Status:
TERMINATED
Phase 1/2 Prospective Double-Blind Placebo-Controlled Randomized Clinical Trial of Losartan to Treat Grade II & III Hamstring Strains
Lead Sponsor:
James J. Irrgang
Collaborating Sponsors:
Brooke Army Medical Center
Wake Forest University
Conditions:
Hamstring Injury
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 ha...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 18 years of age and older;
- Have had grade II or III hamstring injury within the 7 days prior to enrollment;
- 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;
- Agree to take study medications as prescribed
- Exclusion Criteria:
- Have had previous hamstring injury on the same side or chronic symptoms;
- Have an injury that requires surgical intervention (e.g. avulsion with associated bony involvement, grade III complete tears);
- Have concurrent lower back symptoms;
- Pregnant or breast feeding;
- Is a smoker;
- Has contraindications for Losartan therapy (hypersensitivity to Losartan, hepatic involvement);
- Currently use angiotensin I converting enzyme inhibitor (ACEI)/ Angiotensin II receptor blocker (ARB);
- Have hypertension (blood pressure greater than or equal to 140 mmHg systolic pressure or greater than or equal to 90 mmHg diastolic pressure);
- Have hypotension (blood pressure less than or equal to 90 mmHg systolic pressure or less than or equal to 60 mmHg diastolic pressure);
- 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;
- Have diabetes mellitus, cardiovascular, renal or hepatic co-morbidities;
- Sickle cell anemia/trait;
- 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
Exclusion
Key Trial Info
Start Date :
August 10 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2022
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT02263729
Start Date
August 10 2016
End Date
December 31 2022
Last Update
May 2 2024
Active Locations (1)
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1
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213