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Heart Failure With Preserved Ejection FractionHFpEF-CMDNCT04788576

Distribution and Clinical Implication of CMD in Patients With HFpEF Without Significant CAD

An observational study of Heart Failure With Preserved Ejection Fraction and Coronary Microvascular Dysfunction, run by Samsung Medical Center at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To evaluate the incidence of coronary microvascular dysfunction (CMD) and its' prognostic implication in patients who have diagnosed as heart failure with preserved ejection fraction (HFpEF) confirmed by HFA-PEFF scoring system without functionally significant coronary artery disease. Read more about this study

Who is it for?
Ages 19 years and older
What is being tested?
Invasive physiologic evaluation (fractional flow reserve, coronary flow reserve, index of microcirculatory resistance)
How many people
100 participants
Where
1 siteSouth Korea
Study dates
25 Jan 2021to 31 Dec 2024
Phase
Observational
Are there results?
None posted in the registry

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 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients who have diagnosed as heart failure with preserved ejection fraction (HFpEF) confirmed by HFA-PEFF scoring system without functionally significant coronary artery disease

Who may be able to join

  • Subject must be at least 19 years of age.
  • Subject with preserved ejection fraction (ejection fraction > 50%)
  • Subject presented with dyspnea on exertion (NYHA Grade 2 or more) and diagnosed as HFpEF using HFA-PEFF scoring system (HFA-PEFF ≥5 or 2-4 with abnormal stress test or invasive hemodynamic test)
  • Subject who clinically need coronary angiography
  • Subject who is able to voluntarily sign informed consent form

Who cannot join

  • Subject with reduced ejection fraction (<50%)
  • Subject with significant coronary artery stenosis on coronary angiography (diameter stenosis ≥90% or 50-90% with fractional flow reserve [FFR] ≤0.80)
  • Subject who has other obvious causes of dyspnea (ex, lung disease)
  • Subject who have non-cardiac co-morbid conditions with life expectancy <1 year

Trial locations and contacts

1 site in 1 country.

Ki Hong Choi, MD contact

82-2-3410-1246

cardiokh@gmail.com

South Korea1 site, 1 recruiting

  • Samsung Medical Center

    Seoul, 06351

    Ki Hong Choi, MD, 82-2-3410-3419, cardiokh@gmail.com

    Recruiting

Other trials in South Korea

About this study

Official title: Distribution and Clinical Implication of Coronary Flow Reserve and Index of Microcirculatory Resistance in Patients With Heart Failure With Preserved Ejection Fraction Without Significant Coronary Artery Disease

To evaluate the incidence of coronary microvascular dysfunction (CMD) and its' prognostic implication in patients who have diagnosed as heart failure with preserved ejection fraction (HFpEF) confirmed by HFA-PEFF scoring system without functionally significant coronary artery disease.

Read the detailed description

Heart failure with preserved ejection fraction (HFpEF) is a clinical syndrome in patients with current or prior symptoms of HF with a left ventricular ejection fraction (LVEF) ≥ 50 percent and evidence of cardiac dysfunction as a cause of symptoms (abnormal LV filling and elevated filling pressures). Previous studies have reported that HFpEF is related to various clinical risk factors such as hypertension, obesity, diabetes mellitus, chronic kidney disease, atrial fibrillation, myocardial ischemia with or without significant epicardial coronary artery stenosis, or myocardial infiltrative disease. Although its pathophysiology remains incompletely understood, findings from clinical and pre-clinical studies have suggested systemic endothelial dysfunction, oxidative stress, and coronary microvascular dysfunction (CMD) could be important pathophysiologic mechanisms for HFpEF.

In this regard, recent studies evaluated non-invasively measured coronary flow reserve (CFR) from positron emission tomography (PET), cardiac magnetic resonance imaging (MRI), or Doppler echocardiography, and presented the association of depressed global CFR with cardiac diastolic dysfunction and higher risk of clinical events. The presence of CMD can be also evaluated by invasive physiologic assessment using both CFR and index of microcirculatory resistance (IMR). Nevertheless, there has been limited study which evaluated the association between HFpEF and CMD using invasive physiologic indices and their prognostic implications, especially in patients without significant coronary artery stenosis. Therefore, we sought to evaluate the incidence of CMD and its' prognostic implication in patients who have diagnosed as heart failure with preserved ejection fraction (HFpEF) confirmed by HFA-PEFF scoring system without functionally significant coronary artery disease.

