Leveraging Exercise Stress Echocardiography for Heart Failure With Preserved Ejection Fraction

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).

Study Overview

• Status: Completed
• Conditions: Chest Pain; Shortness of Breath
• Intervention / Treatment: Diagnostic test: Echocardiogram

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Diagnostic test: Echocardiogram; Ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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: Participants with H2FPEF score ≥6; Participants with elevated exercise echo filling pressure; 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Right heart catheterization (both resting and exercise) visit at 1 month and 6 months	Number of participants undergoing resting only or exercise right heart catheterization	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
HFpEF clinical referral at months 1 and 6		Within 6 months of participant enrollment

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Marat Fudim, MD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2025
• Primary Completion (Actual): December 19, 2025
• Study Completion (Actual): December 19, 2025

Study Registration Dates

• First Submitted: April 7, 2025
• First Submitted That Met QC Criteria: April 7, 2025
• First Posted (Actual): April 15, 2025

Study Record Updates

• Last Update Posted (Actual): December 23, 2025
• Last Update Submitted That Met QC Criteria: December 19, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Stress echocardiogram
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Dyspnea; Chest Pain; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Imaging; Diagnostic Techniques, Cardiovascular; Heart Function Tests; Cardiac Imaging Techniques; Ultrasonography; Echocardiography
• Other Study ID Numbers: Pro00117015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No