Exercise Capacity According to Coronary Microvascular Dysfunction and Body Composition

Heart Failure With Preserved Ejection Fraction (HFpEF) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04822649
• Other study ID #: 2020AN0030
• Status: Recruiting
• Phase: N/A
• Start date: April 15, 2021
• Est. completion date: December 2024

Study information

• Verified date: September 2023
• Source: Korea University Anam Hospital
• Contact: So Ree Kim, MD
• Phone: 821094534810
• Email: soree8826kim[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure With Preserved Ejection Fraction (HFpEF)

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Korea University Anam Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Korea University Anam Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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