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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
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
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Mean Peak Oxygen Consumption (VO2 Peak) Level
Change in Prevalence of CD14++CD16-
Mean Aortic pulse wave velocity (PWV)
+1 moreSecondary outcome measures
Change in Mean Angiotensin Converting Enzyme (ACE) Level
Change in Mean C-Reactive Protein (CRP) Level
Change in Mean Change in Borg Score
+12 moreSide effects data
From 2021 Phase 4 trial • 227 Patients • NCT0218812143%
Laboratory values outside normal range
23%
Psychiatric Hospitalization
6%
Medical Hospitalization
2%
Elevated creatine kinase level
1%
Muscle pain
1%
Hypotension
1%
Dehydration
1%
Leukemia
1%
Placed on Lithium while on Losartan
100%
80%
60%
40%
20%
0%
Study treatment Arm
Statin and/or Angiotensin Receptor Blocker
Usual Treatment
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
Find a Location
Who is running the clinical trial?
Flight Attendant Medical Research InstituteOTHER
12 Previous Clinical Trials
2,572 Total Patients Enrolled
University of California, San FranciscoLead Sponsor
2,505 Previous Clinical Trials
15,237,455 Total Patients Enrolled
Mehrdad Arjomandi, MDPrincipal InvestigatorUniversity of California, San Francisco
2 Previous Clinical Trials
147 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently taking medication that helps my body retain potassium.I have a heart condition that requires ACE inhibitor or ARB treatment.I have never smoked or was only a light smoker.My potassium levels are above 5.0 mEq/dL or I am on potassium supplements.You have used recreational drugs (other than marijuana) frequently within the last 30 years, or you have used recreational drugs more than once a month before turning 30 years old.I have not smoked for 20 years or more.I have smoked less than 1 pack of cigarettes a year in my life.I was exposed to secondhand smoke at work for at least 5 years.I am currently taking medication for my blood pressure.I have a history of serious heart problems.I have a condition or disability that prevents me from doing exercise tests.My kidneys are not working well (low creatinine clearance).I have a narrowing of one or both kidney arteries by more than 70%.I do not have any MR incompatible metal implants in my body.I am 40 years old or older.I do not have severe lung conditions that could affect the study.You have experienced negative reactions or side effects when taking ACE inhibitors or ARBs.I regularly use NSAIDs, almost daily, for over a month.You have a history of angioedema, a condition that causes swelling in certain areas of your body.You regularly use marijuana more than once a week.My BMI is either below 15 or above 40.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo then Losartan
- Group 2: Losartan then Placebo
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
High Blood Pressure Patient Testimony for trial: Trial Name: NCT04715568 — Phase 4
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the recruitment process for this study still open?
"Clinicaltrials.gov reports that this medical investigation is actively seeking participants, with the trial first uploaded on March 30th 2021 and amended as recently as April 29th 2022."
Answered by AI
What is the total number of participants in this trial?
"Affirmative. Clinicaltrials.gov's records show that this clinical trial, initially listed on March 30th 2021, is actively recruiting participants from a single location and requires 100 patients in total."
Answered by AI
Has the Food and Drug Administration approved Losartan for medical use?
"The existing data detailing Losartan's safety classifies it as a 3, considering that this is Phase 4 of the clinical trial process and therefore has been approved."
Answered by AI
What is the ultimate aim of this clinical research?
"This clinical trial will be conducted over a 1-day baseline period and aims to measure the Change in Mean Peak Oxygen Consumption (VO2) Level. Secondary outcomes that are being assessed include changes in maximum oxygen pulse, diastolic blood pressure slope, and systolic blood pressue slope."
Answered by AI
What ailments does Losartan commonly address?
"Losartan may be prescribed to those suffering from hypotension, as well as various other maladies including diabetic nephropathy, left ventricular hypertrophy, and proteinuria."
Answered by AI
Who else is applying?
What state do they live in?
California
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What site did they apply to?
San Francisco Veterans' Affairs Medical Center
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
I'm tired of using 3 inhalers to keep me from getting exacerbation or worse.
PatientReceived 2+ prior treatments
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