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Exercise Capacity According to Coronary Microvascular Dysfunction and Body Composition

K

Korea University

Status

Enrolling

Conditions

Heart Failure With Preserved Ejection Fraction (HFpEF)

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT04822649
2020AN0030

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

100 participants in 1 patient group

Heart failure with preserved ejection fraction
Other group
Description:
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.
Treatment:
Diagnostic Test: Adenosine stress echocardiography with the evaluation of coronary artery blood flow

Trial contacts and locations

1

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Central trial contact

So Ree Kim, MD

Data sourced from clinicaltrials.gov

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