Phase 2
N=37
A Study of Muscle Strength Maintenance in Older Adults
Sarcopenia
Bottom Line
View on ClinicalTrials.gov: NCT01989793 ↗Enrolled (actual)
37
Serious AEs
2.7%
Results posted
Jun 2018
Primary outcome: Primary: Change From Baseline in Isokinetic Strength — -4.90; -4.73 Newton — p=0.97
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Losartan (Drug); Placebo (Drug)
- Age
- Older Adult · 70+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- Oct 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Isokinetic Strength |
-9.20; -7.00 | 0.59 |
| PRIMARY Change From Baseline in Isokinetic Strength |
-9.20; -7.00 | 0.59 |
| PRIMARY Change From Baseline in Isokinetic Strength |
-9.20; -7.00 | 0.59 |
| PRIMARY Fatiguability |
17.07; 9.05 | 0.203 |
| PRIMARY Fatiguability |
17.07; 9.05 | 0.203 |
| PRIMARY Fatiguability |
17.07; 9.05 | 0.203 |
| SECONDARY Number of Participants Experiencing Any Amount of Decrease in Frailty |
3; 5 | 0.73 |
| SECONDARY Number of Participants Experiencing Any Amount of Decrease in Frailty |
3; 5 | 0.73 |
| SECONDARY Number of Participants Experiencing Any Amount of Decrease in Frailty |
3; 5 | 0.73 |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01989793). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.