A Study of Muscle Strength Maintenance in Older Adults
Condition: Sarcopenia
MeSH terms: Sarcopenia
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    

Detailed description: 
      The loss of independence in older adults is among the most costly and disturbing events in
      the life span. This loss is often influenced by multiple etiologies, including medical and
      neurological conditions, cognitive decline, non-supportive social/environmental settings and
      frailty. Frailty is a syndrome of multi-systemic, age-related decline characterized by
      weakness, weight loss, fatigue, low levels of activity, and slowness. Frail older adults have
      a higher risk for adverse outcomes including hospitalization, disability, and mortality.

      Recently, Johns Hopkins University Older Americans Independence Center (JHU OAIC)
      investigators Burks and Cohn found that blocking angiotensin type 1 receptors with losartan,
      an angiotensin-receptor blocker (ARB) in older mice markedly accelerated injured skeletal
      muscle healing and decreased vulnerability to disuse atrophy and strength decline. These
      findings provide potent rationale for testing the hypothesis that losartan attenuates
      strength decline and other-frailty related measures in older adults.

      To prepare to test this hypothesis, a phase 2 randomized, placebo controlled pilot clinical
      trial of losartan in pre-frail adults over age 70 is proposed that aims to assess safety and
      tolerability, estimate dosing range, and estimate treatment effects using inter- and
      intra-subject variability of potential outcome measures. Losartan is a medication that is
      commonly utilized in older adults for the treatment of hypertension and is generally well
      tolerated in that condition and in other cardiovascular conditions.

      The study will take place over 24 weeks in the Clinical Research Unit (CRU) on the Hopkins
      Bayview Medical Campus, where 24 pre-frail subjects will be recruited from the OAIC frailty
      registry. Successful completion of this study will provide the safety, dosing, and outcome
      measure data necessary to design the pivotal study needed to determine if longer term
      treatment with losartan can significantly improve frailty and related skeletal muscle
      phenotypes.

      Interventions, such as losartan, that can prevent the decline seen in frailty have the
      potential to improve function and help older adults maintain their independence. This is of
      the utmost importance in maintaining good quality-of-life for older adults.
    

Intervention name(s): Losartan; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Losartan will be given in increasing doses to those in the losartan arm.; Placebo will be given to those in placebo arm
Intervention MeSH terms: Losartan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: sarcopenia; frailty; losartan