Nutritional Optimization for Heart Failure

(ENOL Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Melana Yuzefpolskaya, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Columbia University

Disqualifiers: Intubated, congenital heart disease, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this 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 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.

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 data supports the effectiveness of the treatment Ensure Surgery Immunonutrition shake and related drinks for heart failure?

Research shows that nutritional drinks, like those used in surgeries, can help reduce complications and improve recovery by providing essential nutrients and reducing stress on the body. While not specific to heart failure, these benefits might also support heart health. ^{1 2 3 4 5}

Is the nutritional treatment generally safe for humans?

The studies suggest that nutritional supplements, including those similar to Ensure products, are generally safe for use in humans, as they have been used in various medical conditions like surgery recovery and heart failure without major safety concerns. ^{1 3 4 6 7}

How does the Nutritional Optimization for Heart Failure treatment differ from other treatments for heart failure?

The Nutritional Optimization for Heart Failure treatment is unique because it focuses on optimizing nutrition, potentially using specialized nutritional supplements, to support heart health, unlike traditional heart failure treatments that primarily involve medications or surgical interventions. This approach may include components like arginine-enriched supplements, which have shown benefits in surgical recovery, suggesting a novel way to manage heart failure by enhancing the body's nutritional status. ^{1 4 5 8 9}

Research Team

Melana Yuzefpolskaya, MD

Principal Investigator

Columbia University

Eligibility Criteria

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

I am currently receiving LVAD therapy.

I am currently in the hospital.

I am older than 18 years.

Exclusion Criteria

I was born with a heart condition.

My surgery is scheduled within the next 5 days.

I am currently on a breathing machine.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative Nutritional Intervention

Participants receive Ensure Surgery Immunonutrition shake to optimize nutritional status before LVAD implantation

Approximately 5 days

Daily monitoring

Surgery and Immediate Post-operative

Participants undergo LVAD implantation and are monitored for immediate post-operative outcomes

Approximately 25 days

In-hospital stay

Follow-up

Participants are monitored for safety and effectiveness after discharge, including changes in biomarkers and microbiome

Approximately 30 days post-discharge

Regular follow-up visits

Treatment Details

Interventions

• Ensure Surgery Immunonutrition shake (Dietary Supplement)

Trial Overview 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.

Participant Groups

Group I: Group 2 (at risk/malnourished) Experimental Treatment 1 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 day Experimental Treatment 1 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 day Experimental Treatment 1 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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Columbia University Medical Center New York, NY

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1529

Patients Recruited

2,832,000+

Abbott Nutrition

Industry Sponsor

Trials

173

Patients Recruited

33,700+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Study of different enteral nutrition formulation treatment after esophagectomy]. Liu, SY., Chen, XF., Wang, F., et al.[2012]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Current practices of perioperative nutritional therapy in colorectal surgery]. Ohge, H., Okajima, M., Hinoi, T., et al.[2011]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Preoperative Oral Carbohydrate Loading on Neutrophil/Lymphocyte Ratio and Postoperative Complications following Colorectal Cancer Surgery: A Randomized Controlled Study. Rizvanović, N., Nesek Adam, V., Kalajdžija, M., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preoperative Immunonutrition and Elective Colorectal Resection Outcomes. Thornblade, LW., Varghese, TK., Shi, X., et al.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gastric emptying of three liquid oral preoperative metabolic preconditioning regimens measured by magnetic resonance imaging in healthy adult volunteers: a randomised double-blind, crossover study. Lobo, DN., Hendry, PO., Rodrigues, G., et al.[2009]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early enteral nutrition in patients with hemodynamic failure following cardiac surgery. Flordelís Lasierra, JL., Pérez-Vela, JL., Umezawa Makikado, LD., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral nutritional supplement use in relation to length of stay in heart failure patients at a regional medical center. Babb, EB., Rohrer, J.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cellular mechanisms underlying the protective effects of preoperative feeding: a randomized study investigating muscle and liver glycogen content, mitochondrial function, gene and protein expression. Awad, S., Constantin-Teodosiu, D., Constantin, D., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[INFLUENCE TIMING OF THE START OF ENTERAL NUTRITION ON THE IMMEDIATE RESULTS OF SURGICAL TREATMENT OF COLON CANCER]. Mahmudov, DE.[2016]

References

1. China pubmed.ncbi.nlm.nih.gov

[Study of different enteral nutrition formulation treatment after esophagectomy]. [2012]

2. Japan pubmed.ncbi.nlm.nih.gov

[Current practices of perioperative nutritional therapy in colorectal surgery]. [2011]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of Preoperative Oral Carbohydrate Loading on Neutrophil/Lymphocyte Ratio and Postoperative Complications following Colorectal Cancer Surgery: A Randomized Controlled Study. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Preoperative Immunonutrition and Elective Colorectal Resection Outcomes. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Gastric emptying of three liquid oral preoperative metabolic preconditioning regimens measured by magnetic resonance imaging in healthy adult volunteers: a randomised double-blind, crossover study. [2009]

6. United States pubmed.ncbi.nlm.nih.gov

Early enteral nutrition in patients with hemodynamic failure following cardiac surgery. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Oral nutritional supplement use in relation to length of stay in heart failure patients at a regional medical center. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Cellular mechanisms underlying the protective effects of preoperative feeding: a randomized study investigating muscle and liver glycogen content, mitochondrial function, gene and protein expression. [2021]

9. Ukraine pubmed.ncbi.nlm.nih.gov

[INFLUENCE TIMING OF THE START OF ENTERAL NUTRITION ON THE IMMEDIATE RESULTS OF SURGICAL TREATMENT OF COLON CANCER]. [2016]