Clinical trial NCT02263729: Phase 1/2 Prospective Double-Blind Placebo-Controlled Randomized Clinical Trial of Losartan to Treat Grade II & III Hamstring Strains
Official title: Phase 1/2 Prospective Double-blind, Placebo-controlled Randomized Clinical Trial Using Losartan to Treat Grade II and III Hamstring Strains
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Hamstring Injury
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Brooke Army Medical Center
name: Wake Forest University
First posted: 2014-10-13
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 hamstring muscle function. Subjects will be adults age 18 and older with grade 2 or 3 hamstring injury who participate in greater than 100 hours per year in Level 1 or Level 2 athletics or have a similar activities or physical work load (e.g. military personnel). Subjects will undergo examination, MRI, and functional assessment before, during, and after 4 weeks of losartan (50mg QD) or placebo.


Eligibility criteria: 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. Sickle cell anemia/trait;
13. 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

Primary outcomes:
measure: Reported Effects of Losartan for Hamstring Injury for Safety and Tolerability
timeFrame: 4 weeks
measure: Recovery of Hamstring Muscle Function
timeFrame: 6 weeks; 6 months
measure: Recovery of Hamstring Structure
timeFrame: 6 months
measure: Recovery of Hamstring Structure
timeFrame: 6 months
measure: Return to Prior Level of Function
timeFrame: 12 months
measure: Recurrence of Injury
timeFrame: 12 months
Secondary outcomes:
measure: Recovery of Hamstring Structure
timeFrame: 6 months
measure: Return to Prior Level of Function
timeFrame: 4 Weeks, 6 Weeks, 3 Months, 4 Months, 6 Months, 12 Months
measure: Recovery of Hamstring Flexibility
timeFrame: 6 weeks; 6 months
measure: Recovery of Hamstring Muscle Function
timeFrame: 1 week; 2 weeks; 3 week; 4 weeks
measure: Recovery of Hamstring Muscle Function
timeFrame: 6 weeks, 6 months
measure: Recovery of Hamstring Muscle Function
timeFrame: 6 weeks, 6 months
measure: Recovery of Hamstring Muscle Function
timeFrame: 6 weeks, 6 months
measure: Recovery of Hamstring Muscle Function
timeFrame: 6 weeks, 6 months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: James J Irrgang, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: