What is the mechanism of action of this treatment?

Heart failure with reduced ejection fraction (HFrEF) often involves severe skeletal muscle wasting and catabolic weight loss. Dietary protein supplementation, as studied in the trial, aims to counteract these effects by targeting catabolic metabolism pathways such as GDF-15 and ActRII. This approach is crucial for HFrEF patients as it can help reverse muscle wasting, improve muscle mass and function, and enhance overall quality of life. By addressing these metabolic disturbances, dietary protein supplementation may reduce hospitalizations and improve survival rates in heart failure patients.

What side effects are associated with this type of intervention?

Common treatments for heart failure, such as dietary protein supplementation, aim to counteract muscle wasting by targeting catabolic metabolism pathways like GDF-15 and ActRII. While specific side effects of protein supplementation in heart failure patients are not detailed, general side effects of high protein intake can include kidney strain, dehydration, and digestive issues such as bloating and constipation. Other heart failure treatments, such as medications, may cause side effects like dizziness, fatigue, hypotension, and electrolyte imbalances. It is essential to monitor these side effects closely and consult with a healthcare provider to manage them effectively.

What prior FDA approvals exist?

FDA-approved treatments for heart failure primarily include medications that manage symptoms and improve heart function, such as ACE inhibitors, beta-blockers, diuretics, and aldosterone antagonists. While these treatments do not specifically target catabolic metabolism pathways like GDF-15 and ActRII, they help reduce the overall burden on the heart and improve patient outcomes. There are no specific FDA-approved treatments that focus on dietary protein supplementation or directly counteract muscle wasting through these pathways. However, ongoing research, such as the trial on dietary protein supplementation, aims to explore new avenues for managing muscle wasting in heart failure patients.

What other types of research exist?

Promising novel alternatives to dietary protein supplementation for heart failure patients include myostatin inhibitors, cell therapy using cardiosphere-derived cells (CDCs), and gene therapy approaches like rAAVrh74.MHCK7.microdystrophin gene transfer.

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Protein Supplementation

High-Protein Nutrition for Heart Failure-related Muscle Wasting (ASTRID-HF Trial)

N/A

Recruiting

Research Sponsored by Tufts Medical Center

Eligibility Criteria Checklist

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

Must have

Left ventricular ejection fraction (LVEF) ≤40%, New York Heart Association (NHYA) class II to IV symptoms or N-terminal pro B-natriuretic peptide (NT-proBNP) >300 pg/mL

Be older than 18 years old

Must not have

History of left ventricular assist device (LVAD), heart transplantation, or estimated glomerular filtration rate (eGFR) <20 mL/min/1.73 m2

Weight ≥350 pounds and/or BMI ≥40 kg/m2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether protein supplements can help patients with heart failure who are losing muscle. The study will compare different amounts of protein to see if it helps build muscle in these patients. Researchers believe that extra protein might counteract the body's muscle-wasting processes.

Who is the study for?

This trial is for adults aged 18-100 with heart failure and reduced ejection fraction (HFrEF), experiencing muscle wasting. They must be on standard heart failure treatments, have a left ventricular ejection fraction ≤40%, and show signs of severe heart failure like hospitalizations or significant weight loss. Excluded are pregnant women, those with certain muscle disorders, severe kidney issues, allergies to milk/protein/lactose intolerance/galactosemia, or very high body weight/BMI.

What is being tested?

The study tests if different doses of dietary protein from Ensure(R) products can prevent muscle wasting in patients with HFrEF. Participants will be divided into three groups: one without protein supplementation, one with a low dose, and another with a high dose. The goal is to see if increased dietary protein affects muscle mass in the limbs.

What are the potential side effects?

While not explicitly listed in the provided information, potential side effects may include gastrointestinal discomfort due to increased protein intake such as bloating or constipation especially among patients who might have pre-existing digestive issues.

Eligibility Criteria

Inclusion Criteria

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

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My heart's pumping ability is reduced, and I have moderate to severe heart symptoms or high NT-proBNP levels.

Exclusion Criteria

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

Select...

I have a history of severe heart issues or very poor kidney function.

Select...

I weigh at least 350 pounds or my BMI is 40 or more.

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I have a condition that causes muscle weakness or wasting.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

6-minute walk test (6MWT)

Appendicular Lean Mass (ALM)

Handgrip strength

+2 more

Other study objectives

Activin A and Follistatin-related gene (FSTL)-3

Fat free mass (FFM)

Fat mass (FM)

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Experimental armExperimental Treatment1 Intervention

30 g/day protein supplementation (1 Ensure Max Protein® bottle)

Group II: No intervention armActive Control1 Intervention

0 g/day protein supplementation (no Ensure bottles)

Group III: Sham comparator armActive Control1 Intervention

9 g/day protein supplementation (1 Ensure Original® bottle)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ensure Max Protein

2019

N/A

~30

0 / 4Eligibility 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

Heart failure with reduced ejection fraction (HFrEF) often involves severe skeletal muscle wasting and catabolic weight loss. Dietary protein supplementation, as studied in the trial, aims to counteract these effects by targeting catabolic metabolism pathways such as GDF-15 and ActRII. This approach is crucial for HFrEF patients as it can help reverse muscle wasting, improve muscle mass and function, and enhance overall quality of life. By addressing these metabolic disturbances, dietary protein supplementation may reduce hospitalizations and improve survival rates in heart failure patients.

Targeting metabolic disturbance in the diabetic heart.