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

Trial Summary

What is the purpose of this trial?

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).

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 data supports the effectiveness of the treatment Exercise Stress Echocardiography for heart failure?

Stress echocardiography is effective in identifying heart problems by showing how the heart works under stress, which can help predict outcomes in heart failure. It is also useful in detecting coronary artery disease and assessing heart function after a heart attack, making it a valuable tool for managing heart conditions. ^{1 2 3 4 5}

Is stress echocardiography safe for humans?

Stress echocardiography, including exercise and pharmacologic methods, is generally safe with a low risk of major, life-threatening complications. However, adverse events are more common with dobutamine stress echocardiography, and precautions can minimize infectious risks, especially during pandemics. ^{6 7 8 9 10}

How is the treatment Exercise Stress Echocardiography unique for heart failure?

Exercise Stress Echocardiography is unique because it combines physical exercise with echocardiographic imaging to assess heart function, providing real-time visualization of heart motion during stress. This approach can detect abnormalities that might not be visible at rest, offering a more dynamic assessment compared to traditional methods. ^{5 11 12 13 14}

Research Team

Marat Fudim, MD

Principal Investigator

Duke University

Eligibility Criteria

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

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

LVEF <50% on baseline echo study

I am on long-term dialysis for kidney failure.

Timeline

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

Treatment Details

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).

Participant Groups

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+

References

1. Italy pubmed.ncbi.nlm.nih.gov

[Recent advances in the prognostic evaluation of non-ischemic dilated cardiomyopathy]. [2016]

2. England pubmed.ncbi.nlm.nih.gov

Outcomes of patients with reduced exercise capacity at time of exercise echocardiography. [2016]

3. United States pubmed.ncbi.nlm.nih.gov

Prognostic value of stress echocardiography in stable angina or after myocardial infarction. [2019]

4. Ireland pubmed.ncbi.nlm.nih.gov

Relative diagnostic, prognostic and economic value of stress echocardiography versus exercise electrocardiography as initial investigation for the detection of coronary artery disease in patients with new onset suspected angina. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Stress echocardiography for detection of coronary artery disease. [2015]

6. England pubmed.ncbi.nlm.nih.gov

Stress echocardiography: safety and tolerability. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Complications of exercise and pharmacologic stress echocardiography. [2023]

8. Spain pubmed.ncbi.nlm.nih.gov

[Evaluation of the safety of stress echocardiography in Spain and Portugal]. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Evolution of dobutamine echocardiography protocols and indications: safety and side effects in 3,011 studies over 5 years. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Safety of contrast agent use during stress echocardiography: a 4-year experience from a single-center cohort study of 26,774 patients. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Clinical applications of exercise stress echocardiography in the treadmill with upright evaluation during and after exercise. [2023]

12. Portugal pubmed.ncbi.nlm.nih.gov

Atropine in exercise stress echocardiography? Case report. [2015]

13. United States pubmed.ncbi.nlm.nih.gov

Exercise echocardiography. [2021]

14. United States pubmed.ncbi.nlm.nih.gov

Stress echocardiography in the evaluation of chest pain and accuracy in the diagnosis of coronary artery disease. [2019]