About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
The study population will include patients who have heart failure with reduced ejection fraction, defined by a left ventricular ejection fraction less than or equal to 40-50%.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Diagnostic accuracy based on Area Under Curve (AUC)
Diagnostic accuracy (AUC), as determined by combination of sensitivity and specificity, of multiple clinical metrics will be compared to determine which best identifies underlying right ventricular myocyte contractile dysfunction.
Secondary outcomes
Percentage improvement in ex vivo right ventricular tissue sample
Percentage improvement is defined as the percent difference in ex vivo right ventricular tissue sample myocyte contractility before and after experimental exposure to sarcomere-activating agent. Note this testing occurs on tissue samples, not in human subjects.
Predictive capacity (based on likelihood ratio)
Combining primary and secondary outcomes, the predictive capacity of clinical metrics will be determined for anticipating a response to sarcomere-activating agent.
Sponsors and contacts
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Johns Hopkins University
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator