Leveraging Exercise Stress Echocardiography for Heart Failure With Preserved Ejection Fraction

NCT06927973 | Completed

• 1 other identifier: Pro00117015
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Chest Pain; Shortness of Breath

Keywords

Stress echocardiogram

Outcome Measures

Primary Outcomes (3)

• HFpEF clinic visit at 1 month and 6 months

  Number of participants undergoing resting only or exercise right heart catheterization

  Within 6 months of participant enrollment

• Confirmed HFpEF diagnosis at 1 month and 6 months

  Number of participants being documented to have HFpEF diagnosis in Electronic Health Record

  Within 6 months of participant enrollment

• Estimate the prevalence of undiagnosed HFpEF in patients undergoing exercise stress echo using HFpEF probability score and exercise echo filling pressure assessment

  Participants are presumed to have undiagnosed HFpEF using these following definitions: 1. Participants with H2FPEF score ≥6 2. Participants with elevated exercise echo filling pressure 3. Participants with H2FPEF score ≥6 or elevated exercise echo filling pressure The difference in undiagnosed HFpEF prevalence between definition #1 and #3 will inform the incremental diagnostic value of exercise echo filling pressure assessment.

  Within 6 months of participant enrollment

Secondary Outcomes (6)

• Right heart catheterization (both resting and exercise) visit at 1 month and 6 months

  Within 6 months of participant enrollment

• SGLT2 inhibitor use at baseline, months 1 and 6

  Baseline at enrollment and 6 months post enrollment

• MRA Use at baseline, months 1 and 6

  Baseline at enrollment and 6 months post enrollment

• GLP1 RA use at baseline, months 1 and 6

  Baseline at enrollment and 6 months post enrollment

• Right heart catherization (both resting and exercise) referral at months 1 and 6

  Within 6 months of participant enrollment

Study Arms (1)

Enrolled subjects undergoing clinical stress echocardiogram

EXPERIMENTAL

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.

Diagnostic Test: Echocardiogram

Interventions

Echocardiogram DIAGNOSTIC_TEST

Ultrasound

Enrolled subjects undergoing clinical stress echocardiogram

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Chest Pain; Dyspnea

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Officials

• Marat Fudim, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: April 15, 2025
• Study Start: May 30, 2025
• Primary Completion: December 19, 2025
• Study Completion: December 19, 2025
• Last Updated: December 23, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)