Clinical trial NCT06927973: Leveraging Exercise Stress Echocardiography for Heart Failure With Preserved Ejection Fraction
Official title: Leveraging Exercise Stress Echocardiography for Heart Failure With Preserved Ejection Fraction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chest Pain
Shortness of Breath
Keywords: Stress echocardiogram
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2025-04-15
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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).


Eligibility criteria: 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

Primary outcomes:
measure: HFpEF clinic visit at 1 month and 6 months
timeFrame: Within 6 months of participant enrollment
measure: Confirmed HFpEF diagnosis at 1 month and 6 months
timeFrame: Within 6 months of participant enrollment
measure: Estimate the prevalence of undiagnosed HFpEF in patients undergoing exercise stress echo using HFpEF probability score and exercise echo filling pressure assessment
timeFrame: Within 6 months of participant enrollment
Secondary outcomes:
measure: Right heart catheterization (both resting and exercise) visit at 1 month and 6 months
timeFrame: Within 6 months of participant enrollment
measure: SGLT2 inhibitor use at baseline, months 1 and 6
timeFrame: Baseline at enrollment and 6 months post enrollment
measure: MRA Use at baseline, months 1 and 6
timeFrame: Baseline at enrollment and 6 months post enrollment
measure: GLP1 RA use at baseline, months 1 and 6
timeFrame: Baseline at enrollment and 6 months post enrollment
measure: Right heart catherization (both resting and exercise) referral at months 1 and 6
timeFrame: Within 6 months of participant enrollment
measure: HFpEF clinical referral at months 1 and 6
timeFrame: Within 6 months of participant enrollment
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Marat Fudim, MD
role: PRINCIPAL_INVESTIGATOR
References: