UnknownNot Applicable

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

South Korea100 participantsStarted 2021-01-25

Plain-language 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.

Who can participate

Age range

19 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Proportion of CMD in patients with HFpEF

Timeframe: Immediate after the index procedure

Trial details

NCT IDNCT04788576

SponsorSamsung Medical Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-09-30

Contact for this trial

Ki Hong Choi, MD

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

View on ClinicalTrials.gov More Heart Failure With Preserved Ejection Fraction trials

Who can participate

Age range

19 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.