A SkeleTal Muscle Recovery Intervention With Dietary Protein in Heart Failure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-24

Study Completion Date

2027-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Heart Failure Muscle Atrophy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Experimental arm

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

Group Type EXPERIMENTAL

Ensure Max Protein

Intervention Type DIETARY_SUPPLEMENT

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

Sham comparator arm

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

Group Type ACTIVE_COMPARATOR

Ensure Original

Intervention Type DIETARY_SUPPLEMENT

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

No intervention arm

0 g/day protein supplementation (no Ensure bottles)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Ensure Max Protein

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

Intervention Type DIETARY_SUPPLEMENT

Ensure Original

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No