A SkeleTal Muscle Recovery Intervention With Dietary Protein in Heart Failure

Tufts Medical Center120 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

120

Conditions

Heart Failure Muscle Atrophy

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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 6. 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.

Outcomes

Primary Outcomes

Appendicular Lean Mass (ALM)

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

Time frame: 6 month study visit

Secondary Outcomes

Appendicular Lean Mass (ALM)

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

Time frame: 3 month study visit

Protein intake

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

Time frame: 6 month study visit

Protein intake

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

Time frame: 3 month study visit

Handgrip strength

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

Time frame: 6 month study visit

Handgrip strength

Time frame: 3 month study visit

6-minute walk test (6MWT)

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

Time frame: 6 month study visit

6-minute walk test (6MWT)

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

Time frame: 3 month study visit

Short physical performance battery (SPPB)

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

Time frame: 6 months

Short physical performance battery (SPPB)

Time frame: 3 months

A SkeleTal Muscle Recovery Intervention With Dietary Protein in Heart Failure

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts