Losartan for Cardiovascular Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests losartan, a medication, to determine if it can help individuals exposed to significant secondhand tobacco smoke avoid developing chronic lung problems. The study compares losartan with a placebo (a harmless pill with no active drug) to measure effects on heart and lung health. Participants will alternate between the placebo and losartan, allowing researchers to compare results. This trial may suit non-smokers or those who smoked minimally in the past and have worked in smoky environments, such as certain flight attendants or casino workers. As a Phase 4 trial, losartan is already FDA-approved and proven effective; this research aims to understand how it benefits more patients.
Will I have to stop taking my current medications?
The trial requires that you do not currently use certain medications like ACE inhibitors, ARBs, NSAIDs regularly, or potassium supplements. If you are on these medications, you may need to stop them to participate.
What is the safety track record for losartan?
Research shows that losartan is generally safe for people. The FDA has approved this drug, which is commonly used to treat high blood pressure and protect the kidneys. Studies have found that most people tolerate losartan well.
In clinical trials, side effects were usually mild. Some individuals might experience dizziness or a stuffy nose, but these effects are not serious and often resolve over time. Serious side effects are rare. Losartan has been used safely in many studies, including those focused on heart and kidney health.
Overall, research supports the safety of losartan, but discussing any concerns with a doctor before starting a new treatment is always advisable.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about Losartan for cardiovascular disease because it targets the angiotensin II receptor, which helps relax blood vessels and lower blood pressure. Unlike many standard treatments that might focus on different pathways or involve complex combinations, Losartan's mechanism offers a direct approach to reducing strain on the heart. Additionally, its established safety profile from treating hypertension makes it a promising option for broader cardiovascular applications, potentially offering more tailored treatment strategies for patients.
What is the effectiveness track record for losartan in improving cardiopulmonary outcomes in individuals with pre-COPD?
Research has shown that losartan, an FDA-approved medication, can lower the risk of heart problems. In studies, losartan reduced heart-related issues by 25% compared to atenolol. It also alleviates symptoms like shortness of breath in people with heart failure. Losartan blocks certain signals that cause blood vessels to tighten, allowing them to relax and improve blood flow. In this trial, participants will receive either losartan or a placebo in different sequences to evaluate its effects. These benefits suggest that losartan might improve heart and lung function in people at risk of COPD from secondhand smoke exposure.46789
Who Is on the Research Team?
Mehrdad Arjomandi, MD
Principal Investigator
University of California, San Francisco
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either placebo or losartan for 4 weeks, followed by a 2-week washout period, then crossover to the alternate treatment for another 4 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Losartan
- Placebo
Losartan is already approved in United States, European Union, Canada for the following indications:
- Hypertension
- Diabetic nephropathy
- Stroke prevention in hypertension and left ventricular hypertrophy
- Hypertension
- Diabetic nephropathy
- Heart failure
- Hypertension
- Diabetic nephropathy
- Heart failure
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, San Francisco
Lead Sponsor
Flight Attendant Medical Research Institute
Collaborator