Heart Failure With Preserved Ejection Fraction (HFpEF)NCT04822649
Exercise Capacity According to Coronary Microvascular Dysfunction and Body Composition
A study testing Adenosine stress echocardiography with the evaluation of coronary artery blood flow in people with Heart Failure With Preserved Ejection Fraction (HFpEF), run by Korea University Anam Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction (HFpEF)
- What is being tested?
- Adenosine stress echocardiography with the evaluation of coronary artery blood flow
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Apr 2021to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Korea University Anam Hospital
Seoul
So Ree Kim, MD, soree8826kim@gmail.com
Seong-Mi Park
About this study
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
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.
Read the 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.
- Being tested
- Adenosine stress echocardiography with the evaluation of coronary artery blood flow
- Keywords
- body composition, CPET, CFR, coronary microvascular dysfunction (CMD), frailty, HFpEF
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adenosine stress echocardiography with the evaluation of coronary artery blood flowDiagnostic test
Also called Body composition analysis, Cardiopulmonary exercise test
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.
| Study group | Role | What they receive |
|---|---|---|
| Heart failure with preserved ejection fraction | Other | 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. Receives: Diagnostic Test: Adenosine stress echocardiography with the evaluation of coronary artery blood flow |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to day 14
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.
Measured: up to day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2021
- Study start15 Apr 2021
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart Failure With Preserved Ejection Fraction (HFpEF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korea University Anam Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seong-Mi Park, M.D. Ph.D., Korea University Anam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04822649
- Sponsor's protocol ID
- 2020AN0030
- Status last verified
- Aug 2025
- First submitted
- 18 Mar 2021
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 36262558
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04822649
- Acronym / sponsor ID
- 2020AN0030
- Keywords
- body composition, CPET, CFR, coronary microvascular dysfunction (CMD), frailty, HFpEF
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Korea University Anam HospitalUniversity, hospital or other
- Study start
- 15 Apr 2021 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 30 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Heart failure with preserved ejection fraction | Other | Diagnostic Test: Adenosine stress echocardiography with the evaluation of coronary artery blood flowAdenosine 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. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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%
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adenosine stress echocardiography with the evaluation of coronary artery blood flowAlso: Body composition analysis, Cardiopulmonary exercise testThe 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. | Diagnostic test | Heart failure with preserved ejection fraction |
Primary outcome
Correlation of coronary blood flow with cardiopulmonary exercise capacity
Time frame: up to day 14
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.
Correlation of body composition with cardiopulmonary exercise capacity
Time frame: up to day 14
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- Derived from this study: PubMed 36262558Kim 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adenosine stress echocardiography with the evaluation of coronary artery blood flow in people with Heart Failure With Preserved Ejection Fraction (HFpEF), run by Korea University Anam Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact So Ree Kim, MD (821094534810, soree8826kim@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of coronary blood flow with cardiopulmonary exercise capacity (time frame: up to day 14). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04822649, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2025.