Your session is about to expire
← Back to Search
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 belowSelect...
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
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 moreOther outcome measures
Activin A and Follistatin-related gene (FSTL)-3
Fat free mass (FFM)
Fat mass (FM)
+5 moreASTRID-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: 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
Find a Location
Who is running the clinical trial?
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,847 Previous Clinical Trials
47,818,116 Total Patients Enrolled
206 Trials studying Heart Failure
677,358 Patients Enrolled for Heart Failure
Tufts Medical CenterLead Sponsor
256 Previous Clinical Trials
255,617 Total Patients Enrolled
10 Trials studying Heart Failure
2,616 Patients Enrolled for Heart Failure
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are allergic to milk or have trouble digesting milk sugar.I weigh at least 350 pounds or my BMI is 40 or more.I am on standard treatment for my condition, unless I can't tolerate it.I have had severe heart failure signs in the last year, like hospital stays or major weight loss.I am between 18 and 100 years old.I have a condition that causes muscle weakness or wasting.My heart's pumping ability is reduced, and I have moderate to severe heart symptoms or high NT-proBNP levels.I have a history of severe heart issues or very poor kidney function.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental arm
- Group 2: No intervention arm
- Group 3: Sham comparator arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Share this study with friends
Copy Link
Messenger