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Angiotensin II Receptor Blocker

Losartan for Total Knee Replacement Complications

Phase 1 & 2

Recruiting

Led By Johnny Huard, PhD

Research Sponsored by Steadman Philippon Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Capacity to personally give informed consent (consent via legally authorized representative will not be accepted) and who are willing to comply with all study-related procedures and assessments

Male or female ≥ 18 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 6 weeks post-op, and 3 months post-op

Awards & highlights

Study Summary

This trial evaluates if taking Losartan before/after surgery can help reduce complications and improve outcomes.

Who is the study for?

This trial is for adults over 18 who are planning to have a knee replacement surgery on one knee and can consent to the study. They should not be hypotensive, pregnant, or planning pregnancy; nor should they have had previous knee replacements or surgeries planned during the study. They must not take opioids recently or certain medications like Losartan.Check my eligibility

What is being tested?

The trial is testing if taking Losartan before and after knee replacement surgery can prevent arthrofibrosis (stiffness) and improve outcomes. Participants will either receive Losartan or a placebo without knowing which one they're getting.See study design

What are the potential side effects?

Losartan may cause side effects such as dizziness due to low blood pressure, fatigue, light-headedness especially upon standing up quickly, swelling in legs or arms, stuffy nose, back pain, and chest pain.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can make my own medical decisions and agree to follow the study's requirements.

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I am 18 years old or older.

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I am scheduled for a total knee replacement on one knee.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 6 weeks post-op, and 3 months post-op

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 6 weeks post-op, and 3 months post-op

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 weeks post-op, and 3 months post-op for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Knee Range of Motion

Quantitative Ultrasound Measurement of Capsular Thickness at Lateral Retinaculum

Secondary outcome measures

Flow cytometry immunosenescent phenotyping assessment of peripheral blood mononuclear cells

Incidence of Treatment-Emergent Adverse Events

Knee Extensor Isometric Strength Assessment

+4 more

Side effects data

From 2021 Phase 4 trial • 227 Patients • NCT02188121

43%

Laboratory values outside normal range

23%

Psychiatric Hospitalization

Medical Hospitalization

Elevated creatine kinase level

Muscle pain

Hypotension

Dehydration

Leukemia

Placed on Lithium while on Losartan

100%

80%

60%

40%

20%

Study treatment Arm

Statin and/or Angiotensin Receptor Blocker

Usual Treatment

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Losartan (investigational)Experimental Treatment1 Intervention

Losartan 12.5 mg, PO, BID, for four weeks post-TKA surgery (on Days 1 through 28, starting the day after surgery).

Group II: Placebo (control)Placebo Group1 Intervention

Losartan Placebo 12.5 mg, PO, BID, for four weeks post-TKA surgery (on Days 1 through 28, starting the day after surgery).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Losartan

2003

Completed Phase 4

~3000

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Steadman Philippon Research InstituteLead Sponsor

9 Previous Clinical Trials

495 Total Patients Enrolled

Johnny Huard, PhDPrincipal InvestigatorSteadman Philippon Research Institute

1 Previous Clinical Trials

100 Total Patients Enrolled

Scott Tashman, PhDPrincipal InvestigatorSteadman Philippon Research Institute

1 Previous Clinical Trials

57 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is recruitment of participants for this clinical trial currently underway?

"Based on the information present at clinicaltrials.gov, this medical study is no longer accepting candidates for participation. The experiment was originally posted in November of 2023 and last updated on October 26th, however there remain 37 other trials actively looking for enrollees currently."

Answered by AI

What is the goal of this experiment?

"This clinical trial will evaluate Knee Range of Motion over a Baseline, 6 weeks post-op, and 3 months post-op timeline. Secondary measurements include quantifying inflammation, fibrosis and senescence proteins in serum or plasma with commercially available immunocapture assays via TGF-ß multiplex immunoassay; flow cytometry for cell type identification and immune phenotype analysis as well as senescence panels; and knee extensor isometric strength assessment captured by a handheld dynamometer containing a load cell to digitally record the force applied during extension."

Answered by AI