Mode
Text Size
Log in / Sign up
Phase 2 N=37 Randomized Double-blind Prevention

A Study of Muscle Strength Maintenance in Older Adults

Sarcopenia

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

Back to search