- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04788576
Distribution and Clinical Implication of CMD in Patients With HFpEF Without Significant CAD (HFpEF-CMD)
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 Overview
Status
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Ki Hong Choi, MD
- Phone Number: 82-2-3410-1246
- Email: cardiokh@gmail.com
Study Locations
-
-
-
Seoul, Korea, Republic of, 06351
- Recruiting
- Samsung Medical Center
-
Contact:
- Ki Hong Choi, MD
- Phone Number: 82-2-3410-3419
- Email: cardiokh@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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)
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of CMD in patients with HFpEF
Time Frame: Immediate after the index procedure
|
Proportion of CMD confirmed by invasive physiologic evaluation
|
Immediate after the index procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Immediate after the index procedure
|
Correlation between CMD and E/e'
Time Frame: Immediate after the index procedure
|
Correlation between CMD confirmed by invasive physiologic evaluation and E/e'
|
Immediate after the index procedure
|
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
|
Immediate after the index procedure
|
Correlation between CMD and NT-proBNP
Time Frame: Immediate after the index procedure
|
Correlation between CMD confirmed by invasive physiologic evaluation and NT-proBNP
|
Immediate after the index procedure
|
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
|
Immediate after the index procedure
|
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
|
Immediate after the index procedure
|
All-cause death
Time Frame: At 2 years after the index procedure
|
All-cause death during follow-up
|
At 2 years after the index procedure
|
Cardiac death
Time Frame: At 2 years after the index procedure
|
Cardiac death during follow-up
|
At 2 years after the index procedure
|
Myocardial infarction
Time Frame: At 2 years after the index procedure
|
Myocardial infarction during follow-up
|
At 2 years after the index procedure
|
Any revascularization
Time Frame: At 2 years after the index procedure
|
Any revascularization during follow-up
|
At 2 years after the index procedure
|
Readmission due to heart failure
Time Frame: At 2 years after the index procedure
|
Readmission due to heart failure during follow-up
|
At 2 years after the index procedure
|
Readmission
Time Frame: At 2 years after the index procedure
|
Readmission during follow-up
|
At 2 years after the index procedure
|
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
|
At 2 years after the index procedure
|
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'
|
Immediate after the index procedure
|
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
|
Immediate after the index procedure
|
Correlation between CMD and exercise time
Time Frame: Immediate after the index procedure
|
Correlation between CMD confirmed by invasive physiologic evaluation exercise time
|
Immediate after the index procedure
|
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
|
Immediate after the index procedure
|
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
|
Immediate after the index procedure
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ki Hong Choi, MD, Samsung Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HFpEF_CMD
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Heart Failure With Preserved Ejection Fraction
-
University Hospital, AkershusNovartisActive, not recruitingHeart Failure | Heart Failure With Reduced Ejection Fraction | Heart Failure With Preserved Ejection FractionNorway
-
University of SienaEuropean Association of Cardiovascular ImagingActive, not recruitingHeart Failure | Heart Failure With Reduced Ejection Fraction | Heart Failure With Preserved Ejection Fraction | Heart Failure With Mid Range Ejection FractionSpain, Greece, Turkey, Portugal, Australia, Belgium, Italy, Mexico, Netherlands, North Macedonia, Romania, Tunisia
-
Istituti Clinici Scientifici Maugeri SpARecruitingHeart Failure With Preserved Ejection Fraction | Heart Failure With Midrange Ejection FractionItaly
-
Milton S. Hershey Medical CenterWithdrawnHeart Failure | Heart Failure With Reduced Ejection Fraction | Heart Failure With Preserved Ejection FractionUnited States
-
Board of Trustees of Illinois State UniversityUniversity of Colorado, Denver; Abbott; University of North Carolina, Greensboro and other collaboratorsRecruitingHeart Failure | Heart Failure With Reduced Ejection Fraction | Heart Failure With Preserved Ejection FractionUnited States
-
Milton S. Hershey Medical CenterCompletedHeart Failure | Heart Failure With Reduced Ejection Fraction | Heart Failure With Preserved Ejection FractionUnited States
-
Zhijun SunEnrolling by invitationHeart Failure | Heart Failure With Preserved Ejection Fraction | Heart Failure With Mid Range Ejection FractionChina
-
Corvia MedicalWithdrawnHeart Failure With Preserved Ejection Fraction | Heart Failure With Mid Range Ejection Fraction
-
Occlutech International ABActive, not recruitingHeart Failure With Preserved Ejection Fraction (HFpEF) | Heart Failure With Reduced Ejection Fraction (HFrEF)United States
-
Yale UniversityRecruitingHeart Failure | Heart Failure With Reduced Ejection Fraction | Heart Failure With Preserved Ejection Fraction | Heart Failure NYHA Class IVUnited States
Clinical Trials on Invasive physiologic evaluation (fractional flow reserve, coronary flow reserve, index of microcirculatory resistance)
-
Seoul National University HospitalSamsung Medical Center; Ulsan University Hospital; Inje University; Keimyung University... and other collaboratorsCompletedStable Angina | ST-segment Elevation Myocardial Infarction | Unstable Angina | Non-ST Elevation Myocardial InfarctionKorea, Republic of, Japan, Spain
-
Parc de Salut MarActive, not recruitingChronic Total Occlusion of Coronary Artery | Coronary; Ischemic | Coronary Microvascular Dysfunction | Microvascular Coronary Artery DiseaseSpain
-
Italo PortoAstraZenecaCompletedMyocardial IschemiaItaly
-
Onze Lieve Vrouw HospitalCentro Cardiologico MonzinoCompleted
-
Samsung Medical CenterChonnam National University Hospital; Chosun University Hospital; Gangneung Asan...Active, not recruitingIschemic Heart Disease | Heart Failure With Preserved Ejection Fraction | Microvascular Coronary Artery Disease | Diastolic DysfunctionKorea, Republic of, United States
-
Peking University First HospitalRainmed Ltd., Suzhou, ChinaRecruitingCoronary Artery Disease | Percutaneous Coronary Intervention | Stable Angina Pectoris | Unstable Angina Pectoris | Coronary Stenosis | Acute Myocardial Infarction | Myocardial Ischaemia | Coronary Circulation | Asymptomatic IschemiaChina
-
Academisch Medisch Centrum - Universiteit van Amsterdam...Samsung Medical Center; Aarhus University Hospital; Seoul National University... and other collaboratorsCompletedCoronary Artery Disease | Microvascular Coronary Artery DiseaseKorea, Republic of, Denmark, Spain, Netherlands, Japan, United States, Italy
-
HeartFlow, Inc.Case Western Reserve UniversityCompletedCoronary Artery DiseaseDenmark
-
Seoul National University HospitalInje University; Keimyung University Dongsan Medical Center; Tsuchiura Kyodo...CompletedCoronary Artery Disease
-
Samsung Medical CenterSeoul National University Hospital; Ulsan University Hospital; Keimyung University... and other collaboratorsCompletedIschemic Heart DiseaseKorea, Republic of