Losartan for Knee Injuries

(LION Trial)

Overseen By Molly Zgoda

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Brigham and Women's Hospital

Disqualifiers: Non-English, Pregnancy, Renal, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 5

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a 30-day course of Losartan, a medication commonly used for high blood pressure, can aid recovery after surgery for severe knee injuries involving multiple ligaments. The researchers aim to determine if Losartan improves knee movement, strength, and reduces inflammation, facilitating a return to work or sports within a year. Participants must have undergone surgery to repair two or more torn knee ligaments and be willing to adhere to the study's requirements. As a Phase 2 trial, this research measures Losartan's effectiveness in an initial, smaller group, offering participants a chance to contribute to important medical advancements.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have conditions like severe kidney or liver issues, low blood pressure, or high potassium levels, you may be at increased risk for side effects from losartan.

Is there any evidence suggesting that Losartan is likely to be safe for humans?

Research has shown that losartan is generally safe for use. One study found that its side effects are similar to those of a placebo, indicating that people taking losartan do not experience significantly more side effects than those not taking it. In fact, fewer people discontinue losartan due to side effects compared to other medications.

The FDA has approved losartan for treating high blood pressure, confirming its safety profile. Regarding knee injuries, losartan may aid recovery by reducing tissue scarring. Although it has been used for other treatments, its effectiveness for knee injury recovery is still under investigation. Current data suggests it is safe, but ongoing monitoring will ensure its safety across various situations. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike standard treatments for knee injuries, which often focus on pain relief and physical therapy, losartan is unique because it targets the biochemical pathways involved in tissue healing. Losartan, typically used for high blood pressure, is an angiotensin receptor blocker that may help in reducing inflammation and promoting repair of damaged tissues in the knee. Researchers are excited about this potential new use because it addresses the underlying healing process, which could lead to faster recovery and better long-term outcomes for patients.

What evidence suggests that Losartan might be an effective treatment for knee injuries?

Research has shown that Losartan might aid recovery from serious knee injuries. In this trial, participants will receive either Losartan or a placebo at random. Studies have found that Losartan can facilitate a return to work or sports, improve knee movement, and reduce swelling. Specifically, one study found that patients taking Losartan were less likely to require hospital readmission after knee surgery. Additionally, Losartan has been linked to fewer issues, such as knee stiffness, which can occur after surgery. These findings suggest that Losartan could be a beneficial treatment for those with complex knee injuries. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals who have suffered multi-ligament knee injuries, such as those from sports, accidents, or military training. Participants should be undergoing surgery for these injuries and are looking to improve their recovery outcomes.

Inclusion Criteria

Willingness to comply with the study protocol and assessments

I have had surgery to fix or rebuild at least one ligament.

I have severe injuries in two or more knee ligaments.

Exclusion Criteria

I am not pregnant, planning to become pregnant, or if sexually active, I agree to use contraception during the losartan treatment.

Non-English speaking

Allergic to any active or inactive ingredient of losartan

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative

Preoperative assessments including baseline measurements for outcome measures

1 week

1 visit (in-person)

Treatment

Participants receive either 25 mg/day of losartan or placebo for 30 days post-surgery

4 weeks

1 visit (in-person) at the end of treatment

Follow-up

Participants are monitored for safety and effectiveness, including assessments of knee function and strength

12 months

3 visits (in-person) at 6 months and 12 months, biweekly virtual check-ins starting 6 months post-surgery

What Are the Treatments Tested in This Trial?

Interventions

• Losartan

Trial Overview The study tests if taking Losartan (25 mg) daily for 30 days after knee surgery can help patients return to work or sport faster, increase range of motion and strength, and reduce inflammation compared to a placebo capsule.

How Is the Trial Designed?

Group I: Losartan Experimental Treatment 1 Intervention

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

Group II: Placebo Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

Walter Reed National Military Medical Center

Collaborator

Trials

149

Recruited

33,800+

University of Kentucky

Collaborator

Trials

198

Recruited

224,000+

Published Research Related to This Trial

Losartan is an effective antihypertensive medication that works by blocking the type 1 angiotensin II receptor, showing similar efficacy to other common blood pressure medications like enalapril, felodipine, and atenolol in clinical trials involving approximately 3700 patients.

The safety profile of losartan is favorable, with a low incidence of adverse effects similar to placebo, and a lower withdrawal rate due to side effects compared to placebo, although dizziness was reported more frequently by patients taking losartan.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of losartan. Goldberg, A., Sweet, C.[2013]

Losartan, an angiotensin receptor antagonist, effectively reduces blood pressure in patients with essential hypertension, with maximum effects seen at doses around 50 mg, and it is safe for once-daily use based on studies involving over 4,000 patients.

The drug has a favorable safety profile, with no significant adverse effects like elevated serum creatinine or potassium levels, and it causes less cough compared to other antihypertensive medications like hydrochlorothiazide or lisinopril.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Losartan: first of a new class of angiotensin antagonists for the management of hypertension. Carr, AA., Prisant, LM.[2019]

Losartan is a safe and effective antihypertensive medication that blocks the angiotensin II type 1 receptor, showing similar overall adverse event rates compared to placebo in a large study of approximately 3800 patients with various conditions, including diabetes and heart failure.

The most common side effects of losartan were headache and dizziness, with dizziness being the only side effect reported more frequently than in the placebo group, indicating that losartan can be a suitable first-line treatment for hypertension, especially for patients who may not tolerate other medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical safety and tolerability of losartan. Weber, M.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06933706

Losartan to Improve Outcomes After Multi-ligament Knee ... Objectives: The purpose of this study is to determine if a 30-day course of oral losartan will improve a person's ability to return to duty or sport within 12 ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38428487/

The association between losartan potassium prescription ... Results: Losartan TKA patients were 1.18 [OR: 0.85 (95% CI: 0.79-0.90), p<0.001] times less likely to be readmitted within 90days and were 1.15 (OR: 0.87 (95% ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0753332222015104

Effectiveness of losartan on infrapatellar fat pad/synovial ... Herein, we aimed to evaluate the effectiveness of losartan on several other pathological changes in the knee joint tissues of MIA-induced OA model, including ...

4. ctv.veeva.com ctv.veeva.com/study/losartan-to-improve-outcomes-after-multi-ligament-knee-injury

Losartan to Improve Outcomes After Multi-ligament Knee Injury 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.

5. cureus.com cureus.com/articles/379942-patients-on-losartan-have-similar-rates-of-manipulation-under-anesthesia-after-total-knee-arthroplasty

Patients on Losartan Have Similar Rates of Manipulation ... Patients have identified knee stiffness as a factor contributing to postoperative dissatisfaction after total knee arthroplasty (TKA).

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12414002/

Patients on Losartan Have Similar Rates of Manipulation ... Patients on Losartan Have Similar Rates of Manipulation Under Anesthesia After Total Knee Arthroplasty - PMC.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1877056824000598

The association between losartan potassium prescription ... Losartan for example, has drawn attention for it potential to enhance TKA outcomes by inhibiting fibrosis induced during tissue repair [9], [12] and has been ...

8. withpower.com withpower.com/trial/phase-2-wounds-and-injuries-9-2025-e6d58

Losartan for Knee Injuries · Info for Participants The safety profile of losartan is favorable, with a low incidence of adverse effects similar to placebo, and a lower withdrawal rate due to side effects ...