Sarcopenia | A Study of Muscle Strength Maintenance in Older Adults
Sarcopenia research study
What is the primary objective of this study?
This research study is being done to see whether losartan can prevent the decrease in strength associated with aging. Muscle loss is associated with aging and has multiple symptoms such as weakness, slowness, and fatigue (tiredness). Older adults with muscle weakness have a higher risk of falls and disability. In addition, the loss of independence for older adults can lead to a poorer quality of life. Recently, it was discovered that losartan, a medication commonly used to treat high blood pressure, had slowed the strength decline seen in older mice. In addition, it allowed injured mice skeletal muscle to heal faster. Therefore, we would like to see if losartan can do the same for older adults. Losartan is approved by the Food and Drug Administration (FDA) for the treatment of high blood pressure, heart failure, and to protect the kidneys in diabetic patients. Losartan is not FDA-approved to prevent the decrease in strength associated with aging. In this study, participants age 70 and older will be asked to take losartan or a placebo to see if losartan can help prevent loss of muscle strength. A placebo is a substance that looks like the study drug but that contains no active ingredients.
Who is eligible to participate?
Inclusion Criteria: - Age 70 and over - Pre-frail as determined by frailty criteria Exclusion Criteria: - Under age 70 - Robust or frail by frailty criteria - Have other indications for use of any angiotensin-receptor blockers (ARB) such as myocardial infarction in past year, history of congestive heart failure, uncontrolled hypertension - Current use of ARBs or angiotensin-converting enzyme (ACE) inhibitors - Prior allergic reaction to or hyperkalemia with losartan or any ARB - Chronic renal failure with a glomerular filtration rate of < 30 - Current daily use of non-steroidal anti-inflammatory agents - Current use of steroids - Lower extremity disability that would prevent muscle strength testing - Echocardiogram-diagnosed cardiac failure as evidenced by left ventricular ejection fraction less than 50% - Cognitive impairment with a Mini-Mental State Examination < 24
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:LosartanLosartan will be given in increasing doses to those in the losartan arm.
Drug:PlaceboPlacebo will be given to those in placebo arm
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
LosartanFor those subjects randomized to the losartan group, they will receive losartan 25mg by mouth daily for 8 weeks, then increase to 50mg by mouth daily for another 8 weeks, then increase to 100mg by mouth daily for a final 8 weeks.
PlaceboFor those subjects randomized to placebo, they will receive a placebo to take for 24 weeks total.
Start Date: July 2013
Completed Date: October 2016
Phase: Phase 2
Primary Outcome: Change from baseline in isokinetic strength and fatigability
Secondary Outcome: Change from baseline in frailty status
Study sponsors, principal investigator, and references
Principal Investigator: Jeremy Walston, MD
Lead Sponsor: Johns Hopkins University
Collaborator: National Institutes of Health (NIH)
Burks TN, Andres-Mateos E, Marx R, Mejias R, Van Erp C, Simmers JL, Walston JD, Ward CW, Cohn RD. Losartan restores skeletal muscle remodeling and protects against disuse atrophy in sarcopenia. Sci Transl Med. 2011 May 11;3(82):82ra37. doi: 10.1126/scitranslmed.3002227.