A SkeleTal Muscle Recovery Intervention With Dietary Protein in Heart Failure

NCT05627440 | Recruiting DMC

• 2 other identifiers: STUDY000030951R01HL167113-01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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.

Conditions

Heart Failure; Muscle Atrophy

Outcome Measures

Primary Outcomes (1)

• Appendicular Lean Mass (ALM)

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

  6 month study visit

Secondary Outcomes (9)

• Appendicular Lean Mass (ALM)

  3 month study visit

• Protein intake

  6 month study visit

• Protein intake

  3 month study visit

• Handgrip strength

  6 month study visit

• Handgrip strength

  3 month study visit

Other Outcomes (16)

• Fat free mass (FFM)

  6 months

• Fat free mass (FFM)

  3 months

• Fat mass (FM)

  6 months

Study Arms (3)

Experimental arm

EXPERIMENTAL

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

Dietary Supplement: Ensure Max Protein

Sham comparator arm

ACTIVE COMPARATOR

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

Dietary Supplement: Ensure Original

No intervention arm

NO INTERVENTION

0 g/day protein supplementation (no Ensure bottles)

Interventions

Ensure Max Protein DIETARY_SUPPLEMENT

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

Experimental arm

Ensure Original DIETARY_SUPPLEMENT

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

Sham comparator arm

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tufts Medical Center: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (2)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

RECRUITING

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

MeSH Terms

Conditions

Heart Failure; Muscular Atrophy

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Amanda R Vest, MBBS

CONTACT

2164446798; vesta2@ccf.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2022
• First Posted: November 25, 2022
• Study Start: April 24, 2023
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• 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.

Locations

US (2)