Heart FailureASTRID-HFNCT05627440
A SkeleTal Muscle Recovery Intervention With Dietary Protein in Heart Failure
A study testing Ensure Max Protein and Ensure Original in people with Heart Failure and Muscle Atrophy, run by Tufts Medical Center at 2 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Heart Failure, Muscle Atrophy
- What is being tested?
- Ensure Max Protein and Ensure Original
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesUnited States
- Study dates
- 24 Apr 2023to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
- Weight ≥350 pounds and/or BMI ≥40 kg/m2
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Tufts Medical Center
Boston, Massachusetts, 02111
Olivia Lovegreen, 617-636-5000, OLovegreen@tuftsmedicalcenter.org
Indranee N Rajapreyar, MD
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Teresa Fonk
Amanda R Vest, MBBS
About this study
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.
- Conditions
- Heart Failure, Muscle Atrophy
- Being tested
- Ensure Max Protein, Ensure Original
- Medical subject headings
- Heart Failure, Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ensure Max ProteinDietary supplement
Ensure Max Protein, 1 bottle daily (330 mL), 30 grams protein
Ensure OriginalDietary supplement
Ensure Original, 1 bottle daily (237 mL), 9 grams protein
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | 30 g/day protein supplementation (1 Ensure Max Protein® bottle) Receives: Dietary Supplement: Ensure Max Protein |
| Sham comparator arm | Active comparator | 9 g/day protein supplementation (1 Ensure Original® bottle) Receives: Dietary Supplement: Ensure Original |
| No intervention arm | No intervention | 0 g/day protein supplementation (no Ensure bottles) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Appendicular Lean Mass (ALM)
ALM as measured by dual X-ray absorptiometry (DXA)
Measured: 6 month study visit
Secondary outcomes (9)
Appendicular Lean Mass (ALM)
ALM as measured by dual X-ray absorptiometry (DXA)
Measured: 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
Measured: 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
Measured: 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
Measured: 6 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
Measured: 3 month study visit
6-minute walk test (6MWT)
6-minute walk test measured over 100-foot laps, with 0 feet assigned if no independent ambulation is possible
Measured: 6 month study visit
6-minute walk test (6MWT)
6-minute walk test measured over 100-foot laps, with 0 feet assigned if no independent ambulation is possible
Measured: 3 month study visit
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
Measured: 6 months
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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2022
- Study start24 Apr 2023
- Primary completion1 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tufts Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05627440
- Sponsor's protocol ID
- STUDY00003095
- Other IDs
- 1R01HL167113-01
- Acronym
- ASTRID-HF
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2022
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A SkeleTal Muscle Recovery Intervention With Dietary Protein in Heart Failure
- ClinicalTrials.gov ID
- NCT05627440
- Acronym / sponsor ID
- ASTRID-HF / STUDY00003095
- Conditions
- Heart Failure, Muscle Atrophy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Tufts Medical CenterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 24 Apr 2023 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 25 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Dietary Supplement: Ensure Max Protein30 g/day protein supplementation (1 Ensure Max Protein® bottle) |
| Sham comparator arm | Active comparator | Dietary Supplement: Ensure Original9 g/day protein supplementation (1 Ensure Original® bottle) |
| No intervention arm | No intervention | –0 g/day protein supplementation (no Ensure bottles) |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
- Weight ≥350 pounds and/or BMI ≥40 kg/m2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ensure Max ProteinEnsure Max Protein, 1 bottle daily (330 mL), 30 grams protein | Dietary supplement | Experimental arm |
| Ensure OriginalEnsure Original, 1 bottle daily (237 mL), 9 grams protein | Dietary supplement | Sham comparator arm |
Primary outcome
Appendicular Lean Mass (ALM)
Time frame: 6 month study visit
ALM as measured by dual X-ray absorptiometry (DXA)
9 secondary outcomes
Appendicular Lean Mass (ALM)
Time frame: 3 month study visit
Protein intake
Time frame: 6 month study visit
Protein intake
Time frame: 3 month study visit
Handgrip strength
Time frame: 6 month study visit
Handgrip strength
Time frame: 3 month study visit
6-minute walk test (6MWT)
Time frame: 6 month study visit
6-minute walk test (6MWT)
Time frame: 3 month study visit
Short physical performance battery (SPPB)
Time frame: 6 months
Short physical performance battery (SPPB)
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ensure Max Protein and Ensure Original in people with Heart Failure and Muscle Atrophy, run by Tufts Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amanda R Vest, MBBS (2164446798, vesta2@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Appendicular Lean Mass (ALM) (time frame: 6 month study visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.