Global Public Health Burden of Heart Failure.
Gianluigi Savarese, Lars H Lund
https://pubmed.ncbi.nlm.nih.gov/28785469Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID05655910
Enhanced Nutritional Optimization in LVAD (ENOL) Trial
Led by Columbia University · Updated on 2025-10-31
50
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
Sponsors
C
Columbia University
Lead Sponsor
A
Abbott Nutrition
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of a nutritional immune modulating intervention, the Ensure Surgery Immunonutrition shake, on patients with advanced heart failure who are awaiting left ventricular assist device (LVAD) implantation. The study aims to understand how pre-surgical supplementation may influence the gut microbiome, systemic inflammation, malnutrition, and the risk of complications such as infections and mortality after LVAD surgery. This trial focuses on improving outcomes in hospitalized advanced heart failure patients through nutritional optimization before surgery. Participants will be divided based on their nutritional status assessed by AND-ASPEN criteria. Well-nourished patients are randomized to receive either one or three Ensure Surgery shakes daily from consent until LVAD implantation, while malnourished or at-risk patients receive three shakes daily. The intervention occurs in the preoperative period, aiming to optimize immune defense and nutrition before surgery. During the study, participants will have blood and stool samples collected at multiple time points before and after surgery, including baseline, day 5, pre-VAD, discharge (around day 25), and post-discharge follow-up (around day 55). Researchers will measure changes in gut microbial diversity, inflammatory markers such as C-reactive protein and various cytokines, and clinical outcomes including infections, intensive care unit length of stay, and mortality up to two years. This comprehensive monitoring will help assess the impact of nutritional supplementation on patient recovery and health after LVAD placement.
CONDITIONS
Brief Title
Enhanced Nutritional Optimization in LVAD Trial
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age greater than 18 years
- Currently hospitalized
- Scheduled for left ventricular assist device (LVAD) therapy and enrolled at time of acceptance
You will not qualify if you...
- Currently intubated
- Having congenital heart disease
- Diagnosed with infiltrative cardiomyopathy
- Unable to tolerate oral nutrition
- Surgery expected in less than 5 days
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Treatment
Duration - Approximately 0 to 5 days until LVAD implantation
Participants receive Ensure Surgery Immunonutrition shakes daily from consent until LVAD implantation to optimize nutritional status before surgery.
Daily intake during preoperative period
Post-operative Follow-up
Duration - Approximately 25 days post-surgery
Participants are monitored for outcomes including infections, length of ICU stay, and recovery after LVAD implantation.
Follow-up visits up to Day 25
Long-term Monitoring
Duration - Up to 2 years after surgery
Participants are observed for longer-term outcomes including mortality and health status up to 2 years after LVAD implantation.
Periodic follow-up visits during long-term monitoring
Trial Site Locations
Total: 1 location
1
Columbia University Medical Center
New York, New York, United States, 10032
Actively Recruiting
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Research Team
M
Melana Yuzefpolskaya, MD
A
Annamaria Ladanyi, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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Published Research Related To This Trial
Epidemiology of heart failure.
Véronique L Roger
https://pubmed.ncbi.nlm.nih.gov/23989710Comparison of neuroendocrine activation in patients with left ventricular dysfunction with and without congestive heart failure. A substudy of the Studies of Left Ventricular Dysfunction (SOLVD).
G S Francis, C Benedict, D E Johnstone...
https://pubmed.ncbi.nlm.nih.gov/2146040Circulating concentrations of proinflammatory cytokines in mild or moderate heart failure secondary to ischemic or idiopathic dilated cardiomyopathy.
M A Munger, B Johnson, I J Amber...
https://pubmed.ncbi.nlm.nih.gov/8651123Circulating levels of cytokines and their endogenous modulators in patients with mild to severe congestive heart failure due to coronary artery disease or hypertension.
M Testa, M Yeh, P Lee...
https://pubmed.ncbi.nlm.nih.gov/8837575Heart failure is associated with depletion of core intestinal microbiota.
Mark Luedde, Thorben Winkler, Femke-Anouska Heinsen...
https://pubmed.ncbi.nlm.nih.gov/28772054Gut Microbiota Signature in Heart Failure Defined From Profiling of 2 Independent Cohorts.
Martin Kummen, Cristiane C K Mayerhofer, Beate Vestad...
https://pubmed.ncbi.nlm.nih.gov/29519360Altered intestinal function in patients with chronic heart failure.
Anja Sandek, Juergen Bauditz, Alexander Swidsinski...
https://pubmed.ncbi.nlm.nih.gov/17936155Effects of enteral nutrition on gastrointestinal function in patients who are critically ill.
Michael Schörghuber, Sonja Fruhwald
https://pubmed.ncbi.nlm.nih.gov/29533200Review of nutritional screening and assessment tools and clinical outcomes in heart failure.
Hong Lin, Haifeng Zhang, Zheng Lin...
https://pubmed.ncbi.nlm.nih.gov/26920682