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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Samsung Medical Center
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Proportion of CMD in patients with HFpEF
Study Overview
Brief 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.
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Proportion of CMD in patients with HFpEF
Time Frame: Immediate after the index procedure
Proportion of CMD confirmed by invasive physiologic evaluation
Secondary Outcomes
- Correlation between CMD and HFA-PEFF score(Immediate after the index procedure)
- Correlation between CMD and NT-proBNP(Immediate after the index procedure)
- Correlation between CMD and mean pulmonary artery pressure(Immediate after the index procedure)
- Readmission(At 2 years after the index procedure)
- Correlation between CMD and E/e'(Immediate after the index procedure)
- Correlation between CMD and pulmonary artery wedge pressure(Immediate after the index procedure)
- Correlation between CMD and left ventricular end diastolic pressure(Immediate after the index procedure)
- All-cause death(At 2 years after the index procedure)
- Any revascularization(At 2 years after the index procedure)
- Proportion of heart failure with reduced ejection fraction(At 2 years after the index procedure)
- Correlation between CMD and exercise time(Immediate after the index procedure)
- Cardiac death(At 2 years after the index procedure)
- Myocardial infarction(At 2 years after the index procedure)
- Readmission due to heart failure(At 2 years after the index procedure)
- Correlation between CMD and Excercise induced E/e'(Immediate after the index procedure)
- Correlation between CMD and Exercise induced pulmonary artery wedge pressure(Immediate after the index procedure)
- Correlation between CMD and mean exercise induced pulmonary artery pressure(Immediate after the index procedure)
- Correlation between CMD and Gas analysis data (Peak exercise oxygen consumption, Respiratory quotient)(Immediate after the index procedure)
Investigators
Ki Hong Choi
Clinical Assistant Professor
Samsung Medical Center