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Completed

NCT Number: NCT06927973

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).

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Key information

Conditions

Chest Pain Dyspnea Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Shortness of Breath Signs and Symptoms Signs and Symptoms, Respiratory

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Echocardiogram

Diagnostic Test

Ultrasound

Primary outcomes

  1. HFpEF clinic visit at 1 month and 6 months

    Time frame: Within 6 months of participant enrollment

    Number of participants undergoing resting only or exercise right heart catheterization

  2. Confirmed HFpEF diagnosis at 1 month and 6 months

    Time frame: Within 6 months of participant enrollment

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

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

    Time frame: Within 6 months of participant enrollment

    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.

Secondary outcomes

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

    Time frame: Within 6 months of participant enrollment

    Number of participants undergoing resting only or exercise right heart catheterization

  2. SGLT2 inhibitor use at baseline, months 1 and 6

    Time frame: Baseline at enrollment and 6 months post enrollment

  3. MRA Use at baseline, months 1 and 6

    Time frame: Baseline at enrollment and 6 months post enrollment

  4. GLP1 RA use at baseline, months 1 and 6

    Time frame: Baseline at enrollment and 6 months post enrollment

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

    Time frame: Within 6 months of participant enrollment

  6. HFpEF clinical referral at months 1 and 6

    Time frame: Within 6 months of participant enrollment

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 15, 2025
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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