Recruiting
Phase 2

Losartan

Sponsor:

Brigham and Women's Hospital

Code:

NCT06933706

Conditions

Multi-ligament Knee Injury

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Not accepted

Interventions

losartan 25 mg

Placebo capsule

Study Details

Brief summary:

Multi-ligament knee injuries (MLKIs) can occur during military training, sports injuries, or traumatic events such as motor vehicle accidents and can be devastating events. These complex injuries involving disruption of 2 or more ligaments often coincide with injuries to arteries, nerves, tendons, menisci, and/or fractures and can be devastating events. MLKIs often require complex treatments nearly 2 in 5 patients suffer complications after surgery. Loss of knee range of motion is the most common complication and is associated with military separation. There are also long-term effects of motion loss, as the need for motion-restoring surgery after MLKI is associated with an increased risk of osteoarthritis within 5 years of surgery. A person's ability to perform both activities of daily living and higher demand physical activities is often impaired both in the short and long term. In fact, only 1 in 3 people return to high-level sport after MLKI. The purpose of this translational randomized clinical trial is to determine if a 30-day course of oral Losartan improves a person's ability to return to work or sport, range of motion and strength, and reduce knee inflammation in the first year after surgical treatment of an MLKI.

Conditions

Multi-ligament Knee Injury

Study ID

NCT06933706

Start date

Oct 1, 2025

Status verified date

Jan, 2026

Completion date

Sep 30, 2029

Anticipated

Primary completion date

Sep 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Multi-ligament knee injury defined as a complete grade III injury of 2 or more ligaments
  • At least one ligament surgically reconstructed or repaired
  • Willingness to comply with the study protocol and assessments

Exclusion Criteria:

  • Allergic to any active or inactive ingredient of losartan
  • Pregnant, planning to become pregnant, or sexually active females choosing not to use effective means of contraception during the 30-day course of losartan
  • Those at increased risk of losartan related side effects including those with severe renal insufficiency, hepatic disease, hypotension, and/or hyperkalemia
  • Have a history of prior knee ligament surgery of the involved knee
  • Undergoing staged surgical procedures in the treatment of MLKI
  • Have a traumatic brain injury that limits their ability to participate in their postoperative care or any condition that would preclude the ability to comply with postoperative rehabilitation
  • Have a concomitant injury or underwent a surgical procedure that will preclude the ability to perform range of motion exercises (i.e. surgery for extensor mechanism rupture or avulsion, vascular graft surgery)

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Losartan

Participants randomized to the Losartan arm will be asked to take 25 mg of losartan per day for 30 days.

placebo comparator: Placebo

Participants randomized to the Placebo arm will be asked to take one placebo capsule per day for 30 days.

Interventions

losartan 25 mg

Losartan is an angiotensin-II inhibitor that modulates the renin-angiotensin system by blocking the activation of angiotensin type 1 receptors, thus preventing binding with angiotensin-II and decreasing blood pressure. Losartan has a broader therapeutic potential for muscle healing and treatment for diseases ranging from rheumatoid arthritis, osteoarthritis, chronic kidney disease, Marfan syndrome, and fatty liver. TGF-β plays an active role in fibrosis leading to the formation of adhesions and scar tissue. By limiting the formation of adhesions and scar tissue, losartan may reduce pain, myofibroblast activity, synovitis, fibrosis, and cartilage degeneration.

Placebo capsule

The placebo capsule will look identical to the active study drug, but will not have any active ingredient and will be filled with corn starch

Primary outcome measure

  • Cincinnati Occupational Rating Scale (CORS) [ Time Frame: Baseline, 1 month, 6 months, and 12 months ]

Central Contacts and Locations

Central contacts

Cale Jacobs, PhD

508-216-1145cjacobs@bwh.harvard.edu

Molly Zgoda

508-216-1145mzgoda@mgb.org

Locations

Mass General Brigham

Recruiting

Foxborough, Massachusetts, United States, 02035

Contacts

Cale Jacobs

508-216-1145cjacobs@bwh.harvard.edu

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Jan 20, 2026

Last verified

Jan, 2026

Keywords

  • knee dislocation
  • multi-ligament knee injury
  • losartan

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2026-01-20.