Hemodynamic Assessment of underLying myocyTe Function in Right Heart Failure

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorJohns Hopkins University

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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.

Time frame
5 years

Secondary outcomes

1

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.

Time frame
5 years
2

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.

Time frame
5 years

Other outcomes

Sponsors and contacts

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Johns Hopkins University

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator