Clinical trial NCT04788576: Distribution and Clinical Implication of CMD in Patients With HFpEF Without Significant CAD
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Failure With Preserved Ejection Fraction
Coronary Microvascular Dysfunction
Keywords: Heart failure with preserved ejection fraction
Coronary physiology
Coronary microvascular dysfunction
HFA-PEFF score
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2021-03-09
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of CMD in patients with HFpEF
timeFrame: Immediate after the index procedure
Secondary outcomes:
measure: Correlation between CMD and left ventricular end diastolic pressure
timeFrame: Immediate after the index procedure
measure: Correlation between CMD and E/e'
timeFrame: Immediate after the index procedure
measure: Correlation between CMD and HFA-PEFF score
timeFrame: Immediate after the index procedure
measure: Correlation between CMD and NT-proBNP
timeFrame: Immediate after the index procedure
measure: Correlation between CMD and pulmonary artery wedge pressure
timeFrame: Immediate after the index procedure
measure: Correlation between CMD and mean pulmonary artery pressure
timeFrame: Immediate after the index procedure
measure: All-cause death
timeFrame: At 2 years after the index procedure
measure: Cardiac death
timeFrame: At 2 years after the index procedure
measure: Myocardial infarction
timeFrame: At 2 years after the index procedure
measure: Any revascularization
timeFrame: At 2 years after the index procedure
measure: Readmission due to heart failure
timeFrame: At 2 years after the index procedure
measure: Readmission
timeFrame: At 2 years after the index procedure
measure: Proportion of heart failure with reduced ejection fraction
timeFrame: At 2 years after the index procedure
measure: Correlation between CMD and Excercise induced E/e'
timeFrame: Immediate after the index procedure
measure: Correlation between CMD and Exercise induced pulmonary artery wedge pressure
timeFrame: Immediate after the index procedure
measure: Correlation between CMD and exercise time
timeFrame: Immediate after the index procedure
measure: Correlation between CMD and mean exercise induced pulmonary artery pressure
timeFrame: Immediate after the index procedure
measure: Correlation between CMD and Gas analysis data (Peak exercise oxygen consumption, Respiratory quotient)
timeFrame: Immediate after the index procedure
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Ki Hong Choi, MD
role: PRINCIPAL_INVESTIGATOR
References: