NCT04788576

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 25, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 5, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 9, 2021

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

January 30, 2024

Status Verified

January 1, 2024

Enrollment Period

3.7 years

First QC Date

March 5, 2021

Last Update Submit

January 28, 2024

Conditions

Heart Failure With Preserved Ejection FractionCoronary Microvascular Dysfunction

Keywords

Heart failure with preserved ejection fractionCoronary physiologyCoronary microvascular dysfunctionHFA-PEFF score

Outcome Measures

Primary Outcomes (1)

  • Proportion of CMD in patients with HFpEF

    Proportion of CMD confirmed by invasive physiologic evaluation

    Immediate after the index procedure

Secondary Outcomes (18)

  • Correlation between CMD and left ventricular end diastolic pressure

    Immediate after the index procedure

  • Correlation between CMD and E/e'

    Immediate after the index procedure

  • 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 pulmonary artery wedge pressure

    Immediate after the index procedure

  • +13 more secondary outcomes

Study Arms (1)

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)

Diagnostic Test: Invasive physiologic evaluation (fractional flow reserve, coronary flow reserve, index of microcirculatory resistance)

Interventions

Invasive physiologic evaluation (fractional flow reserve, coronary flow reserve, index of microcirculatory resistance)DIAGNOSTIC_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.

Patients with heart failure with preserved ejection fraction (HFpEF)

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

Study Officials

  • Ki Hong Choi, MD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ki Hong Choi, MD

CONTACT

82-2-3410-1246cardiokh@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

March 5, 2021

First Posted

March 9, 2021

Study Start

January 25, 2021

Primary Completion

September 30, 2024

Study Completion

December 31, 2024

Last Updated

January 30, 2024

Record last verified: 2024-01

Locations

KR(1)