Chest PainNCT06927973
Leveraging Exercise Stress Echocardiography for Heart Failure With Preserved Ejection Fraction
A study testing Echocardiogram in people with Chest Pain and Shortness of Breath, run by Duke University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chest Pain, Shortness of Breath
- What is being tested?
- Echocardiogram
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 30 May 2025to 19 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinically indicated exercise stress echo for the evaluation of exertional dyspnea or chest pain
- Age ≥50 years
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
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).
- Conditions
- Chest Pain, Shortness of Breath
- Being tested
- Echocardiogram
- Keywords
- Stress echocardiogram
- Medical subject headings
- Chest Pain, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchocardiogramDiagnostic test
Ultrasound
| Study group | Role | What they receive |
|---|---|---|
| Enrolled subjects undergoing clinical stress echocardiogram | Experimental | The enrolled subject will undergo their clinically indicated stress echocardiogram study for chest pain or shortness of breath. At the conclusion of the clinical study 4 additional echo images will be obtained for research purposes. Receives: Diagnostic Test: Echocardiogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
HFpEF clinic visit at 1 month and 6 months
Number of participants undergoing resting only or exercise right heart catheterization
Measured: 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
Measured: 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:
- 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.
Measured: Within 6 months of participant enrollment
Secondary outcomes (6)
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
Measured: Within 6 months of participant enrollment
SGLT2 inhibitor use at baseline, months 1 and 6
Measured: Baseline at enrollment and 6 months post enrollment
MRA Use at baseline, months 1 and 6
Measured: Baseline at enrollment and 6 months post enrollment
GLP1 RA use at baseline, months 1 and 6
Measured: Baseline at enrollment and 6 months post enrollment
Right heart catherization (both resting and exercise) referral at months 1 and 6
Measured: Within 6 months of participant enrollment
HFpEF clinical referral at months 1 and 6
Measured: Within 6 months of participant enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start30 May 2025
- Primary completion19 Dec 2025
- Study completion19 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chest PainStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marat Fudim, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06927973
- Sponsor's protocol ID
- Pro00117015
- Status last verified
- Feb 2025
- First submitted
- 7 Apr 2025
- Last updated
- 23 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leveraging Exercise Stress Echocardiography for Heart Failure With Preserved Ejection Fraction
- ClinicalTrials.gov ID
- NCT06927973
- Acronym / sponsor ID
- Pro00117015
- Conditions
- Chest Pain, Shortness of Breath
- Keywords
- Stress echocardiogram
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 30 May 2025 (actual)
- Primary completion
- 19 Dec 2025 (actual)
- Study completion
- 19 Dec 2025 (actual)
- First posted
- 15 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Enrolled subjects undergoing clinical stress echocardiogram | Experimental | Diagnostic Test: EchocardiogramThe enrolled subject will undergo their clinically indicated stress echocardiogram study for chest pain or shortness of breath. At the conclusion of the clinical study 4 additional echo images will be obtained for research purposes. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinically indicated exercise stress echo for the evaluation of exertional dyspnea or chest pain
- Age ≥50 years
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EchocardiogramUltrasound | Diagnostic test | Enrolled subjects undergoing clinical stress echocardiogram |
Primary outcome
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
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
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: 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.
6 secondary outcomes
Right heart catheterization (both resting and exercise) visit at 1 month and 6 months
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
Time frame: Baseline at enrollment and 6 months post enrollment
Right heart catherization (both resting and exercise) referral at months 1 and 6
Time frame: Within 6 months of participant enrollment
HFpEF clinical referral at months 1 and 6
Time frame: Within 6 months of participant enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marat Fudim, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Echocardiogram in people with Chest Pain and Shortness of Breath, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HFpEF clinic visit at 1 month and 6 months (time frame: Within 6 months of participant enrollment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.