Other Identifiers

2020AN0030

Identifier Type: -

Identifier Source: org_study_id