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A SkeleTal Muscle Recovery Intervention With Dietary Protein in Heart Failure (ASTRID-HF)

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ClinicalTrials.gov Identifier: NCT05627440
Recruitment Status : Not yet recruiting
First Posted : November 25, 2022
Last Update Posted : November 25, 2022
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Tufts Medical Center

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Heart Failure Muscle Atrophy Dietary Supplement: Ensure Max Protein Dietary Supplement: Ensure Original Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A SkeleTal Muscle Recovery Intervention With Dietary Protein in Heart Failure
Estimated Study Start Date : January 16, 2023
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Experimental arm
30 g/day protein supplementation (1 Ensure Max Protein® bottle)
 Dietary Supplement: Ensure Max Protein
Ensure Max Protein, 1 bottle daily (330 mL), 30 grams protein
Active Comparator: Sham comparator arm
9 g/day protein supplementation (1 Ensure Original® bottle)
 Dietary Supplement: Ensure Original
Ensure Original, 1 bottle daily (237 mL), 9 grams protein
No Intervention: No intervention arm
0 g/day protein supplementation (no Ensure bottles)


Outcome Measures
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Primary Outcome Measures :
  1. Appendicular Lean Mass (ALM) [ Time Frame: 6 month study visit ]
    ALM as measured by dual X-ray absorpiometry (DXA)


Secondary Outcome Measures :
  1. Appendicular Lean Mass (ALM) [ Time Frame: 3 month study visit ]
    ALM as measured by dual X-ray absorpiometry (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 Outcome Measures:
  1. Fat free mass (FFM) [ Time Frame: 6 months ]
    FFM as measured by dual X-ray absorpiometry (DXA)

  2. Fat free mass (FFM) [ Time Frame: 3 months ]
    FFM as measured by dual X-ray absorpiometry (DXA)

  3. Fat mass (FM) [ Time Frame: 6 months ]
    FM as measured by dual X-ray absorpiometry (DXA)

  4. Fat mass (FM) [ Time Frame: 3 months ]
    FM as measured by dual X-ray absorpiometry (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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Left ventricular ejection fraction (LVEF) ≤40%, New York Heart Association (NHYA) class II to IV symptoms or NT-proBNP >300 pg/mL
  2. Age 18 years to 100 years, inclusive
  3. Any of the following markers of severe HF within prior 12 months: 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 weight loss >5% of bodyweight over the past year; vii) Moderate or severe muscle wasting on physical examination

Exclusion Criteria:

  1. Pregnancy, planning to become pregnant, or women of reproductive potential unwilling to complete pre-DXA urine pregnancy test before first DXA or randomization
  2. History of LVAD, heart transplantation, or estimated glomerular filtration rate (eGFR) <20 mL/min/1.73 m2
  3. An identified clinical disorder associated with skeletal muscle weakness/wasting (e.g., muscular dystrophy, mitochondrial disorder, active cancer, modified Rankin score 4+ post-stroke)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05627440


Locations
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United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Contact: Olivia Lovegreen       OLovegreen@tuftsmedicalcenter.org   
Principal Investigator: Amanda R Vest, MBBS         
Sponsors and Collaborators
Tufts Medical Center
National Heart, Lung, and Blood Institute (NHLBI)
More Information
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Responsible Party: Tufts Medical Center
ClinicalTrials.gov Identifier: NCT05627440    
Other Study ID Numbers: STUDY00003095
First Posted: November 25, 2022    Key Record Dates
Last Update Posted: November 25, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data sharing plans will be reviewed by the Tufts Health Sciences IRB and no identifiable participant data will be shared outside Tufts Medical Center. A data use agreement (DUA) will be completed between the PI and collaborating sites.
Time Frame: After primary and secondary analyses have been completed and the major findings for each Aim accepted for publication.
Access Criteria: Due to the small sample size and single center location of the subjects, there remains a potential for deductive disclosure of subjects with unique clinical characteristics. Thus, the DUA will include language requiring: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Muscular Atrophy
Heart Failure
Heart Diseases
Cardiovascular Diseases
Atrophy
 Pathological Conditions, Anatomical
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases