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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

ASTRID-HF Trial Summary

This trial will assess if higher intake of protein can help prevent muscle wasting in people with heart failure.

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.Check my eligibility

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.See study design

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.

ASTRID-HF Trial Eligibility Criteria

Inclusion Criteria

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

Select...

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

ASTRID-HF Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

6-minute walk test (6MWT)

Appendicular Lean Mass (ALM)

Handgrip strength

+2 more

Other outcome measures

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

Fat free mass (FFM)

Fat mass (FM)

+5 more

ASTRID-HF 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: Sham comparator armActive Control1 Intervention

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

Group III: No intervention armActive Control1 Intervention

0 g/day protein supplementation (no Ensure bottles)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ensure Max Protein

2019

N/A

~30

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH

3,837 Previous Clinical Trials

47,851,474 Total Patients Enrolled

206 Trials studying Heart Failure

677,328 Patients Enrolled for Heart Failure

Tufts Medical CenterLead Sponsor

255 Previous Clinical Trials

255,167 Total Patients Enrolled

10 Trials studying Heart Failure

2,616 Patients Enrolled for Heart Failure

Media Library

Ensure Max Protein (Protein Supplementation) Clinical Trial Eligibility Overview. Trial Name: NCT05627440 — N/A

Heart Failure Research Study Groups: Experimental arm, Sham comparator arm, No intervention arm

Heart Failure Clinical Trial 2023: Ensure Max Protein Highlights & Side Effects. Trial Name: NCT05627440 — N/A

Ensure Max Protein (Protein Supplementation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05627440 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there still capacity for participants in this experiment?

"According to the clinicaltrials.gov website, this particular medical trial is not actively accepting patients at present. The study was initially posted on January 16th 2023 and last modified on November 17th 2022. Despite this inactivity, there are 786 other experiments that require volunteers presently."

Answered by AI

Is the current clinical trial limited to participants below 25 years of age?

"This study requires that prospective participants are between the ages of 18 and 100. There are 63 trials for those below the age of majority, and 733 studies specifically designed for seniors."

Answered by AI

Who would fit the criteria to partake in this research endeavor?

"This clinical trial is recruiting a cohort of 120 patients aged between 18 and 100 with muscle tissue. To be accepted into the study, participants must have an LVEF ≤40%, NYHA class II to IV symptoms or NT-proBNP >300 pg/mL, as well as one (or more) of the following markers in their medical history: i) Inotropic therapy; ii) 1+ HF hospitalizations; iii) LVEF ≤25%; iv) Peak VO2 <50% predicted or ≤16 mL/kg/min; v) 6-minute walk distance <300 meters; vi) Unintentional"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A SkeleTal Muscle Recovery Intervention With Dietary Protein in Heart Failure

2023. "A SkeleTal Muscle Recovery Intervention With Dietary Protein in Heart Failure". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05627440.