Clinical trial NCT04822649: Exercise Capacity According to Coronary Microvascular Dysfunction and Body Composition
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure With Preserved Ejection Fraction (HFpEF)
Keywords: body composition, CPET, CFR, coronary microvascular dysfunction (CMD), frailty, HFpEF
Lead sponsor: Korea University Anam Hospital
Sponsor class: OTHER
First posted: 2021-03-30
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Correlation of coronary blood flow with cardiopulmonary exercise capacity
timeFrame: up to day 14
measure: Correlation of body composition with cardiopulmonary exercise capacity
timeFrame: up to day 14
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
Study officials:
References:
citation: 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.