Assessing Cardiac Function in Heart Failure Patients
Myocardial Reserve in Advanced Heart Failure Patients
This study is testing if a heart medication called milrinone can improve heart function and outcomes for people with heart failure who need advanced treatments.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 5 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Chicago Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT05700617 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate whether differences in myocardial reserve can predict clinical outcomes in patients with heart failure. It is designed as a prospective, observational, crossover study that involves assessing invasive hemodynamics through right heart catheterization. Patients will be randomized to receive milrinone to determine its effects on cardiac function and outcomes. The study focuses on patients referred for advanced heart failure therapies or those with worsening clinical status requiring accurate hemodynamic assessment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a left ventricular ejection fraction (LVEF) of 40% or less who are referred for right heart catheterization.
Not a fit: Patients with severe, non-revascularized coronary artery disease or those with concurrent acute coronary syndrome may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the prediction of clinical outcomes for heart failure patients, leading to better-targeted therapies.
How similar studies have performed: Other studies have shown promise in using invasive hemodynamics to predict outcomes in heart failure, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. LVEF ≤ 40% 2. Referred for RHC for: 1. Evaluation for advanced heart failure therapies, including LVAD, OHT, temporary or long-term inotrope therapy, or counter-pulsation (temporary or long-term with NuPulse device OR 2. Accurate assessment of invasive hemodynamics due to worsening clinical status, OR 3. Assessment of myocardial recovery for consideration of LVAD or counter-pulsation (temporary IABP or long-term with NuPulse device) decommissioning or removal OR 4. Assessment of cardiac function and valvular abnormalities prior to planned valvular surgery for MR or AI 3. Estimated glomerular filtration rate (eGFR) ≥ 30 ml/min/1.73 m2 4. Age ≥ 18 years-old 5. Intent for admission based on RHC data Exclusion Criteria: 1. eGFR \< 30 ml/min/1.73 m2 2. Severe, non-revascularized coronary artery disease 3. Concurrent acute coronary syndrome 4. Age \< 18 years-old 5. History of significant ventricular arrhythmia without an ICD
Where this trial is running
Chicago, Illinois
- The University of Chicago — Chicago, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Valluvan Jeevanandam, MD — University of Chicago
- Study coordinator: David Onsager, MD
- Email: donsager1@uchgicagomedicine.org
- Phone: 7737021000
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.