Assessing heart function in patients with right heart failure
Hemodynamic Assessment of underLying myocyTe Function in Right Heart Failure
This study is trying to find better ways to spot and treat right heart problems in people with heart failure and high blood pressure in the lungs by looking at how their heart functions during exercise.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT06299436 on ClinicalTrials.gov |
What this trial studies
This observational study aims to improve the understanding and diagnosis of right ventricular (RV) myocyte dysfunction in patients suffering from heart failure with reduced ejection fraction and pulmonary hypertension (HFrEF-PH). The investigators will identify clinical indicators of RV myocyte contractile failure and explore underlying mechanisms. By measuring RV contractile reserve during exercise, the study seeks to provide insights that could lead to better prognostic and therapeutic strategies for RV failure. The ultimate goal is to enhance the identification and treatment of RV dysfunction in earlier stages of heart failure.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 90 diagnosed with heart failure with reduced ejection fraction.
Not a fit: Patients who are unable to interrupt anticoagulation therapy or those with acute hospitalization or decompensation within two weeks prior to the study may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnosis and treatment options for patients with right heart failure, potentially enhancing their outcomes.
How similar studies have performed: While this approach is novel in its focus on early-stage RV dysfunction, previous studies have shown the importance of RV myocyte function in heart failure outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients aged between 18 and 90 years of age * Diagnosed with heart failure with reduced ejection fraction (LV ejection fraction ≤ 40-50%) * Can safely hold direct oral anticoagulant (DOAC) vitamin K antagonist (VKA) for 48 hours prior to the procedure Exclusion Criteria: * Unable to interrupt VKA anticoagulation * Point of care International Normalized Ratio (INR) \> 1.5 * Pregnant patients * Acute hospitalization or decompensation within 2 weeks prior to study date * Participation in a study involving an investigational drug within 4 weeks prior to study date * Inability to lie flat in the supine position * Symptomatic hemodynamic instability at rest or during the procedure
Where this trial is running
Baltimore, Maryland
- Johns Hopkins Hospital — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Steven Hsu, MD — Johns Hopkins School of Medicine
- Study coordinator: Steven Hsu, MD
- Email: steven.hsu@jhmi.edu
- Phone: 410-502-0955
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.