Phase 1/2 Prospective Double-blind, Placebo-controlled Randomized Clinical Trial Using Losartan to Treat Grade II and III Hamstring Strains



Status:Recruiting
Healthy:No
Age Range:18 - 35
Updated:12/12/2018
Start Date:July 2016
End Date:December 31, 2019
Contact:James Irrgang, PT,PhD
Email:jirrgang@pitt.edu

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The goal of this study is to determine safety and tolerability of Losartan when used for
treatment of an acute grade II or III hamstring strain and determining the effect of losartan
on recovery of hamstring muscle function. Subjects will be adults age 18-35 with grade 2 or 3
hamstring injury who participate in Level 1 athletics or have a similar physical work load
(e.g. military personnel). Military personnel will only be recruited at Brookings Medical
Institute. Subjects will undergo examination, MRI, and functional assessment before, during,
and after 4 weeks of losartan (50mg QD) or placebo.


Inclusion Criteria

1. 18 years of age and older;

2. Have had grade II or III hamstring injury within the 7 days prior to enrollment;

3. Greater than 100 hours per year in Level I (football, basketball, or soccer) or Level
II (racquet sports, skiing, manual labor occupations/heavy physical work) and
activities that require running and sprinting;

4. Agree to take study medications as prescribed

Exclusion Criteria:

1. Have had previous hamstring injury on the same side or chronic symptoms;

2. Have an injury that requires surgical intervention (e.g. avulsion with associated bony
involvement, grade III complete tears);

3. Have concurrent lower back symptoms;

4. Pregnant or breast feeding;

5. Is a smoker;

6. Has contraindications for Losartan therapy (hypersensitivity to Losartan, hepatic
involvement);

7. Currently use angiotensin I converting enzyme inhibitor (ACEI)/ Angiotensin II
receptor blocker (ARB);

8. Have hypertension (blood pressure greater than or equal to 140 mmHg systolic pressure
or greater than or equal to 90 mmHg diastolic pressure);

9. Have hypotension (blood pressure less than or equal to 90 mmHg systolic pressure or
less than or equal to 60 mmHg diastolic pressure);

10. Have orthostatic hypotension defined as a drop in systolic pressure greater than or
equal to 2 0mmHg or a drop in diastolic blood pressure greater than or equal to 10
mmHg or reports of lightheadedness or dizziness upon standing;

11. Have diabetes mellitus, cardiovascular, renal or hepatic co-morbidities;

12. Have contraindications for MRI - including:

- Prior surgery for an aneurysm;

- Have cardiac pacemaker;

- Have metal fragments in the eyes, brain, or spinal cord from shrapnel, metal
work, or welding;

- Have surgical implants, such as ear implant or neurostimulator;

- Have a history of claustrophobia;

- Have a history of not tolerating previous MRI scans without medication
We found this trial at
1
site
4200 Fifth Ave
Pittsburgh, Pennsylvania 15260
(412) 624-4141
Principal Investigator: James Irrgang, PT, PhD
University of Pittsburgh The University of Pittsburgh is a state-related research university, founded as the...
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