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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

Must not have

Congenital heart disease

Surgery expected in <5 days

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am currently receiving LVAD therapy.

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I am currently in the hospital.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I was born with a heart condition.

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My surgery is scheduled within the next 5 days.

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I am currently on a breathing machine.

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My heart muscle is thickened and not functioning properly.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 more

Secondary study objectives

Post-LVAD Infections

Post-LVAD Length of Stay in intensive care unit

Post-LVAD Mortality

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 6Eligibility criteria met