Nutritional support for heart failure patients undergoing LVAD placement
Enhanced Nutritional Optimization in LVAD (ENOL) Trial
NA · Columbia University · NCT05655910
This study tests if giving heart failure patients a special nutritional shake before their LVAD surgery can help them recover better and avoid complications.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Columbia University (other) |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT05655910 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effects of a nutritional immune modulating intervention using Ensure Surgery Immunonutrition shake on heart failure patients awaiting left ventricular assist device (LVAD) implantation. The study aims to determine if pre-surgical supplementation can improve gut microbiome composition, reduce systemic inflammation, and decrease post-surgical complications such as infections and length of ICU stay. Participants will be assessed for malnutrition and provided with the nutritional shake in the days leading up to their surgery.
Who should consider this trial
Good fit: Ideal candidates are hospitalized adults over 18 years old who are scheduled for LVAD therapy.
Not a fit: Patients who are intubated, have congenital heart disease, or cannot tolerate oral nutrition may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could improve recovery outcomes and reduce complications for heart failure patients undergoing LVAD implantation.
How similar studies have performed: Other studies have shown promising results with nutritional interventions in similar patient populations, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * age \>18 years * hospitalized * undergoing LVAD therapy (enrolled at time of acceptance) Exclusion Criteria: * intubated * congenital heart disease * infiltrative cardiomyopathy * unable to tolerate oral nutrition * surgery expected in \<5 days
Where this trial is running
New York, New York
- Columbia University Medical Center — New York, New York, United States (RECRUITING)
Study contacts
- Principal investigator: Melana Yuzefpolskaya, MD — Columbia University
- Study coordinator: Melana Yuzefpolskaya, MD
- Email: my2249@cumc.columbia.edu
- Phone: 3472681454
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.
Conditions: Heart Failure, Gut Microbiome, Nutritional Deficiency, Left Ventricular Assist Device, Advanced Heart Failure, Mechanical Circulatory Support, Infection