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

This study is currently recruiting participants.
Verified August 2017 by James J. Irrgang, University of Pittsburgh
Sponsor:
ClinicalTrials.gov Identifier:
NCT02263729
First Posted: October 13, 2014
Last Update Posted: August 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Brooke Army Medical Center
Wake Forest University
Information provided by (Responsible Party):
James J. Irrgang, University of Pittsburgh
  Purpose
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.

Condition Intervention Phase
Hamstring Injury Drug: Losartan Drug: placebo Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 1/2 Prospective Double-blind, Placebo-controlled Randomized Clinical Trial Using Losartan to Treat Grade II and III Hamstring Strains

Resource links provided by NLM:


Further study details as provided by James J. Irrgang, University of Pittsburgh:

Primary Outcome Measures:
  • Reported effects of losartan for hamstring injury for safety and tolerability [ Time Frame: 4 weeks ]
    Directly related to specific aim 1- Side effects, safety, and tolerability will be monitored by measuring vital signs, lab values via blood work, and number of adverse events, serious adverse events, and patient reported side effects.

  • Recovery of hamstring muscle function and structure [ Time Frame: 6 months ]
    Related to specific aim 2, hamstring muscle function of the injured leg will be measured and compared to the contralateral leg using isometric hamstring torque. Hamstring function is measured by comparing pre-treatment MRI to MRI at 6 months post-treatment

  • Return to prior level of function [ Time Frame: 12 months ]
    Return to prior level of function will be measured by the number of days from injury to full, unrestricted return to practice.

  • Recurrence of injury [ Time Frame: 12 months ]
    Number of recurrent injuries will be monitored during the duration of the subjects participation.


Estimated Enrollment: 10
Study Start Date: July 2016
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: losartan
Subjects will taken 50mg of losartan per day for 4 weeks
Drug: Losartan
Placebo Comparator: placebo
Subjects will be given placebo to replicate appearance of losartan pills. Placebo pill will be taken once per day.
Drug: placebo

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Between 18-35 years of age;
  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) activities;
  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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02263729


Contacts
Contact: James Irrgang, PT,PhD irrgangjj@upmc.edu

Locations
United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: James Irrgang, PT, PhD       irrgangjj@upmc.edu   
Principal Investigator: James Irrgang, PT, PhD         
Sponsors and Collaborators
University of Pittsburgh
Brooke Army Medical Center
Wake Forest University
  More Information

Responsible Party: James J. Irrgang, PT, PhD, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02263729     History of Changes
Other Study ID Numbers: PRO14050083
W81XWH-13-2-0052 ( Other Grant/Funding Number: Department of Defense )
First Submitted: September 26, 2014
First Posted: October 13, 2014
Last Update Posted: August 16, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Losartan
Anti-Arrhythmia Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action