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Leveraging Exercise Stress Echocardiography for Heart Failure With Preserved Ejection Fraction

NCT ID: NCT06927973

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-30

Study Completion Date

2025-12-19

Brief Summary

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The purpose of this study is to find out if additional images taken during a stress echocardiogram study and risk score calculation will help the doctor determine if shortness of breath or chest pain are caused by stiff heart (heart failure with preserved ejection fraction or HFpEF).

Detailed Description

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Conditions

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Chest Pain Shortness of Breath

Keywords

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Stress echocardiogram

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Enrolled subjects undergoing clinical stress echocardiogram

The enrolled subject will undergo their clinically indicated stress echocardiogram study for chest pain or shortness of breath. At the conclusion of the clinical study 4 additional echo images will be obtained for research purposes.

Group Type EXPERIMENTAL

Echocardiogram

Intervention Type DIAGNOSTIC_TEST

Ultrasound

Interventions

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Echocardiogram

Ultrasound

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Clinically indicated exercise stress echo for the evaluation of exertional dyspnea or chest pain
* Age ≥50 years

Exclusion Criteria

* Known history of HFpEF
* LVEF \<50% on baseline echo study
* History of hypertrophic cardiomyopathy, amyloidosis, or pulmonary arterial hypertension, severe right ventricular dysfunction and severe valvular disease based on chart review or baseline echo study
* History of organ transplant (heart, kidney, liver, lungs)
* Severe pulmonary disease requiring ambulatory oxygen therapy
* End-stage renal disease requiring long-term renal replacement therapy
* Decompensated liver disease
* Conditions that prevent accurate assessment of E/e' ratio (mitral prosthetic valve, severe mitral annular calcification)
* Plan to use echo contrast agent during stress study (i.e. contrast agent needed for baseline study)
* Patients from outside Duke health system with no plan for long-term care at Duke
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marat Fudim, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Duke University Medical Center

Durham, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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Pro00117015

Identifier Type: -

Identifier Source: org_study_id