ASTRID-HF: A SkeleTal Muscle Recovery Intervention With Dietary Protein in Heart Failure
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Experimental arm 30 g/day protein supplementation (1 Ensure Max Protein® bottle) |
Dietary Supplement: Ensure Max Protein
Ensure Max Protein, 1 bottle daily (330 mL), 30 grams protein
|
| Active Comparator: Sham comparator arm 9 g/day protein supplementation (1 Ensure Original® bottle) |
Dietary Supplement: Ensure Original
Ensure Original, 1 bottle daily (237 mL), 9 grams protein
|
| No Intervention: No intervention arm 0 g/day protein supplementation (no Ensure bottles) |
Outcome Measures
Primary Outcome Measures
- Appendicular Lean Mass (ALM) [6 month study visit]
ALM as measured by dual X-ray absorpiometry (DXA)
Secondary Outcome Measures
- Appendicular Lean Mass (ALM) [3 month study visit]
ALM as measured by dual X-ray absorpiometry (DXA)
- Protein intake [6 month study visit]
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 [3 month study visit]
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 [6 month study visit]
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 [3 month study visit]
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 month study visit]
6-minute walk test measured over 100-foot laps, with 0 feet assigned if no independent ambulation is possible
- 6-minute walk test (6MWT) [3 month study visit]
6-minute walk test measured over 100-foot laps, with 0 feet assigned if no independent ambulation is possible
- Short physical performance battery (SPPB) [6 months]
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) [3 months]
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
Other Outcome Measures
- Fat free mass (FFM) [6 months]
FFM as measured by dual X-ray absorpiometry (DXA)
- Fat free mass (FFM) [3 months]
FFM as measured by dual X-ray absorpiometry (DXA)
- Fat mass (FM) [6 months]
FM as measured by dual X-ray absorpiometry (DXA)
- Fat mass (FM) [3 months]
FM as measured by dual X-ray absorpiometry (DXA)
- Weight [6 months]
Bodyweight
- Weight [3 months]
Bodyweight
- Simplified Nutritional Appetite Questionnaire (SNAQ) [6 months]
Malnutrition risk assessment tool
- Simplified Nutritional Appetite Questionnaire (SNAQ) [3 months]
Malnutrition risk assessment tool
- Mini-Nutritional Assessment-Short Form (MNA-SF) [6 months]
Malnutrition risk assessment tool
- Mini-Nutritional Assessment-Short Form (MNA-SF) [3 months]
Malnutrition risk assessment tool
- Subjective Global Assessment (SGA) [6 months]
Semi-quantified assessment of cachexia per physical examination
- Subjective Global Assessment (SGA) [3 months]
Semi-quantified assessment of cachexia per physical examination
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Left ventricular ejection fraction (LVEF) ≤40%, New York Heart Association (NHYA) class II to IV symptoms or NT-proBNP >300 pg/mL
-
Age 18 years to 100 years, inclusive
-
Any of the following markers of severe HF within prior 12 months: i) Inotropic therapy; ii) 1+ HF hospitalizations; iii) LVEF ≤25%; iv) Peak 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 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 4+ post-stroke)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Tufts Medical Center | Boston | Massachusetts | United States | 02111 |
Sponsors and Collaborators
- Tufts Medical Center
- National Heart, Lung, and Blood Institute (NHLBI)
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STUDY00003095