Back to resultsA SkeleTal Muscle Recovery Intervention With Dietary Protein in Heart Failure (ASTRID-HF)
Primary Purpose
Heart Failure, Muscle Atrophy
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ensure Max Protein
Ensure Original
Sponsored by
About this trial
This is an interventional supportive care trial for Heart Failure
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Sites / Locations
- Tufts Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
No Intervention
Arm Label
Experimental arm
Sham comparator arm
No intervention arm
Arm Description
30 g/day protein supplementation (1 Ensure Max Protein® bottle)
9 g/day protein supplementation (1 Ensure Original® bottle)
0 g/day protein supplementation (no Ensure bottles)
Outcomes
Primary Outcome Measures
Appendicular Lean Mass (ALM)
ALM as measured by dual X-ray absorptiometry (DXA)
Secondary Outcome Measures
Appendicular Lean Mass (ALM)
ALM as measured by dual X-ray absorptiometry (DXA)
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
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
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
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-minute walk test (6MWT)
6-minute walk test measured over 100-foot laps, with 0 feet assigned if no independent ambulation is possible
6-minute walk test (6MWT)
6-minute walk test measured over 100-foot laps, with 0 feet assigned if no independent ambulation is possible
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
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
Full Information
NCT ID
NCT05627440
First Posted
November 17, 2022
Last Updated
April 24, 2023
Sponsor
Tufts Medical Center
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT05627440
Brief Title
A SkeleTal Muscle Recovery Intervention With Dietary Protein in Heart Failure
Acronym
ASTRID-HF
Official Title
A SkeleTal Muscle Recovery Intervention With Dietary Protein in Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 24, 2023 (Actual)
Primary Completion Date
January 31, 2027 (Anticipated)
Study Completion Date
December 31, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tufts Medical Center
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Muscle Atrophy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental arm
Arm Type
Experimental
Arm Description
30 g/day protein supplementation (1 Ensure Max Protein® bottle)
Arm Title
Sham comparator arm
Arm Type
Active Comparator
Arm Description
9 g/day protein supplementation (1 Ensure Original® bottle)
Arm Title
No intervention arm
Arm Type
No Intervention
Arm Description
0 g/day protein supplementation (no Ensure bottles)
Intervention Type
Dietary Supplement
Intervention Name(s)
Ensure Max Protein
Intervention Description
Ensure Max Protein, 1 bottle daily (330 mL), 30 grams protein
Intervention Type
Dietary Supplement
Intervention Name(s)
Ensure Original
Intervention Description
Ensure Original, 1 bottle daily (237 mL), 9 grams protein
Primary Outcome Measure Information:
Title
Appendicular Lean Mass (ALM)
Description
ALM as measured by dual X-ray absorptiometry (DXA)
Time Frame
6 month study visit
Secondary Outcome Measure Information:
Title
Appendicular Lean Mass (ALM)
Description
ALM as measured by dual X-ray absorptiometry (DXA)
Time Frame
3 month study visit
Title
Protein intake
Description
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
Title
Protein intake
Description
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
Title
Handgrip strength
Description
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
Title
Handgrip strength
Description
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
3 month study visit
Title
6-minute walk test (6MWT)
Description
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
Title
6-minute walk test (6MWT)
Description
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
Title
Short physical performance battery (SPPB)
Description
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
Title
Short physical performance battery (SPPB)
Description
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
3 months
Other Pre-specified Outcome Measures:
Title
Fat free mass (FFM)
Description
FFM as measured by dual X-ray absorptiometry (DXA)
Time Frame
6 months
Title
Fat free mass (FFM)
Description
FFM as measured by dual X-ray absorptiometry (DXA)
Time Frame
3 months
Title
Fat mass (FM)
Description
FM as measured by dual X-ray absorptiometry (DXA)
Time Frame
6 months
Title
Fat mass (FM)
Description
FM as measured by dual X-ray absorptiometry (DXA)
Time Frame
3 months
Title
Weight
Description
Bodyweight
Time Frame
6 months
Title
Weight
Description
Bodyweight
Time Frame
3 months
Title
Simplified Nutritional Appetite Questionnaire (SNAQ)
Description
Malnutrition risk assessment tool
Time Frame
6 months
Title
Simplified Nutritional Appetite Questionnaire (SNAQ)
Description
Malnutrition risk assessment tool
Time Frame
3 months
Title
Mini-Nutritional Assessment-Short Form (MNA-SF)
Description
Malnutrition risk assessment tool
Time Frame
6 months
Title
Mini-Nutritional Assessment-Short Form (MNA-SF)
Description
Malnutrition risk assessment tool
Time Frame
3 months
Title
Subjective Global Assessment (SGA)
Description
Semi-quantified assessment of cachexia per physical examination
Time Frame
6 months
Title
Subjective Global Assessment (SGA)
Description
Semi-quantified assessment of cachexia per physical examination
Time Frame
3 months
Title
Growth Differentiation Factor (GDF)-15
Description
Inflammatory and growth regulation cytokine blood concentration
Time Frame
3 months
Title
Growth Differentiation Factor (GDF)-15
Description
Inflammatory and growth regulation cytokine blood concentration
Time Frame
6 months
Title
Activin A and Follistatin-related gene (FSTL)-3
Description
Muscle growth regulation pathway blood concentrations
Time Frame
3 months
Title
Activin A and Follistatin-related gene (FSTL)-3
Description
Muscle growth regulation pathway blood concentrations
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Facility Information:
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivia Lovegreen
Phone
617-636-5000
Email
OLovegreen@tuftsmedicalcenter.org
First Name & Middle Initial & Last Name & Degree
Amanda R Vest, MBBS
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data sharing plans will be reviewed by the Tufts Health Sciences IRB and no identifiable participant data will be shared outside Tufts Medical Center. A data use agreement (DUA) will be completed between the PI and collaborating sites.
IPD Sharing Time Frame
After primary and secondary analyses have been completed and the major findings for each Aim accepted for publication.
IPD Sharing Access Criteria
Due to the small sample size and single center location of the subjects, there remains a potential for deductive disclosure of subjects with unique clinical characteristics. Thus, the DUA will include language requiring: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.
Learn more about this trial
A SkeleTal Muscle Recovery Intervention With Dietary Protein in Heart Failure
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