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Nutritional Optimization for Heart Failure (ENOL Trial)
N/A
Recruiting
Led By Melana Yuzefpolskaya, MD
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Undergoing LVAD therapy (enrolled at time of acceptance)
Hospitalized
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
ENOL Trial Summary
This trial will assess if pre-surgery nutrition with Ensure Surgery could reduce infections & mortality in hospitalized advanced heart failure patients awaiting LVAD surgery.
Who is the study for?
This trial is for adults over 18 with advanced heart failure who are hospitalized and awaiting LVAD implantation. They must be able to eat by mouth and not have congenital heart disease, infiltrative cardiomyopathy, or require intubation. Surgery should not be expected within the next 5 days.Check my eligibility
What is being tested?
Researchers are testing if drinking Ensure Surgery Immunonutrition shake before surgery can improve gut health, reduce inflammation, and decrease complications after getting an LVAD. Malnourished patients will drink it three times a day while well-nourished ones will be randomly chosen to drink once or thrice daily.See study design
What are the potential side effects?
Potential side effects from Ensure Surgery shakes may include digestive discomfort such as nausea or diarrhea due to its nutritional content aimed at boosting immune function prior to surgery.
ENOL Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am currently receiving LVAD therapy.
Select...
I am currently in the hospital.
ENOL Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Alpha Diversity (Baseline and Day 5)
Change in Alpha Diversity (Baseline and Discharge)
Change in Alpha Diversity (Baseline and Post-Discharge Follow-up)
+33 moreSecondary outcome measures
Post-LVAD Infections
Post-LVAD Length of Stay in intensive care unit
Post-LVAD Mortality
ENOL Trial Design
3Treatment groups
Experimental Treatment
Group I: Group 2 (at risk/malnourished)Experimental Treatment1 Intervention
Patients assessed as at risk for malnourishment or malnourished based on AND-ASPEN criteria automatically assigned to receive 3 Ensure Surgery Immunonutrition shake per day during the days from consent to LVAD implantation.
Group II: Group 1 (Not malnourished) - 3 products per dayExperimental Treatment1 Intervention
Patients assessed as well-nourished based on AND-ASPEN criteria and randomized to receive 3 Ensure Surgery Immunonutrition shake per day during the days from consent to LVAD implantation.
Group III: Group 1 (Not malnourished) - 1 product per dayExperimental Treatment1 Intervention
Patients assessed as well-nourished based on AND-ASPEN criteria and randomized to receive 1 Ensure Surgery Immunonutrition shake per day during the days from consent to LVAD implantation.
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Who is running the clinical trial?
Abbott NutritionIndustry Sponsor
168 Previous Clinical Trials
33,454 Total Patients Enrolled
Columbia UniversityLead Sponsor
1,432 Previous Clinical Trials
2,460,923 Total Patients Enrolled
20 Trials studying Heart Failure
6,219 Patients Enrolled for Heart Failure
Melana Yuzefpolskaya, MDPrincipal InvestigatorColumbia University
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I was born with a heart condition.I am currently receiving LVAD therapy.My surgery is scheduled within the next 5 days.I am currently on a breathing machine.I am currently in the hospital.I am older than 18 years.My heart muscle is thickened and not functioning properly.You cannot eat food by mouth.
Research Study Groups:
This trial has the following groups:- Group 1: Group 1 (Not malnourished) - 3 products per day
- Group 2: Group 2 (at risk/malnourished)
- Group 3: Group 1 (Not malnourished) - 1 product per day
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research project actively recruiting participants?
"Accurate. According to information available on clinicaltrials.gov, this medical study is actively recruiting participants since its initial posting on September 22nd 2022 and the latest revision was made in December 9th 2022. The research team needs 50 patients from a single site to complete their trial."
Answered by AI
How many individuals are enrolled in the current research endeavor?
"That is correct. The public records on clinicaltrials.gov point to this study still looking for patients, which was initially posted in September of 2022 and last updated less than two months ago. This investigation requires 50 people from one single medical centre."
Answered by AI
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