Losartan for Arthrofibrosis

Overseen By Daniel Waren

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: NYU Langone Health

Must be taking: Losartan

Must not be taking: ACE-inhibitors, Angiotensin blockers

Disqualifiers: Revision surgery, Fracture, Infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Trial Summary

What is the purpose of this trial?

This trial is testing if Losartan, a blood pressure medication, can help reduce scar tissue and stiffness in patients after knee replacement surgery. It aims to improve movement and reduce the need for additional surgeries. Losartan has been studied for various effects including reducing blood pressure and improving heart function.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are already taking an ACE-inhibitor or Angiotensin receptor blocker for hypertension, you cannot participate in this study.

Is losartan generally safe for humans?

Losartan, also known as Cozaar or Hyzaar, is generally well tolerated in humans and has been used safely for conditions like high blood pressure and heart failure. It has a low incidence of side effects, with some studies showing it is better tolerated than other similar medications. ^{1 2 3 4 5}

How is the drug Losartan unique for treating arthrofibrosis?

Losartan is unique for treating arthrofibrosis because it is primarily known as a medication for high blood pressure and heart-related conditions, and its use for arthrofibrosis is novel, as there are no standard treatments specifically for this condition. ^{6 7 8 9 10}

Research Team

Joshua Rozell, MD

Principal Investigator

NYU Langone Health

Eligibility Criteria

Inclusion Criteria

Patients have been medically cleared and scheduled for surgery

Patients ≥18 years of age

Patients' primary care physician has verified that the patient can safely take the described dose of Losartan for the duration of the study period.

Exclusion Criteria

Bilateral, simultaneous surgery

You recently had surgery for a broken bone, infection, or cancer.

You are currently taking medication for high blood pressure called ACE-inhibitor or Angiotensin receptor blocker.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative Treatment

Participants receive losartan pre-operatively to evaluate its efficacy on range of motion and incidence of manipulation under anesthesia

2 weeks

Post-operative Treatment

Participants continue to receive losartan post-operatively to assess its impact on range of motion and manipulation under anesthesia

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, focusing on range of motion and manipulation under anesthesia

90 days

Treatment Details

Interventions

• Losartan

Participant Groups

Group I: Losartan Group Experimental Treatment 1 Intervention

Group II: Control Group Active Control 1 Intervention

No additional steps in management are required for the control arm of the study.

Losartan is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Cozaar for:

• Hypertension
• Diabetic nephropathy
• Stroke prevention in hypertension and left ventricular hypertrophy

Approved in European Union as Cozaar for:

• Hypertension
• Diabetic nephropathy
• Heart failure

Approved in Canada as Cozaar for:

• Hypertension
• Diabetic nephropathy
• Heart failure

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Findings from Research

Losartan, a medication for hypertension, was well-tolerated in approximately 2000 patients, showing a lower incidence of adverse effects compared to other antihypertensive drugs, particularly ACE inhibitors.

The most common side effects reported with losartan were headache and dizziness, but overall, it had a better safety profile with only 2.3% of patients withdrawing due to adverse effects, and no significant safety concerns were noted across different demographic groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and tolerability of losartan compared with atenolol, felodipine and angiotensin converting enzyme inhibitors. Goldberg, AI., Dunlay, MC., Sweet, CS.[2019]

Losartan/hydrochlorothiazide (HCTZ) is an effective fixed-dose combination therapy for hypertension, providing greater blood pressure reduction than either medication alone, and is particularly beneficial for patients with severe hypertension and left ventricular hypertrophy (LVH).

In the LIFE study, losartan-based therapy demonstrated a lower incidence of cardiovascular events and new-onset diabetes compared to atenolol, highlighting its safety and efficacy in reducing stroke risk and improving overall cardiovascular health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Losartan/Hydrochlorothiazide: a review of its use in the treatment of hypertension and for stroke risk reduction in patients with hypertension and left ventricular hypertrophy. Keating, GM.[2021]

Losartan potassium, an angiotensin II receptor antagonist, shows significant haemodynamic benefits in patients with heart failure, based on extensive clinical trials.

The drug is well tolerated with a low incidence of adverse effects related to kidney function, making it a safe option for treating hypertension and heart failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Losartan in heart failure: preclinical experiences and initial clinical outcomes. Sweet, CS., Rucinska, EJ.[2019]

References

1. Germany pubmed.ncbi.nlm.nih.gov

The effect of losartan on range of motion and rates of manipulation in total knee arthroplasty: a retrospective matched cohort study. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Safety and tolerability of losartan compared with atenolol, felodipine and angiotensin converting enzyme inhibitors. [2019]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Losartan/Hydrochlorothiazide: a review of its use in the treatment of hypertension and for stroke risk reduction in patients with hypertension and left ventricular hypertrophy. [2021]

4. France pubmed.ncbi.nlm.nih.gov

The effect of losartan on the development of post-traumatic joint stiffness in a rat model. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Losartan in heart failure: preclinical experiences and initial clinical outcomes. [2019]

6. France pubmed.ncbi.nlm.nih.gov

[Disease-modifying treatment for inflammatory rheumatism in sub-Saharan Africa: outcome at 6 months of 205 Senegalese patients with rheumatoid arthritis]. [2016]

7. Spain pubmed.ncbi.nlm.nih.gov

[Adherence to biological therapies in patients with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. (Study ADhER-1)]. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Predictive validity of the 5-item Compliance Questionnaire for Rheumatology (CQR5) in detecting poor adherence of patients with rheumatoid arthritis to biological medication. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Very recent onset rheumatoid arthritis: clinical and serological patient characteristics associated with radiographic progression over the first years of disease. [2022]

10. Italy pubmed.ncbi.nlm.nih.gov

Discontinuation of disease-modifying anti-rheumatic drugs and clinical outcomes in the Rheumatoid Arthritis DMARD Intervention and Utilisation Study 2 (RADIUS 2). [2017]