What is the mechanism of action of this treatment?

Common treatments for Left Ventricular Dysfunction (LVD) work by enhancing the heart's pumping ability and reducing its workload. Medications such as ACE inhibitors, beta-blockers, and diuretics improve heart muscle contractility, lower blood pressure, and manage fluid balance, respectively. Treatments like the Maltodextrin solution provide a readily available source of glucose, supporting cardiac function by improving the energy supply to the heart muscle. This is vital for LVD patients as it helps maintain adequate cardiac output and prevents further deterioration of heart function.

What side effects are associated with this type of intervention?

Common treatments for Left Ventricular Dysfunction, such as glucose or carbohydrate-based solutions like Maltodextrin, aim to improve energy supply to the heart muscle. Potential side effects of these treatments can include hyperglycemia, gastrointestinal discomfort, and bloating. Other standard treatments for Left Ventricular Dysfunction include ACE inhibitors, which may cause cough, hyperkalemia, and renal dysfunction; beta-blockers, which can lead to bradycardia, fatigue, and dizziness; and diuretics, which may result in electrolyte imbalances, dehydration, and hypotension. It is important to discuss these potential side effects with a healthcare provider to tailor the treatment plan to individual needs.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of Left Ventricular Dysfunction, focusing on improving cardiac function and energy supply to the heart muscle. Notable examples include beta-blockers like carvedilol and metoprolol, which reduce the heart's workload and improve its efficiency. ACE inhibitors such as enalapril and lisinopril help relax blood vessels and improve blood flow. Additionally, angiotensin II receptor blockers (ARBs) like losartan and valsartan are used to manage heart failure by reducing strain on the heart. While these treatments do not directly provide glucose to support cardiac function, they enhance overall heart performance and energy utilization.

What other types of research exist?

Promising novel alternatives to Maltodextrin solution for Left Ventricular Dysfunction patients include: 1) D-ribose, which has been shown to improve cellular energy metabolism and support cardiac function; 2) Medium-chain triglycerides (MCTs), which provide a rapid source of energy and have been studied for their potential benefits in cardiac health; 3) Ketone esters, which can serve as an alternative energy substrate for the heart and have shown potential in improving cardiac efficiency and function. These alternatives should be discussed with a healthcare provider to determine their suitability and safety for individual patients.

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Preoperative Maltodextrin for Heart Failure

Phase 4

Waitlist Available

Led By Matthew Cameron, MDCM, MPH

Research Sponsored by Jewish General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 years of age or older

Presenting for coronary artery bypass grafting surgery

Must not have

Dysphagia

Celiac disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up first 1-48 hours after surgery

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

Summary

This trial tests if giving a carbohydrate drink (Maltodextrin) before heart surgery can help patients with weak hearts. The goal is to see if this drink improves heart function and recovery by giving the heart extra energy.

Who is the study for?

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.

What is being tested?

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).

What are the potential side effects?

Potential side effects from the Maltodextrin solution could include digestive issues due to its sugar content but specific side effects related to heart function will be closely monitored given the condition of participants.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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

Exclusion Criteria

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

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I have difficulty swallowing.

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I have celiac disease.

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I have been diagnosed with gastroparesis.

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I have Type 1 diabetes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 48 hours after surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 48 hours after surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 48 hours after surgery for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Intraoperative three-dimensional left ventricular ejection fraction (3-D LVEF)

Secondary study objectives

Cardiac Index

E/e' ratio

Hospital Length of Stay

+11 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Intervention GroupExperimental Treatment1 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 GroupPlacebo Group1 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.

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Left Ventricular Dysfunction (LVD) work by enhancing the heart's pumping ability and reducing its workload. Medications such as ACE inhibitors, beta-blockers, and diuretics improve heart muscle contractility, lower blood pressure, and manage fluid balance, respectively. Treatments like the Maltodextrin solution provide a readily available source of glucose, supporting cardiac function by improving the energy supply to the heart muscle. This is vital for LVD patients as it helps maintain adequate cardiac output and prevents further deterioration of heart function.

Manipulation of the gut microbiota by the use of prebiotic fibre does not override a genetic predisposition to heart failure.