A SkeleTal Muscle Recovery Intervention With Dietary Protein in Heart Failure

ConditionsHeart Failure Muscle Atrophy

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-100

SponsorTufts Medical Center

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Ensure Max Protein
Dietary supplement
Ensure Max Protein, 1 bottle daily (330 mL), 30 grams protein
Ensure Original
Dietary supplement
Ensure Original, 1 bottle daily (237 mL), 9 grams protein

Treatment groups

120 Participants

are divided into 3 treatment groups

Group A: Experimental armExperimental treatment 1 intervention

Group B: Sham comparator armActive comparator 1 intervention

Group C: No intervention armNo intervention 0 interventions

Trial 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

Other outcomes

Fat free mass (FFM)

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

Time frame

6 months

Fat free mass (FFM)

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

Time frame

3 months

Fat mass (FM)

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

Time frame

6 months

Fat mass (FM)

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

Time frame

3 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tufts Medical Center

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Source ClinicalTrials.gov

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