Nutritional Optimization for Heart Failure

(ENOL Trial)

Overseen By Melana Yuzefpolskaya, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Disqualifiers: Intubated, congenital heart disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

50 Participants Needed

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.

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

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.

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

Abbott Nutrition

Industry Sponsor

Trials

173

Recruited

33,700+

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

Findings from Research

In a study of 45 postoperative patients with esophageal carcinoma, the enteral nutrition formulas Ensure and Nutrison led to faster recovery of gastrointestinal function compared to Peptison, with recovery times of approximately 52.4 and 50.8 hours respectively, versus 60.3 hours for Peptison.

All three nutrition formulas showed similar safety profiles and effectiveness in improving nutritional indices, but Ensure was significantly more cost-effective, costing about 443.3 RMB compared to 639.5 RMB for Nutrison and 990.5 RMB for Peptison.

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]

Laparoscopic procedures enable earlier oral intake after colorectal surgery, which is a key component of enhanced recovery after surgery (ERAS) programs.

Implementing ERAS protocols, such as consuming a carbohydrate-rich beverage before surgery and allowing oral liquid intake on the day of surgery, can lead to reduced postoperative complications and shorter hospital stays.

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]

In a study of 60 patients undergoing open colorectal surgery, preoperative carbohydrate (CHO) drinks significantly reduced postoperative neutrophil-to-lymphocyte ratio (NLR) values, indicating a lower inflammatory response compared to those who fasted before surgery.

The CHO group experienced no major postoperative complications, while the fasting group had a higher incidence of severe complications, suggesting that preoperative carbohydrate loading may enhance recovery and reduce surgical stress.

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]

In a study of 3,375 adults undergoing elective colorectal surgery, preoperative immunonutrition was associated with a lower rate of prolonged hospital stays (13.8% vs 17.3%) compared to those who did not receive it, suggesting it may help reduce complications.

While the overall rate of serious adverse events was not significantly different between the two groups (6.8% vs 8.3%), the findings support the use of immunonutrition as a beneficial intervention in community settings, aligning with previous randomized controlled trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

A study involving 20 healthy volunteers found that a clear carbohydrate drink (CCD) empties from the stomach significantly faster than two types of oral nutritional supplements (ONS), indicating that gastric emptying is influenced more by nutrient load than by volume or viscosity.

The results suggest that it is safe to administer the CCD just 2 hours before surgery, while the ONS drinks should be given at least 3 hours prior to ensure proper gastric emptying.

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]

In a study of 37 cardiac surgery patients with hemodynamic failure, early enteral nutrition (EN) was found to be feasible and safe, with no serious complications like mesenteric ischemia reported.

Despite the safety of early EN, achieving the targeted energy intake was challenging, as only 40.4% of patients met their energy goals, highlighting the need for careful monitoring of nutritional delivery.

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]

In a study of 570 heart failure inpatients, the use of oral nutrition supplements (ONS) was linked to a higher length of stay (LOS) in the hospital, with an odds ratio of 2.43, suggesting that ONS alone may not effectively reduce LOS.

Factors such as comorbidity, discharge destination, and dietitian consultations also influenced LOS, indicating that a comprehensive approach is needed to improve care and reduce hospital stays for heart failure patients.

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]

Preoperative feeding with a carbohydrate-based drink containing glutamine and antioxidants significantly increased liver glycogen reserves by 44% and elevated plasma glutamine and antioxidant levels, with no drink-related complications reported.

The study suggests that the reduction in muscle PDK4 expression in patients receiving the oral nutritional supplement may help explain how this intervention mitigates postoperative insulin resistance, highlighting its potential efficacy in improving metabolic outcomes after surgery.

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]

In a study of 215 colon cancer patients, early enteral nutrition (started within 12 hours after surgery) was found to be safe and effective for accelerating recovery compared to starting nutrition after the alimentary canal functions were restored.

The use of a balanced liquid mixture, 'Frezubin,' in early enteral nutrition supports the idea that timely nutritional support can enhance postoperative rehabilitation in colon cancer patients.

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]