Exercise Capacity According to Coronary Microvascular Dysfunction and Body Composition

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Heart Failure With Preserved Ejection Fraction (HFpEF)

Intervention / Treatment
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* Diagnostic Test: Adenosine stress echocardiography with the evaluation of coronary artery blood flow


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Heart failure with preserved ejection fraction<br>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<br>* 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.<br>* Other names: Cardiopulmonary exercise test;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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body composition, CPET, CFR, coronary microvascular dysfunction (CMD), frailty, HFpEF