Exercise Capacity According to Coronary Microvascular Dysfunction and Body Composition

NCT04822649 | Recruiting

• 1 other identifier: 2020AN0030
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure With Preserved Ejection Fraction (HFpEF)

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Correlation of coronary blood flow with cardiopulmonary exercise capacity

  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.

  up to day 14

• Correlation of body composition with cardiopulmonary exercise capacity

  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.

  up to day 14

Study Arms (1)

Heart failure with preserved ejection fraction

OTHER

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.

Diagnostic Test: Adenosine stress echocardiography with the evaluation of coronary artery blood flow

Interventions

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.

Also known as: Body composition analysis, Cardiopulmonary exercise test

Heart failure with preserved ejection fraction

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Korea University Anam Hospital: lead

Study Sites (1)

Korea University Anam Hospital

Seoul, South Korea

RECRUITING

Related Publications (1)

• 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.

  PMID: 36262558 DERIVED

MeSH Terms

Conditions

Frailty

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Central Study Contacts

So Ree Kim, MD

CONTACT

821094534810; soree8826kim@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: March 18, 2021
• First Posted: March 30, 2021
• Study Start: April 15, 2021
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)