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

Heart Failure With Preserved Ejection Fraction Clinical Trial

— HFpEF-CMD  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04788576
• Other study ID #: HFpEF_CMD
• Status: Recruiting
• Start date: January 25, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: Samsung Medical Center
• Contact: Ki Hong Choi, MD
• Phone: 82-2-3410-1246
• Email: cardiokh[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Microvascular Dysfunction
• Heart Failure
• Heart Failure With Preserved Ejection Fraction

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of CMD in patients with HFpEF	Proportion of CMD confirmed by invasive physiologic evaluation	Immediate after the index procedure
Secondary	Correlation between CMD and left ventricular end diastolic pressure	Correlation between CMD confirmed by invasive physiologic evaluation and left ventricular end diastolic pressure	Immediate after the index procedure
Secondary	Correlation between CMD and E/e'	Correlation between CMD confirmed by invasive physiologic evaluation and E/e'	Immediate after the index procedure
Secondary	Correlation between CMD and HFA-PEFF score	Correlation between CMD confirmed by invasive physiologic evaluation and HFA-PEFF score	Immediate after the index procedure
Secondary	Correlation between CMD and NT-proBNP	Correlation between CMD confirmed by invasive physiologic evaluation and NT-proBNP	Immediate after the index procedure
Secondary	Correlation between CMD and pulmonary artery wedge pressure	Correlation between CMD confirmed by invasive physiologic evaluation and pulmonary artery wedge pressure	Immediate after the index procedure
Secondary	Correlation between CMD and mean pulmonary artery pressure	Correlation between CMD confirmed by invasive physiologic evaluation and mean pulmonary artery pressure	Immediate after the index procedure
Secondary	All-cause death	All-cause death during follow-up	At 2 years after the index procedure
Secondary	Cardiac death	Cardiac death during follow-up	At 2 years after the index procedure
Secondary	Myocardial infarction	Myocardial infarction during follow-up	At 2 years after the index procedure
Secondary	Any revascularization	Any revascularization during follow-up	At 2 years after the index procedure
Secondary	Readmission due to heart failure	Readmission due to heart failure during follow-up	At 2 years after the index procedure
Secondary	Readmission	Readmission during follow-up	At 2 years after the index procedure
Secondary	Proportion of heart failure with reduced ejection fraction	Proportion of progression of heart failure with reduced ejection fraction	At 2 years after the index procedure
Secondary	Correlation between CMD and Excercise induced E/e'	Correlation between CMD confirmed by invasive physiologic evaluation and exercise induced E/e'	Immediate after the index procedure
Secondary	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	Immediate after the index procedure
Secondary	Correlation between CMD and exercise time	Correlation between CMD confirmed by invasive physiologic evaluation exercise time	Immediate after the index procedure
Secondary	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	Immediate after the index procedure
Secondary	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	Immediate after the index procedure