Leveraging Exercise Stress Echocardiography for Heart Failure With Preserved Ejection Fraction

Duke University30 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Chest Pain Shortness of Breath

Interventions

EchocardiogramDIAGNOSTIC_TEST

Ultrasound

Eligibility

Sex: ALLMin age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Duke University Medical Center

Durham, North Carolina, United States

Outcomes

Primary Outcomes

HFpEF clinic visit at 1 month and 6 months

Number of participants undergoing resting only or exercise right heart catheterization

Time frame: 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

Time frame: 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.

Time frame: Within 6 months of participant enrollment

Secondary Outcomes

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

Time frame: Within 6 months of participant enrollment

SGLT2 inhibitor use at baseline, months 1 and 6

Time frame: Baseline at enrollment and 6 months post enrollment

MRA Use at baseline, months 1 and 6

Time frame: Baseline at enrollment and 6 months post enrollment

GLP1 RA use at baseline, months 1 and 6

Data from ClinicalTrials.gov

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