Clinical trial NCT05627440: A SkeleTal Muscle Recovery Intervention with Dietary Protein in Heart Failure
Official title: A SkeleTal Muscle Recovery Intervention with Dietary Protein in Heart Failure
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure
Muscle Atrophy
Lead sponsor: Tufts Medical Center
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2022-11-25
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Appendicular Lean Mass (ALM)
timeFrame: 6 month study visit
Secondary outcomes:
measure: Appendicular Lean Mass (ALM)
timeFrame: 3 month study visit
measure: Protein intake
timeFrame: 6 month study visit
measure: Protein intake
timeFrame: 3 month study visit
measure: Handgrip strength
timeFrame: 6 month study visit
measure: Handgrip strength
timeFrame: 3 month study visit
measure: 6-minute walk test (6MWT)
timeFrame: 6 month study visit
measure: 6-minute walk test (6MWT)
timeFrame: 3 month study visit
measure: Short physical performance battery (SPPB)
timeFrame: 6 months
measure: Short physical performance battery (SPPB)
timeFrame: 3 months
Other outcomes:
measure: Fat free mass (FFM)
timeFrame: 6 months
measure: Fat free mass (FFM)
timeFrame: 3 months
measure: Fat mass (FM)
timeFrame: 6 months
measure: Fat mass (FM)
timeFrame: 3 months
measure: Weight
timeFrame: 6 months
measure: Weight
timeFrame: 3 months
measure: Simplified Nutritional Appetite Questionnaire (SNAQ)
timeFrame: 6 months
measure: Simplified Nutritional Appetite Questionnaire (SNAQ)
timeFrame: 3 months
measure: Mini-Nutritional Assessment-Short Form (MNA-SF)
timeFrame: 6 months
measure: Mini-Nutritional Assessment-Short Form (MNA-SF)
timeFrame: 3 months
measure: Subjective Global Assessment (SGA)
timeFrame: 6 months
measure: Subjective Global Assessment (SGA)
timeFrame: 3 months
measure: Growth Differentiation Factor (GDF)-15
timeFrame: 3 months
measure: Growth Differentiation Factor (GDF)-15
timeFrame: 6 months
measure: Activin A and Follistatin-related gene (FSTL)-3
timeFrame: 3 months
measure: Activin A and Follistatin-related gene (FSTL)-3
timeFrame: 6 months
Locations:
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
References: