Chest Pain, Shortness of Breath
Conditions
Keywords
Stress echocardiogram
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).
Interventions
DIAGNOSTIC_TESTEchocardiogram
Ultrasound
Sponsors
Duke University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| GLP1 RA use at baseline, months 1 and 6 | Baseline at enrollment and 6 months post 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 |
| Right heart catherization (both resting and exercise) referral at months 1 and 6 | 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 | — |
Countries
United States
Outcome results
None listed