Assessing exercise capacity in heart failure patients with microvascular dysfunction and body composition analysis
Differences in Cardiopulmonary Exercise Capacity According to Coronary Microvascular Dysfunction and Body Composition in Patients With Suspected Heart Failure With Preserved Ejection Fraction
NA · Korea University Anam Hospital · NCT04822649
This study is testing how heart function, body makeup, and exercise ability are connected in people with heart failure who have chest pain but no blocked arteries.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 20 Years to 80 Years |
| Sex | All |
| Sponsor | Korea University Anam Hospital (other) |
| Locations | 1 site (Seoul) |
| Trial ID | NCT04822649 on ClinicalTrials.gov |
What this trial studies
This study evaluates the relationship between coronary microvascular function, body composition, and exercise capacity in patients suffering from heart failure with preserved ejection fraction (HFpEF). Participants will be selected based on specific criteria, including the presence of chest pain or ischemic symptoms and non-obstructive coronary artery disease. They will undergo body composition analysis and adenosine stress echocardiography to assess coronary blood flow, alongside a cardiopulmonary exercise test to measure maximal oxygen consumption. The study aims to correlate coronary flow reserve with exercise capacity and body composition metrics.
Who should consider this trial
Good fit: Ideal candidates are adults aged 20 to 80 with chest pain or ischemic symptoms and preserved ejection fraction without significant coronary artery stenosis.
Not a fit: Patients with significant valvular heart disease, chronic respiratory conditions, or those unable to perform exercise evaluations may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of exercise limitations in patients with HFpEF.
How similar studies have performed: While studies on coronary microvascular dysfunction and exercise capacity exist, this specific correlation with body composition in HFpEF patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Seoul
- Korea University Anam Hospital — Seoul, South Korea (RECRUITING)
Study contacts
- Study coordinator: So Ree Kim, MD
- Email: soree8826kim@gmail.com
- Phone: 821094534810
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Heart Failure With Preserved Ejection Fraction, body composition, CPET, CFR, coronary microvascular dysfunction, frailty, HFpEF