Recruiting

Observational Study

Sponsor:

Johns Hopkins University

Code:

NCT06299436

Conditions

Heart Failure With Reduced Ejection Fraction

Pulmonary Hypertension

Right Heart Failure Due to Left Heart Failure

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

Right ventricular (RV) failure is recognized to worsen patient outcomes in the setting of heart failure with reduced ejection fraction (HFrEF)-related pulmonary hypertension (PH), yet the investigators fall short in trying to identify and treat it. The current proposal will (1) determine the best clinical indicators of intrinsic RV myocyte contractile failure in humans with HFrEF-PH, (2) clarify underlying mechanisms, and (3) test novel treatments on RV myocytes. The long-term goal of this proposal will be to better identify and treat RV failure in humans suffering from HFrEF-PH.

Conditions

Heart Failure With Reduced Ejection Fraction

Pulmonary Hypertension

Right Heart Failure Due to Left Heart Failure

Study ID

NCT06299436

Start date

Dec 10, 2024

Status verified date

Jan, 2026

Completion date

Mar 31, 2029

Anticipated

Primary completion date

Mar 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Diagnostic accuracy based on Area Under Curve (AUC) [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Steven Hsu, MD

410-502-0955steven.hsu@jhmi.edu

Locations

Johns Hopkins Hospital

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Wendy I Foy

410-955-8491wfoy2@jh.edu

steven.hsu@jhmi.edu

Principal Investigator:

Steven Hsu, MD

More Information

Sponsor

Johns Hopkins University

Last update posted

Jan 12, 2026

Last verified

Jan, 2026

Keywords

  • right heart failure
  • heart failure
  • cardiomyopathy
  • pulmonary hypertension
  • heart failure with reduced ejection fraction

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-08. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-01-12. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.