Losartan for Scarring After ACL Surgery

Overseen By Jorge Chahla, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Rush University Medical Center

Must not be taking: Diuretics, Lithium, Spironolactone, ARB/ACE-I

Disqualifiers: Hypotensive disease, Hepatic disease, Kidney disease, Rheumatologic disorders, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether losartan, a drug typically used to lower blood pressure, can reduce abnormal scar tissue formation after ACL knee surgery. The goal is to prevent arthrofibrosis, which involves excessive scar tissue that can limit knee movement and cause pain. Participants will take either losartan or a placebo (a non-active pill) to determine if losartan makes a difference. The trial seeks individuals undergoing ACL repair, possibly with minor related procedures. Those diagnosed with an ACL tear and planning surgery may find this trial suitable. As a Phase 4 trial, the research focuses on understanding how an already FDA-approved and effective treatment can benefit more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently taking diuretics, lithium, spironolactone, or certain blood pressure medications like ARBs or ACE inhibitors.

What is the safety track record for losartan?

Research has shown that losartan is generally safe and is often used to treat high blood pressure. Studies indicate that people taking low doses of losartan face minimal risks, with most not experiencing major side effects. Researchers are studying losartan for its potential to reduce scarring, which is why it is being tested for aiding recovery after surgeries like ACL repairs. The study has reached a stage where the treatment is usually considered safe, allowing researchers to focus on its effectiveness. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Losartan is unique because it targets the scarring process after ACL surgery, which is not typically addressed by current treatments like physical therapy and anti-inflammatory medications. Unlike these standard options, which focus on managing pain and improving mobility, losartan works on a molecular level by blocking certain receptors involved in tissue scarring. Researchers are excited about this treatment because it could potentially reduce scar tissue formation, leading to better long-term knee function and recovery outcomes.

What evidence suggests that losartan might be an effective treatment for scarring after ACL surgery?

Research has shown that losartan, a drug often used to lower blood pressure, might help reduce scar tissue after surgery by blocking certain chemicals in the body that lead to scar formation. Some studies suggest that losartan could reduce scar tissue in knee surgeries. However, other research found no major improvement in joint movement or the need for additional surgery with losartan. In this trial, participants will receive either losartan or a placebo to evaluate its effectiveness in reducing scar tissue after ACL surgery. While losartan effectively manages blood pressure, its ability to reduce scar tissue after surgery remains under study. ^{1 2 3 6 7}

Who Is on the Research Team?

Jorge Chahla, MD, PhD

Principal Investigator

Rush University Medical Center

Andrew Bi, MD

Principal Investigator

Rush University Medical Center

Are You a Good Fit for This Trial?

This trial is for individuals undergoing ACL reconstruction surgery who are interested in potentially reducing postoperative scarring. Specific eligibility criteria details were not provided, so participants should inquire about inclusion and exclusion factors.

Inclusion Criteria

I am having ACL surgery and may have additional minor knee procedures.

My knee bones have finished growing.

I am 18 years old or older.

Exclusion Criteria

I have never been diagnosed with an ACL tear.

I have chronic kidney disease.

I have had a bone infection in my leg before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 25mg losartan daily for 3 days followed by 50 mg losartan daily for 25 days

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Losartan

Trial Overview The study is testing the effectiveness of Losartan, a medication typically used to lower blood pressure that may also help prevent abnormal scar tissue after ACL repair surgery. Participants will be randomly assigned to receive either Losartan or a placebo.

How Is the Trial Designed?

Group I: Losartan Experimental Treatment 1 Intervention

The experimental arm (Arm 1) will receive 25mg losartan daily for 3 days followed by 50 mg losartan daily for 25 days.

Group II: Placebo Placebo Group 1 Intervention

The placebo arm (Arm 2) will receive a placebo tablet with the same appearance and frequency to that of the losartan group.

Who Is Running the Clinical Trial?

Rush University Medical Center

Lead Sponsor

Trials

448

Recruited

247,000+

Arthroscopy Association of North America (AANA)

Collaborator

Trials

1

Recruited

130+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07135687

Study to Use Oral Losartan to Decrease the Risk of ... The purpose of this study to investigate the effect of using losartan (a blood pressure lowering drug with anti-scarring properties) on preventing primary ...

2. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/87/NCT07135687/Prot_SAP_000.pdf

TITLE: Oral Losartan to Decrease the Risk of Postoperative ... The purpose of this study to investigate the effect of using losartan (a blood pressure lowering drug with anti-scarring properties) on ...

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

The association between losartan potassium prescription ... Losartan, an angiotensin receptor blocker (ARB), has the potential to improve TKA outcomes by inhibiting TGF-β and decreasing fibrosis.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36436067/

The effect of losartan on range of motion and rates ... In this study, we found that the use of Losartan did not significantly improve postoperative ROM, reduce MUA or decrease revision rates.

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 ... Outcomes data can be seen in Table 4. Variables, No Losartan, Losartan, p value. N = 6024, N = 2008. Length of Stay (Days), 1.28 {1.2-1.3}, 1.34 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11558279/

Angiotensin II receptor blockers and their applications in ... Importantly, the proposed dosing of losartan to prevent postoperative adhesions is 12.5 mg twice daily for 6 weeks following surgery, which is ...

7. aoj.amegroups.org aoj.amegroups.org/article/view/8828/html

Angiotensin II receptor blockers and their applications in ... Importantly, the proposed dosing of losartan to prevent postoperative adhesions is 12.5 mg twice daily for 6 weeks following surgery, which is a substantially ...