RightFit
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Hemodynamic Assessment of underLying myocyTe Function in Right Heart Failure

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 90 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Mentioned in the study description

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Biopsies

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "RV endomyocardial biopsies are obtained, and isolated myocytes permeabilized to assess contractile mechanics and calcium- and length-activated tension."
Compensation
Mentioned in the study description
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at why muscle cells on the right side of the heart become weak and tests new treatments on these cells. It is for adults with heart failure, where the heart pumps less blood than normal, and related high blood pressure in the lungs. The goal is to find better ways to spot and treat right-sided heart failure.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18 to 90 years old.
  • You have heart failure with reduced pumping strength. Your left heart pumping measure, called ejection fraction, is at or below 40–50%.
  • You can safely stop blood thinners called DOACs or VKAs for 48 hours before the procedure.

Who can't join

  • You cannot stop taking a VKA blood thinner.
  • Your INR, a blood test that measures how long blood takes to clot, is above 1.5.
  • You are pregnant.
  • You were hospitalized for a sudden illness or had a worsening of your condition within 2 weeks before the study date.
  • You took part in a study testing an experimental drug within 4 weeks before the study date.
  • You cannot lie flat on your back.
  • You have unstable blood flow or blood pressure that causes symptoms while resting or during the procedure.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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

Study sites (1)

MD