A SkeleTal Muscle Recovery Intervention with Dietary Protein in Heart Failure

Not Applicable

Recruiting

• Conditions: Heart Failure; Muscle Atrophy
• Interventions: Dietary Supplement: Ensure Max Protein; Dietary Supplement: Ensure Original

• Registration Number: NCT05627440
• Lead Sponsor: Tufts Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-17
• Study First Submitted QC: 2022-11-17
• Study First Posted: 2022-11-25
• Study Start: 2023-04-24
• Status Verified: 2024-08
• Last Update Submitted: 2024-12-12
• Last Update Posted: 2024-12-17
• Primary Completion: 2027-01-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. 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
2. Age 18 years to 100 years, inclusive
3. Receiving guideline-directed medical therapy (GDMT), unless contraindicated or not tolerated
4. 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

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 left ventricular assist device (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 greater or equal to 4 post-stroke)
4. Milk allergy, protein allergy, lactose intolerance, and galactosemia
5. Weight ≥350 pounds and/or BMI ≥40 kg/m2

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental arm	Ensure Max Protein	30 g/day protein supplementation (1 Ensure Max Protein® bottle)
Sham comparator arm	Ensure Original	9 g/day protein supplementation (1 Ensure Original® bottle)

Primary Outcome Measures

Name	Time	Method
Appendicular Lean Mass (ALM)	6 month study visit	ALM as measured by dual X-ray absorptiometry (DXA)

Secondary Outcome Measures

Name	Time	Method
Appendicular Lean Mass (ALM)	3 month study visit	ALM as measured by dual X-ray absorptiometry (DXA)
Protein intake	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
6-minute walk test (6MWT)	3 month study visit	6-minute walk test measured over 100-foot laps, with 0 feet assigned if no independent ambulation is possible
Handgrip strength	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
Short physical performance battery (SPPB)	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

Trial Locations

Locations (2)

Tufts Medical Center; 🇺🇸 Boston, Massachusetts, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States