Being tested
Invasive physiologic evaluation (fractional flow reserve, coronary flow reserve, index of microcirculatory resistance)
Keywords
Heart failure with preserved ejection fraction, Coronary physiology, Coronary microvascular dysfunction, HFA-PEFF score

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Invasive physiologic evaluation (fractional flow reserve, coronary flow reserve, index of microcirculatory resistance)Diagnostic test

    In case of heart failure with preserved ejection fraction confirmed by HFA-PEFF scoring system without functionally significant coronary artery disease, coronary angiography with invasive physiologic evaluation including fractional flow reserve, coronary flow reserve, and index of microcirculatory resistance will be performed to evaluate the distribution and clinical implication of coronary microvascular dysfunction.

Study groups in NCT04788576
Study groupRoleWhat they receive
Patients with heart failure with preserved ejection fraction (HFpEF)Subject with preserved ejection fraction (ejection fraction > 50%) and with dyspnea on exertion (NYHA Grade 2 or more) and diagnosed as HFpEF using HFA-PEFF scoring system (HFA-PEFF ≥5 or 2-4 with abnormal stress test or invasive hemodynamic test)
Receives: Diagnostic Test: Invasive physiologic evaluation (fractional flow reserve, coronary flow reserve, index of microcirculatory resistance)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of CMD in patients with HFpEF

    Proportion of CMD confirmed by invasive physiologic evaluation

    Measured: Immediate after the index procedure

Secondary outcomes (18)

  1. Correlation between CMD and left ventricular end diastolic pressure

    Correlation between CMD confirmed by invasive physiologic evaluation and left ventricular end diastolic pressure

    Measured: Immediate after the index procedure

  2. Correlation between CMD and E/e'

    Correlation between CMD confirmed by invasive physiologic evaluation and E/e'

    Measured: Immediate after the index procedure

  3. Correlation between CMD and HFA-PEFF score

    Correlation between CMD confirmed by invasive physiologic evaluation and HFA-PEFF score

    Measured: Immediate after the index procedure

  4. Correlation between CMD and NT-proBNP

    Correlation between CMD confirmed by invasive physiologic evaluation and NT-proBNP

    Measured: Immediate after the index procedure

  5. Correlation between CMD and pulmonary artery wedge pressure

    Correlation between CMD confirmed by invasive physiologic evaluation and pulmonary artery wedge pressure

    Measured: Immediate after the index procedure

  6. Correlation between CMD and mean pulmonary artery pressure

    Correlation between CMD confirmed by invasive physiologic evaluation and mean pulmonary artery pressure

    Measured: Immediate after the index procedure

  7. All-cause death

    All-cause death during follow-up

    Measured: At 2 years after the index procedure

  8. Cardiac death

    Cardiac death during follow-up

    Measured: At 2 years after the index procedure

  9. Myocardial infarction

    Myocardial infarction during follow-up

    Measured: At 2 years after the index procedure

  10. Any revascularization

    Any revascularization during follow-up

    Measured: At 2 years after the index procedure

  11. Readmission due to heart failure

    Readmission due to heart failure during follow-up

    Measured: At 2 years after the index procedure

  12. Readmission

    Readmission during follow-up

    Measured: At 2 years after the index procedure

  13. Proportion of heart failure with reduced ejection fraction

    Proportion of progression of heart failure with reduced ejection fraction

    Measured: At 2 years after the index procedure

  14. Correlation between CMD and Excercise induced E/e'

    Correlation between CMD confirmed by invasive physiologic evaluation and exercise induced E/e'

    Measured: Immediate after the index procedure

  15. Correlation between CMD and Exercise induced pulmonary artery wedge pressure

    Correlation between CMD confirmed by invasive physiologic evaluation exercise induced and pulmonary artery wedge pressure

    Measured: Immediate after the index procedure

  16. Correlation between CMD and exercise time

    Correlation between CMD confirmed by invasive physiologic evaluation exercise time

    Measured: Immediate after the index procedure

  17. Correlation between CMD and mean exercise induced pulmonary artery pressure

    Correlation between CMD confirmed by invasive physiologic evaluation and exercise induced mean pulmonary artery pressure

    Measured: Immediate after the index procedure

  18. Correlation between CMD and Gas analysis data (Peak exercise oxygen consumption, Respiratory quotient)

    Correlation between CMD confirmed by invasive physiologic evaluation and exercise induced peak exercise oxygen consumption, Respiratory quotient

    Measured: Immediate after the index procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Mar 2021
  2. Study start25 Jan 2021
  3. Primary completion30 Sep 2024 (estimated)
  4. Study completion31 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04788576
Sponsor's protocol ID
HFpEF_CMD
Acronym
HFpEF-CMD
Status last verified
Jan 2024
First submitted
5 Mar 2021
Last updated
30 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Failure With Preserved Ejection Fraction and Coronary Microvascular Dysfunction, run by Samsung Medical Center 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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 30 Jan 2024. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ki Hong Choi, MD (82-2-3410-1246, cardiokh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of CMD in patients with HFpEF (time frame: Immediate after the index procedure). 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 NCT04788576.

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 30 Jan 2024.

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