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NCT Number: NCT05627440

A SkeleTal Muscle Recovery Intervention With Dietary Protein in Heart Failure

Severe skeletal wasting and catabolic weight loss are highly common among patients with heart failure with reduced ejection fraction (HFrEF). This prospective randomized controlled trial will compare changes in the muscle mass in the arms and the legs (appendicular lean mass) in patients with HFrEF randomized between 3 groups of no, low- or high-dose protein supplementation. The dietary protein supplementation will be Ensure(R) products manufactured by Abbott Nutrition. The Investigators hypothesize that skeletal muscle wasting in HFrEF is promoted by neurohumoral activation of catabolic metabolism (such as GDF-15 and ActRII pathways) and can be at least partially reversed by increased dietary protein intake. It is anticipated that this study will determine whether dietary protein supplementation helps to prevent muscle wasting and will advance understanding of the GDF-15 and ActRII muscle wasting pathways.

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Key information

Conditions

Heart Failure Atrophy Cardiovascular Diseases Heart Diseases Muscle Atrophy Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tufts Medical Center, Boston, Massachusetts, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Age 18 years to 100 years, inclusive
  • Receiving guideline-directed medical therapy (GDMT), unless contraindicated or not tolerated
  • Any of the following markers of severe HF within prior 12 months: i) Inotropic therapy; ii) 1 or more HF hospitalizations; iii) LVEF ≤25%; iv) Peak oxygen consumption (VO2) <50% predicted or ≤16 mL/kg/min; v) 6-minute walk distance <300 meters; vi) Unintentional weight loss >5% of bodyweight over the past year; vii) Moderate or severe muscle wasting on physical examination; viii) NT-proBNP ≥900 pg/mL

Exclusion criteria

  • Pregnancy, planning to become pregnant, or women of reproductive potential unwilling to complete pre-DXA urine pregnancy test before first DXA or randomization
  • History of left ventricular assist device (LVAD), heart transplantation, or estimated glomerular filtration rate (eGFR) <20 mL/min/1.73 m2
  • An identified clinical disorder associated with skeletal muscle weakness/wasting (e.g., muscular dystrophy, mitochondrial disorder, active cancer, modified Rankin score greater or equal to 4 post-stroke)
  • Milk allergy, protein allergy, lactose intolerance, and galactosemia
  • Weight ≥350 pounds and/or BMI ≥40 kg/m2
  • Initiation of obesity-dosed GLP-1 or GIP/GLP-1 agonist within 3 months prior to screening, or clinical intention to begin such an anti-obesity medication within the next 6 months.

Treatment and study plan

Ensure Max Protein

Dietary Supplement

Ensure Max Protein, 1 bottle daily (330 mL), 30 grams protein

Ensure Original

Dietary Supplement

Ensure Original, 1 bottle daily (237 mL), 9 grams protein

Primary outcomes

  1. Appendicular Lean Mass (ALM)

    Time frame: 6 month study visit

    ALM as measured by dual X-ray absorptiometry (DXA)

Secondary outcomes

  1. Appendicular Lean Mass (ALM)

    Time frame: 3 month study visit

    ALM as measured by dual X-ray absorptiometry (DXA)

  2. Protein intake

    Time frame: 6 month study visit

    Dietary protein intake in g/kg/day, averaged over 3 days, which is calculated by entering recorded dietary intake from facilitate food record into the Food Processor® software

  3. Protein intake

    Time frame: 3 month study visit

    Dietary protein intake in g/kg/day, averaged over 3 days, which is calculated by entering recorded dietary intake from facilitated food record into the Food Processor® software

  4. Handgrip strength

    Time frame: 6 month study visit

    Strength in dominant hand assessed with 3 attempts using a hydraulic hand dynamometer in the dominant hand (Baseline® Evaluation Instruments Fabrication Enterprises Inc., Irvington NY) and the mean calculated

  5. Handgrip strength

    Time frame: 3 month study visit

    Strength in dominant hand assessed with 3 attempts using a hydraulic hand dynamometer in the dominant hand (Baseline® Evaluation Instruments Fabrication Enterprises Inc., Irvington NY) and the mean calculated

  6. 6-minute walk test (6MWT)

    Time frame: 6 month study visit

    6-minute walk test measured over 100-foot laps, with 0 feet assigned if no independent ambulation is possible

  7. 6-minute walk test (6MWT)

    Time frame: 3 month study visit

    6-minute walk test measured over 100-foot laps, with 0 feet assigned if no independent ambulation is possible

  8. Short physical performance battery (SPPB)

    Time frame: 6 months

    SPPB assesses balance, gait, strength, and endurance, by recording the ability to stand for up to 10 seconds with feet in the side-by-side, semi-tandem, and tandem positions; time to complete a 4-meter walk; and time to rise from a chair and return to the seated position 5 times

  9. Short physical performance battery (SPPB)

    Time frame: 3 months

    SPPB assesses balance, gait, strength, and endurance, by recording the ability to stand for up to 10 seconds with feet in the side-by-side, semi-tandem, and tandem positions; time to complete a 4-meter walk; and time to rise from a chair and return to the seated position 5 times

Other outcomes

  1. Fat free mass (FFM)

    Time frame: 6 months

    FFM as measured by dual X-ray absorptiometry (DXA)

  2. Fat free mass (FFM)

    Time frame: 3 months

    FFM as measured by dual X-ray absorptiometry (DXA)

  3. Fat mass (FM)

    Time frame: 6 months

    FM as measured by dual X-ray absorptiometry (DXA)

  4. Fat mass (FM)

    Time frame: 3 months

    FM as measured by dual X-ray absorptiometry (DXA)

  5. Weight

    Time frame: 6 months

    Bodyweight

  6. Weight

    Time frame: 3 months

    Bodyweight

  7. Simplified Nutritional Appetite Questionnaire (SNAQ)

    Time frame: 6 months

    Malnutrition risk assessment tool

  8. Simplified Nutritional Appetite Questionnaire (SNAQ)

    Time frame: 3 months

    Malnutrition risk assessment tool

  9. Mini-Nutritional Assessment-Short Form (MNA-SF)

    Time frame: 6 months

    Malnutrition risk assessment tool

  10. Mini-Nutritional Assessment-Short Form (MNA-SF)

    Time frame: 3 months

    Malnutrition risk assessment tool

  11. Subjective Global Assessment (SGA)

    Time frame: 6 months

    Semi-quantified assessment of cachexia per physical examination

  12. Subjective Global Assessment (SGA)

    Time frame: 3 months

    Semi-quantified assessment of cachexia per physical examination

  13. Growth Differentiation Factor (GDF)-15

    Time frame: 3 months

    Inflammatory and growth regulation cytokine blood concentration

  14. Growth Differentiation Factor (GDF)-15

    Time frame: 6 months

    Inflammatory and growth regulation cytokine blood concentration

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

    Time frame: 3 months

    Muscle growth regulation pathway blood concentrations

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

    Time frame: 6 months

    Muscle growth regulation pathway blood concentrations

Study contacts

Contact information is provided by the study sponsor or research team.

Amanda R Vest, MBBS

CONTACT

[email protected]

2164446798

Sponsors and collaborators

Lead sponsor

Tufts Medical Center

Other

Collaborators

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

Registry information

Acronym: ASTRID-HF

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Nov 25, 2022
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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