A Study of Muscle Strength Maintenance in Older Adults
| Status: | Completed |
|---|---|
| Conditions: | Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 70 - 100 |
| Updated: | 6/14/2018 |
| Start Date: | July 2013 |
| End Date: | October 2016 |
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.
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.
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.
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.
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
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