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Recruiting NCT04822649

Exercise Capacity According to Coronary Microvascular Dysfunction and Body Composition

No phase Interventional Heart Failure With Preserved Ejection Fraction (HFpEF)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Adenosine stress echocardiography with the evaluation of coronary artery blood flow.
Who it may be relevant to
Registry conditions: Heart Failure With Preserved Ejection Fraction (HFpEF). Basic parameters: 20 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

Interventions

  • 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 ar

Primary outcome measures

  • Correlation of coronary blood flow with cardiopulmonary exercise capacity [Time frame: up to day 14]
  • Correlation of body composition with cardiopulmonary exercise capacity [Time frame: up to day 14]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

South Korea · 1 center
  • Korea University Anam Hospital — Seoul

Publications

  • 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

Identifiers

NCT: NCT04822649 · 2020AN0030

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