Preoperative Maltodextrin for Heart Failure

Overseen By Mirana Rakotoarivony

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Jewish General Hospital

Disqualifiers: Dysphagia, Gastroparesis, Celiac, Type 1 diabetes

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a maltodextrin solution (a type of carbohydrate drink) can improve heart function in individuals undergoing coronary artery bypass surgery, particularly those with reduced left ventricular ejection fraction (a condition where the heart doesn't pump blood effectively). Participants will receive either the maltodextrin drink or a placebo (a harmless substance with no active treatment) before surgery. This study may suit individuals scheduled for early morning heart bypass surgery who have been informed that their heart's pumping ability is less than optimal. As a Phase 4 trial, this research aims to understand how the already FDA-approved treatment benefits a broader range of patients.

Do I need to stop my current medications for the 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 is the safety track record for the Maltodextrin solution?

Research has shown that maltodextrin is generally safe for people. Studies found that patients who drank a maltodextrin solution before surgery felt less hungry, thirsty, and tired, indicating the solution is usually well-tolerated. Another study demonstrated that taking maltodextrin before heart surgery improved recovery, with patients needing fewer medications and spending less time in the hospital. Although these studies did not identify any serious side effects, discussing your specific situation with your doctor before joining a trial is always important. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike standard heart failure treatments like beta-blockers and ACE inhibitors, which primarily manage symptoms and improve heart function over time, the maltodextrin solution is being explored for its potential as a preoperative booster for heart surgery patients. This solution is unique because it provides a quick energy source, potentially improving the body's resilience to the stress of surgery. Researchers are excited about this approach because it might enhance recovery and outcomes in heart failure patients undergoing surgery, offering a novel pre-surgery nutritional strategy that could work alongside existing treatments.

What evidence suggests that Maltodextrin solution might be an effective treatment for heart failure?

Research has shown that Maltodextrin, a type of carbohydrate, might help improve heart function during surgery. Previous studies found that taking Maltodextrin before surgery can reduce hunger, thirst, and tiredness in patients. This suggests it might make patients more comfortable and possibly aid in their recovery. In this trial, participants in the intervention group will receive Maltodextrin to evaluate its effects. While direct evidence that Maltodextrin improves heart function during heart surgery is not yet available, its ability to ease pre-surgery discomfort is promising. Researchers are actively studying its potential benefits for heart surgery patients to gain clearer insights. ^{2 3 4 6 7}

Who Is on the Research Team?

Matthew Cameron, MDCM, MPH

Principal Investigator

McGill University

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are scheduled for coronary artery bypass grafting surgery and have a left ventricular ejection fraction below 50%. It's specifically for surgeries starting at 7:30 am. People with swallowing difficulties, slow stomach emptying, intolerance to oral intake, celiac disease, or type 1 diabetes cannot participate.

Inclusion Criteria

I am scheduled for surgery to improve blood flow to my heart.

Your heart's pumping ability is less than 50% before surgery.

First case of the day (7:30am start time)

Exclusion Criteria

You cannot swallow or tolerate taking medicine by mouth.

I have difficulty swallowing.

I have celiac disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Preparation

Participants receive an oral preparation of Maltodextrin or placebo the night before and within 2-3 hours before surgery

1 day

1 visit (in-person)

Surgery and Intraoperative Assessment

Intraoperative assessment of left ventricular ejection fraction and myocardial glycogen content

1 day

1 visit (in-person)

Postoperative Recovery

Quality of Recovery assessed 48 hours after surgery, monitoring of insulin requirements, and other postoperative measures

1-7 days

Daily monitoring (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including postoperative complications and hospital length of stay

1-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Maltodextrin solution
• Placebo solution
• Water solution

Trial Overview The study is testing if drinking a Maltodextrin solution before heart surgery can help maintain cardiac function better than a placebo. Patients are randomly assigned to one of the two groups without knowing which one they're in (double-blinded).

How Is the Trial Designed?

Group I: Intervention Group Experimental Treatment 1 Intervention

Patients in the intervention group will receive an oral preparation of 50 grams of Maltodextrin solution mixed in 400 millilitres (mL) of water twice the night before surgery and within 2-3 hours before surgery. The entire drink is meant to be consumed within 15 minutes.

Group II: Placebo Group Placebo Group 1 Intervention

Patients in the intervention group will receive a placebo in 400 millilitres (mL) of water twice the night before surgery and within 2-3 hours before surgery. The entire drink is meant to be consumed within 15 minutes.

Who Is Running the Clinical Trial?

Jewish General Hospital

Lead Sponsor

Trials

144

Recruited

283,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05188222

Preoperative Maltodextrin's Effect on Cardiac Function in ... A randomized, controlled, double-blinded clinical trial evaluating the effect of the administration of a Maltodextrin solution on cardiac function in patients ...

2. withpower.com withpower.com/trial/preoperative-maltodextrin-for-heart-failure-b723a

Preoperative Maltodextrin for Heart Failure Trial Overview The study is testing if drinking a Maltodextrin solution before heart surgery can help maintain cardiac function better than a placebo.

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05188222/preoperative-maltodextrins-effect-on-cardiac-function-in-cardiac-surgery

Preoperative Maltodextrin's Effect on Cardiac Function in ... A randomized, controlled, double-blinded clinical trial evaluating the effect of the administration of a Maltodextrin solution on cardiac ...

4. journals.lww.com journals.lww.com/md-journal/fulltext/2025/06270/preoperative_maltodextrin_solution_intake_improves.74.aspx

Preoperative maltodextrin solution intake improves patient... Preoperative maltodextrin intake significantly reduces perioperative hunger, thirst, and fatigue in patients undergoing gynecological laparoscopic surgery.

5. sciencedirect.com sciencedirect.com/science/article/pii/S0899900713000956

Shrinking preoperative fast time with maltodextrin and ... Blood samples were collected the morning before surgery and on postoperative day 2. Results. Overall mortality was 4.5% (one case, control group). The duration ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05188222

Preoperative Maltodextrin's Effect on Cardiac Function in ... This randomized, double-blinded clinical trial will test the primary hypothesis that patients receiving preoperative maltodextrin will have an improved ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7600335/

The Effect of Preoperative Carbohydrate Loading on ... Preoperative OCH in patients undergoing cardiac surgery demonstrated a 20% reduction in the use of inotropic drugs, a 50% reduction of the length of ICU stay.