Phase 1/2 Prospective Double-Blind Placebo-Controlled Randomized Clinical Trial of Losartan to Treat Grade II & III Hamstring Strains

James J. Irrgang

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Hamstring Injury

Treatments: Drug: Placebo; Drug: Losartan

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT02263729

W81XWH-14-2-0003 (Other Grant/Funding Number)

STUDY19100320

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

8 participants in 2 patient groups, including a placebo group

Losartan

Active Comparator group

Description:

Subjects will taken 50mg of losartan per day for 4 weeks

Treatment:

Drug: Losartan

Placebo

Placebo Comparator group

Description:

Subjects will be given placebo to replicate appearance of losartan pills. Placebo pill will be taken once per day.

Treatment:

Drug: Placebo