Distribution and Clinical Implication of CMD in Patients With HFpEF Without Significant CAD (HFpEF-CMD)
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| ClinicalTrials.gov Identifier: NCT04788576 |
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Recruitment Status :
Recruiting
First Posted : March 9, 2021
Last Update Posted : January 25, 2022
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| Condition or disease | Intervention/treatment |
|---|---|
| Heart Failure With Preserved Ejection Fraction Coronary Microvascular Dysfunction | Diagnostic Test: Invasive physiologic evaluation (fractional flow reserve, coronary flow reserve, index of microcirculatory resistance) |
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.
| Study Type : | Observational |
| Estimated Enrollment : | 100 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| 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 |
| Actual Study Start Date : | January 25, 2021 |
| Estimated Primary Completion Date : | September 30, 2024 |
| Estimated Study Completion Date : | December 31, 2024 |
| Group/Cohort | Intervention/treatment |
|---|---|
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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)
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Diagnostic Test: Invasive physiologic evaluation (fractional flow reserve, coronary flow reserve, index of microcirculatory resistance)
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. |
- Proportion of CMD in patients with HFpEF [ Time Frame: Immediate after the index procedure ]Proportion of CMD confirmed by invasive physiologic evaluation
- Correlation between CMD and left ventricular end diastolic pressure [ Time Frame: Immediate after the index procedure ]Correlation between CMD confirmed by invasive physiologic evaluation and left ventricular end diastolic pressure
- Correlation between CMD and E/e' [ Time Frame: Immediate after the index procedure ]Correlation between CMD confirmed by invasive physiologic evaluation and E/e'
- Correlation between CMD and HFA-PEFF score [ Time Frame: Immediate after the index procedure ]Correlation between CMD confirmed by invasive physiologic evaluation and HFA-PEFF score
- Correlation between CMD and NT-proBNP [ Time Frame: Immediate after the index procedure ]Correlation between CMD confirmed by invasive physiologic evaluation and NT-proBNP
- Correlation between CMD and pulmonary artery wedge pressure [ Time Frame: Immediate after the index procedure ]Correlation between CMD confirmed by invasive physiologic evaluation and pulmonary artery wedge pressure
- Correlation between CMD and mean pulmonary artery pressure [ Time Frame: Immediate after the index procedure ]Correlation between CMD confirmed by invasive physiologic evaluation and mean pulmonary artery pressure
- All-cause death [ Time Frame: At 2 years after the index procedure ]All-cause death during follow-up
- Cardiac death [ Time Frame: At 2 years after the index procedure ]Cardiac death during follow-up
- Myocardial infarction [ Time Frame: At 2 years after the index procedure ]Myocardial infarction during follow-up
- Any revascularization [ Time Frame: At 2 years after the index procedure ]Any revascularization during follow-up
- Readmission due to heart failure [ Time Frame: At 2 years after the index procedure ]Readmission due to heart failure during follow-up
- Readmission [ Time Frame: At 2 years after the index procedure ]Readmission during follow-up
- Proportion of heart failure with reduced ejection fraction [ Time Frame: At 2 years after the index procedure ]Proportion of progression of heart failure with reduced ejection fraction
- Correlation between CMD and Excercise induced E/e' [ Time Frame: Immediate after the index procedure ]Correlation between CMD confirmed by invasive physiologic evaluation and exercise induced E/e'
- Correlation between CMD and Exercise induced pulmonary artery wedge pressure [ Time Frame: Immediate after the index procedure ]Correlation between CMD confirmed by invasive physiologic evaluation exercise induced and pulmonary artery wedge pressure
- Correlation between CMD and exercise time [ Time Frame: Immediate after the index procedure ]Correlation between CMD confirmed by invasive physiologic evaluation exercise time
- Correlation between CMD and mean exercise induced pulmonary artery pressure [ Time Frame: Immediate after the index procedure ]Correlation between CMD confirmed by invasive physiologic evaluation and exercise induced mean pulmonary artery pressure
- Correlation between CMD and Gas analysis data (Peak exercise oxygen consumption, Respiratory quotient) [ Time Frame: Immediate after the index procedure ]Correlation between CMD confirmed by invasive physiologic evaluation and exercise induced peak exercise oxygen consumption, Respiratory quotient
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| Ages Eligible for Study: | 19 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04788576
| Contact: Ki Hong Choi, MD | 82-2-3410-1246 | cardiokh@gmail.com |
| Korea, Republic of | |
| Samsung Medical Center | Recruiting |
| Seoul, Korea, Republic of, 06351 | |
| Contact: Ki Hong Choi, MD 82-2-3410-3419 cardiokh@gmail.com | |
| Principal Investigator: | Ki Hong Choi, MD | Samsung Medical Center |
| Responsible Party: | Ki Hong Choi, Clinical Assistant Professor, Samsung Medical Center |
| ClinicalTrials.gov Identifier: | NCT04788576 |
| Other Study ID Numbers: |
HFpEF_CMD |
| First Posted: | March 9, 2021 Key Record Dates |
| Last Update Posted: | January 25, 2022 |
| Last Verified: | January 2022 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Heart failure with preserved ejection fraction Coronary physiology Coronary microvascular dysfunction HFA-PEFF score |
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Heart Failure Heart Diseases Cardiovascular Diseases |