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NCT05655910 · ClinicalTrials.gov registry record · NA
Enhanced Nutritional Optimization in LVAD Trial
A NA study of Heart Failure and Gut Microbiome, sponsored by Columbia University.
- Recruiting
- Registry status
- NA
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT05655910: Recruiting NA study of Heart Failure and Gut Microbiome, sponsored by Columbia University.
NCT05655910 is a NA study of Heart Failure and Gut Microbiome that is actively recruiting participants, run by Columbia University. The registered enrollment target is 50 participants, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05655910, a NA study of Heart Failure and Gut Microbiome, is actively recruiting participants, sponsored by Columbia University.
- RECRUITING
- Registry status
- NA
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this clinical trial is to assess whether a peri-operative intervention with nutritional immune modulating intervention (Ensure Surgery Immunonutrition shake) has beneficial effects on the complex interplay between gut microbiome, systemic inflammation and malnutrition that is commonly present in advanced heart failure and the adverse events associated with left ventricular assist device (LVAD) placement in hospitalized advanced heart failure patients awaiting LVAD implantation. The main questions it aims to answer are: * Will pre-surgical supplementation with Ensure Surgery affect gut microbial composition and levels of inflammation among heart failure patients undergoing LVAD implantation? * Will pre-surgical supplementation with Ensure Surgery affect post-surgical morbidity (e.g., infections, intensive care unit length of stay (LOS)) and mortality? Participants will be evaluated for malnutrition and will be given Ensure Surgery Immunonutrition shake to drink in the days preceding their LVAD surgery. Blood and stool samples will be collected at prespecified timepoints before and after surgery. Researchers will compare malnourished participants drinking Ensure Surgery 3/day with well-nourished participants randomized to drink either 1/day or 3/day to see if any of the above supplementation strategies change the gut microbial composition, levels of inflammation, and post-surgical morbidity and mortality.
Primary Outcome
Change in alpha diversity (a measure of microbiome diversity applicable to a single sample) in collected stool samples.
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Ensure Surgery Immunonutrition shake
Study Locations (1)
New York
- Columbia University Medical Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2022-09-22 |
| Est. Completion | 2027-01 |
| Phase | NA |
What NCT05655910 shows while recruiting
NCT05655910 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (98% lower).
The record links to 3 conditions, with Heart Failure appearing as the primary indexed condition, and to 1 intervention - of which Ensure Surgery Immunonutrition shake is the first listed.
NCT05655910 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT05655910 about?
NCT05655910 is a clinical study titled "Enhanced Nutritional Optimization in LVAD Trial". The goal of this clinical trial is to assess whether a peri-operative intervention with nutritional immune modulating intervention (Ensure Surgery Immunonutrition shake) has beneficial effects on the complex interplay between gut microbiome, systemic inflammation and malnutrition that is commonly pr...
What is the current status of trial NCT05655910?
This trial is currently recruiting. It is a NA study. The enrollment target is 50 participants. The study started on 2022-09-22. Estimated completion is 2027-01.
What conditions does trial NCT05655910 study?
This clinical trial studies the following conditions: Heart Failure, Gut Microbiome, Nutritional Deficiency.
What interventions are being tested in trial NCT05655910?
The interventions under investigation include: Ensure Surgery Immunonutrition shake (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT05655910?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05655910 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05655910's enrollment target sits among peer trials
50 281st of 397 higher than 106 of 397 other Heart Failure trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Heart Failure trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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