Leveraging Exercise Stress Echocardiography for Heart Failure With Preserved Ejection Fraction

Not Applicable

Not yet recruiting

• Conditions: Chest Pain; Shortness of Breath

• Registration Number: NCT06927973
• Lead Sponsor: Duke University

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-04-07
• Study First Submitted QC: 2025-04-07
• Study First Posted: 2025-04-15
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-15
• Study Start: 2025-06
• Primary Completion: 2026-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
HFpEF clinic visit at 1 month and 6 months	Within 6 months of participant enrollment	Number of participants undergoing resting only or exercise right heart catheterization
Confirmed HFpEF diagnosis at 1 month and 6 months	Within 6 months of participant enrollment	Number of participants being documented to have HFpEF diagnosis in Electronic Health Record
Estimate the prevalence of undiagnosed HFpEF in patients undergoing exercise stress echo using HFpEF probability score and exercise echo filling pressure assessment	Within 6 months of participant enrollment	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.

Secondary Outcome Measures

Name	Time	Method
SGLT2 inhibitor 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
Right heart catheterization (both resting and exercise) visit at 1 month and 6 months	Within 6 months of participant enrollment	Number of participants undergoing resting only or exercise right heart catheterization
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

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States