A SkeleTal Muscle Recovery Intervention With Dietary Protein in Heart Failure

Heart Failure Clinical Trial

— ASTRID-HF  

Official title:

A SkeleTal Muscle Recovery Intervention With Dietary Protein in Heart Failure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05627440
• Other study ID #: STUDY00003095
• Secondary ID: 1R01HL167113-01
• Status: Recruiting
• Phase: N/A
• Start date: April 24, 2023
• Est. completion date: December 31, 2027

Study information

• Verified date: November 2023
• Source: Tufts Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2027
• Est. primary completion date: January 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Heart Failure
• Muscle Atrophy
• Muscular Atrophy

Intervention

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

Locations

Country	Name	City	State
United States	Tufts Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Tufts Medical Center	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Fat free mass (FFM)	FFM as measured by dual X-ray absorptiometry (DXA)	6 months
Other	Fat free mass (FFM)	FFM as measured by dual X-ray absorptiometry (DXA)	3 months
Other	Fat mass (FM)	FM as measured by dual X-ray absorptiometry (DXA)	6 months
Other	Fat mass (FM)	FM as measured by dual X-ray absorptiometry (DXA)	3 months
Other	Weight	Bodyweight	6 months
Other	Weight	Bodyweight	3 months
Other	Simplified Nutritional Appetite Questionnaire (SNAQ)	Malnutrition risk assessment tool	6 months
Other	Simplified Nutritional Appetite Questionnaire (SNAQ)	Malnutrition risk assessment tool	3 months
Other	Mini-Nutritional Assessment-Short Form (MNA-SF)	Malnutrition risk assessment tool	6 months
Other	Mini-Nutritional Assessment-Short Form (MNA-SF)	Malnutrition risk assessment tool	3 months
Other	Subjective Global Assessment (SGA)	Semi-quantified assessment of cachexia per physical examination	6 months
Other	Subjective Global Assessment (SGA)	Semi-quantified assessment of cachexia per physical examination	3 months
Other	Growth Differentiation Factor (GDF)-15	Inflammatory and growth regulation cytokine blood concentration	3 months
Other	Growth Differentiation Factor (GDF)-15	Inflammatory and growth regulation cytokine blood concentration	6 months
Other	Activin A and Follistatin-related gene (FSTL)-3	Muscle growth regulation pathway blood concentrations	3 months
Other	Activin A and Follistatin-related gene (FSTL)-3	Muscle growth regulation pathway blood concentrations	6 months
Primary	Appendicular Lean Mass (ALM)	ALM as measured by dual X-ray absorptiometry (DXA)	6 month study visit
Secondary	Appendicular Lean Mass (ALM)	ALM as measured by dual X-ray absorptiometry (DXA)	3 month study visit
Secondary	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	6 month study visit
Secondary	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	3 month study visit
Secondary	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	6 month study visit
Secondary	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	3 month study visit
Secondary	6-minute walk test (6MWT)	6-minute walk test measured over 100-foot laps, with 0 feet assigned if no independent ambulation is possible	6 month study visit
Secondary	6-minute walk test (6MWT)	6-minute walk test measured over 100-foot laps, with 0 feet assigned if no independent ambulation is possible	3 month study visit
Secondary	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	6 months
Secondary	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	3 months