Echocardiogram for Heart Failure

Overseen By Mark Kittipibul, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: HfpEF, LVEF <50%, organ transplant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 1 day

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if taking additional images during a stress echocardiogram (a heart ultrasound performed during exercise) can help doctors identify whether symptoms like shortness of breath or chest pain result from a stiff heart. The focus is on heart failure with preserved ejection fraction (HFpEF), where the heart pumps effectively but is too stiff to fill properly. Eligible participants are those needing a stress echo to evaluate chest pain or breathlessness and who do not have certain heart or lung conditions. This trial is open to individuals within the Duke health system who plan to remain for long-term care. As an unphased trial, it offers a unique opportunity to contribute to understanding HFpEF and improve future patient care.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this echocardiogram technique is safe?

Research shows that exercise stress echocardiography is generally safe for patients. Studies have found a low risk of serious, life-threatening events during these tests. In one study, patients with normal test results experienced no heart attacks or new cases of heart failure, indicating that the test did not cause serious heart problems in those cases.

Overall, exercise stress echocardiography helps doctors assess heart function and blood flow without posing significant risks to patients. While no test is entirely risk-free, available research suggests this one is well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Exercise Stress Echocardiography for heart failure because it provides a dynamic assessment of heart function that can reveal issues not seen at rest. Unlike standard echocardiograms, which are typically done while the patient is at rest, this method captures how the heart performs under physical stress, potentially offering more detailed insights into conditions like chest pain or shortness of breath. Additionally, the ability to gather extra echocardiographic images for research purposes could lead to improved diagnostic techniques and treatments in the future.

What evidence suggests that this echocardiogram is effective for diagnosing heart failure?

Research has shown that exercise stress echocardiography, which uses heart images during exercise, can help diagnose heart failure with preserved ejection fraction (HFpEF). Studies have found that certain heart images taken during exercise relate to the progression of HFpEF, aiding in predicting the condition's future. This test is particularly useful for identifying heart problems like diastolic heart failure, where the heart struggles to relax and fill with blood. It can also determine the cause of unexplained shortness of breath by assessing heart function under stress. Overall, these findings suggest that stress echocardiography could effectively identify and manage heart issues related to HFpEF. Participants in this trial will undergo a clinically indicated stress echocardiogram, with additional images taken for research purposes. ^{5 6 7 8 9}

Who Is on the Research Team?

Marat Fudim, MD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for people over 50 who are getting a stress echocardiogram because they have trouble breathing or chest pain when active. It's not for those with known stiff heart issues, weak heart pump, severe kidney disease, certain lung conditions, specific heart diseases like hypertrophic cardiomyopathy or severe valve problems.

Inclusion Criteria

Clinically indicated exercise stress echo for the evaluation of exertional dyspnea or chest pain

I am 50 years old or older.

Exclusion Criteria

LVEF <50% on baseline echo study

I have been diagnosed with heart failure with preserved ejection fraction.

I am on long-term dialysis for kidney failure.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a clinically indicated stress echocardiogram study with additional echo images taken for research purposes

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including HFpEF clinic visits and right heart catheterization

6 months

2 visits (in-person) at 1 month and 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Exercise Stress Echocardiography

Trial Overview The study tests if extra images and risk scores from a stress echocardiogram can help doctors figure out if breathlessness or chest pain is due to a stiff heart (HFpEF).

How Is the Trial Designed?

Group I: Enrolled subjects undergoing clinical stress echocardiogram Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8950754/

Exercise Stress Echocardiography in the Diagnostic ... Echocardiographic markers of congestion during exercise are associated with clinical outcomes in HFpEF, supporting the prognostic value of ...

2. academic.oup.com academic.oup.com/ehjcimaging/article/26/2/187/7896313

Long-term outcomes after stress echocardiography in real ... A positive stress echocardiogram was associated with a greater risk of myocardial infarction [HR 2.71, 95% confidence interval (CI) 1.73–4.24, P < 0.001] and a ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0167527322013912

Impact of training on combined cardiopulmonary exercise ... This study suggests that combining CPET and a stress echocardiography may be a useful method for the assessment of CHF severity, as well as the ...

4. asecho.org asecho.org/wp-content/uploads/2020/01/Stress-Echo-2020.pdf

Stress-Echo-2020.pdf Assessment of diastolic function with stress may be beneficial in the evaluation of patients with unexplained dyspnea using the combination of Doppler.

5. link.springer.com link.springer.com/article/10.1007/s10741-024-10423-9

Stress echocardiography in heart failure patients Stress echocardiography (SE) has recently shown its unique value for the evaluation of diastolic heart failure, VHD, non-ischemic cardiomyopathies and ...

6. my.clevelandclinic.org my.clevelandclinic.org/health/diagnostics/16984-exercise-stress-test

Stress Test: Purpose, Procedure, Risks and Results An exercise stress test evaluates heart pumping capabilities and blood flow. There are different types, including stress echocardiogram and nuclear stress ...

7. aafp.org aafp.org/pubs/afp/issues/2017/0901/p293.html

Exercise Stress Testing: Indications and Common Questions A 2012 systematic review of 34 prospective studies found that exercise stress testing and stress echocardiography were better at excluding CAD ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5358292/

Long Term Outcomes in Stress Echocardiography There were no myocardial infarctions or new diagnoses of heart failure in the negative echocardiogram group. There were seven deaths in the total population and ...

9. frontiersin.org frontiersin.org/journals/cardiovascular-medicine/articles/10.3389/fcvm.2023.1228613/full

Complications of exercise and pharmacologic stress ... Overall, the risk of major, life-threatening adverse patient outcomes with both exercise and pharmacologic echocardiographic stress testing is ...