Nutritional Optimization for Heart Failure
(ENOL Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if the Ensure Surgery Immunonutrition shake can benefit individuals with severe heart failure who are about to receive a heart pump device, known as an LVAD. Researchers seek to discover whether consuming this shake before surgery can enhance gut health, reduce inflammation, and decrease complications such as infections or prolonged hospital stays. Participants will be grouped based on nutritional needs, with some consuming the shake once daily and others three times daily, to identify the most effective regimen. The trial is suitable for hospitalized patients preparing for LVAD surgery who are either well-nourished or at risk of malnutrition. As an unphased trial, it offers a unique opportunity to contribute to understanding how nutrition can affect surgical outcomes.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that this nutritional intervention is safe for heart failure patients?
Research shows that the Ensure Surgery Immunonutrition shake supports the immune system and aids recovery after surgery. This drink contains protein, arginine (an amino acid), and omega-3s, which help the body heal. Studies have found that these ingredients are usually well-tolerated and beneficial for post-surgery recovery.
A doctor should supervise the use of the shake, monitoring progress to quickly address any side effects. No reports of serious side effects have emerged, making it a safe choice for many preparing for surgery.12345Why are researchers excited about this trial?
Researchers are excited about the Ensure Surgery Immunonutrition shake because it offers a nutritional approach to support heart failure patients, particularly those undergoing LVAD implantation. Unlike standard heart failure treatments like medications or surgical interventions that primarily target heart function, this shake focuses on optimizing nutritional status. It's packed with essential nutrients and designed to boost immune function and recovery. This is especially important for malnourished patients, who receive a higher dosage, as good nutrition can significantly impact surgical outcomes and overall health.
What evidence suggests that Ensure Surgery Immunonutrition shake might be an effective treatment for heart failure?
Research has shown that the Ensure Surgery Immunonutrition shake can support the immune system and aid recovery after surgery. This shake contains 18 grams of high-quality protein, which helps repair tissues and heal wounds. It also includes omega-3 fatty acids, such as EPA and DHA, which can reduce swelling. Studies have found that reducing swelling and improving nutrition can lead to better surgical outcomes, including fewer infections and shorter hospital stays. In this trial, well-nourished participants will receive either 1 or 3 shakes per day, while those at risk for malnourishment or who are malnourished will receive 3 shakes per day. Although specific data for heart failure patients with LVADs is limited, the shake's ingredients are known to support overall recovery and health.12467
Who Is on the Research Team?
Melana Yuzefpolskaya, MD
Principal Investigator
Columbia University
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-operative Nutritional Intervention
Participants receive Ensure Surgery Immunonutrition shake to optimize nutritional status before LVAD implantation
Surgery and Immediate Post-operative
Participants undergo LVAD implantation and are monitored for immediate post-operative outcomes
Follow-up
Participants are monitored for safety and effectiveness after discharge, including changes in biomarkers and microbiome
What Are the Treatments Tested in This Trial?
Interventions
- Ensure Surgery Immunonutrition shake
Find a Clinic Near You
Who Is Running the Clinical Trial?
Columbia University
Lead Sponsor
Abbott Nutrition
Industry Sponsor
Robert B. Ford
Abbott Nutrition
Chief Executive Officer since 2020
Bachelor's degree from Boston College, MBA from UC Berkeley, Haas School of Business
Melissa Brotz
Abbott Nutrition
Chief Marketing Officer
Bachelor's degree in Journalism from Northwestern University