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Angiotensin Receptor Blocker

Losartan for Cardiovascular Disease

Phase 4

Recruiting

Led By Mehrdad Arjomandi, MD

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

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

Must have

No smoking history for >= 20 years at the time of enrollment

Must have a history of occupational exposure to secondhand tobacco smoke for at least 5 years such as flight attendants who worked for airlines before the smoking ban on aircrafts went into effect or casino workers who worked at casinos with no smoke-free policies

Must not have

History of clinically overt cardiovascular disease including: stable or unstable angina; chest discomfort and dyspnea with baseline exertion; symptomatic coronary artery disease (as defined by history of abnormal stress test; cardiac catheterization showing >70% coronary artery stenosis; history of revascularization; pathologic Q waves on EKG); poorly controlled resting hypertension (SBP>160/ DBP>95); congestive heart failure (CHF) (as defined by left ventricular ejection fraction (LVEF) <55%; physical exam findings of CHF; symptomatic pulmonary edema); significant (>mild) valvular heart disease; congenital heart disease; cardiac arrhythmias including frequent premature atrial or ventricular contractions (>5 per minute)

Current use of a potassium sparing diuretic

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at baseline assessment (v1); 4th week of v2 (placebo/losartan) treatment period; and 4th week of v3 (placebo/losartan) treatment period

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

Summary

This trial will test if losartan can improve cardiopulmonary outcomes in people with pre-COPD caused by long-term exposure to secondhand tobacco smoke. The trial is double-blind, meaning neither the participants nor the researchers will know who is taking losartan or the placebo until the trial is over.

Who is the study for?

Adults over 40 with a history of secondhand tobacco smoke exposure for at least 5 years, like former flight attendants or casino workers. They should have smoked less than one pack-year and not smoked for the past 20 years. Participants must be able to consent and follow the study plan but can't join if they're pregnant, breastfeeding, planning pregnancy, have certain heart conditions or blood pressure issues, drug use history (except occasional marijuana), are on specific medications like ACE inhibitors or ARBs, or have severe kidney problems.

What is being tested?

The trial is testing Losartan's effectiveness in improving heart and lung health against a placebo in people who've been exposed to secondhand smoke but don't yet have COPD. It's a double-blind study where neither participants nor researchers know who gets the real medicine versus the placebo until after results are collected.

What are the potential side effects?

Losartan may cause dizziness due to low blood pressure, increased potassium levels which can affect heart rhythm, mild swelling under the skin especially around eyelids (angioedema), and possible kidney function changes. The side effects often vary from person to person.

Eligibility Criteria

Inclusion Criteria

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

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I have not smoked for 20 years or more.

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I was exposed to secondhand smoke at work for at least 5 years.

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I have smoked less than 1 pack of cigarettes a year in my life.

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I am 40 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of serious heart problems.

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I am currently taking medication that helps my body retain potassium.

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I have a heart condition that requires ACE inhibitor or ARB treatment.

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My potassium levels are above 5.0 mEq/dL or I am on potassium supplements.

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I am currently taking medication for my blood pressure.

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I have a condition or disability that prevents me from doing exercise tests.

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My kidneys are not working well (low creatinine clearance).

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I have a narrowing of one or both kidney arteries by more than 70%.

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I do not have any MR incompatible metal implants in my body.

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I do not have severe lung conditions that could affect the study.

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I regularly use NSAIDs, almost daily, for over a month.

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My BMI is either below 15 or above 40.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at baseline assessment (v1); 4th week of v2 (placebo/losartan) treatment period; and 4th week of v3 (placebo/losartan) treatment period

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at baseline assessment (v1); 4th week of v2 (placebo/losartan) treatment period; and 4th week of v3 (placebo/losartan) treatment period

This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline assessment (v1); 4th week of v2 (placebo/losartan) treatment period; and 4th week of v3 (placebo/losartan) treatment period for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Mean Peak Oxygen Consumption (VO2 Peak) Level

Change in Prevalence of CD14++CD16-

Mean Aortic pulse wave velocity (PWV)

+1 more

Secondary study objectives

Change in Mean Angiotensin Converting Enzyme (ACE) Level

Change in Mean C-Reactive Protein (CRP) Level

Change in Mean Change in Borg Score

+12 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

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Placebo then LosartanExperimental Treatment2 Interventions

Placebo tablets will be administered for the first 4 weeks followed by a washout period of 2 weeks. After the washout period has been completed, losartan tablets will be administered for the next 4 weeks.

Group II: Losartan then PlaceboExperimental Treatment2 Interventions

Losartan tablets will be administered for the first 4 weeks followed by a washout period of 2 weeks. After the washout period has been completed, placebo tablets will be administered for the next 4 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

Losartan

2003

Completed Phase 4

~3000