NCT04715568Toboroz4. fázis
Secondhand Tobacco Smoke and Cardiovascular Disease
Occult Cardiovascular Disease With Chronic Exposure to Secondhand Tobacco Smoke
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. aug. 19.
Rövid összefoglaló (regiszter, angolul)
This is a double-blind randomized placebo-controlled crossover clinical trial of efficacy and safety of an FDA-approved angiotensin receptor blocker (losartan) to improve cardiopulmonary outcomes in individuals with pre-Chronic Obstructive Pulmonary Disease (COPD) due to prolonged exposure to secondhand tobacco smoke.
- Állapot (regiszter)
- Toboroz
- Fázis (regiszter)
- 4. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 100 (tervezett)
- Első benyújtás
- 2020. dec. 17.
- Kezdés
- 2021. márc. 30.
- Elsődleges befejezés
- 2026. dec. 31.
- Fő szponzor
- University of California, San Francisco
- Betegségek
- Magas vérnyomás
- NCT-szám
- NCT04715568
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 4. fázis
- Tervezett résztvevők: 100
- 2021. márc. 30. és az elsődleges befejezés (2026. dec. 31.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
Ki nem vehet részt
Szó szerint a(z) ClinicalTrials.gov forrásból, témák szerint csoportosítva. Hogy ki vehet részt, azt csak a vizsgálat csapata dönti el.
Korábbi kezelés
- Current therapy with angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB).
- Known intolerance to ACE inhibitor or ARB.
- Significant history of recreational drug use other than marijuana as defined by: recreational drug use within the last 30 years of recruitment (or) recreational drug use at a frequency of more than once a month before 30 years.
- Concomitant participation in another interventional study.
Más betegség
- History of angioedema.
- Conventional indication for ACE inhibitor or ARB (e.g., history of myocardial infarction, known cardiomyopathy).
- History of clinically overt pulmonary disease that may interfere with study procedures, including: greater than mild asthma, COPD, emphysema, chronic interstitial lung disease, and pulmonary hypertension.
- Neuromuscular disorders or physical disability to perform exercise testing using an ergometer.
- Other uncontrolled chronic illnesses which in the judgment of the study physician would interfere with completing study procedures.
- Failure to keep screening appointments or other indicators of non-adherence.
Laborértékek
- Renal insufficiency (Creatinine Clearance \<30 mL/min by Cockcroft-Gault calculation).
- Potassium supplementation or serum potassium level of 5.0 milliequivalents (mEq)/dL or higher at V1.
- Current use of a potassium sparing diuretic.
- 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).
Egyéb
- Inability or unwillingness of a participant to give written informed consent or comply with study protocol.
- Subject is pregnant, breast-feeding, or plans to become pregnant.
- Blood pressure less than 90 mm Hg systolic or 60 mm Hg diastolic while standing or sitting.
- Known unilateral or bilateral renal artery stenosis higher than 70%.
- Current regular use of NSAIDs defined as daily use on 5 or more days of the week for more than one month.
- Marijuana use more than once a week.
- Subjects with BMI \<15 or \>40 kg/m2.
- MRI Scan Participation Exclusion Criteria - The participants will be excluded from the MRI portion of the study if they have a metallic object embedded or implanted in their body that is incompatible with Magnetic Resonance (MR) scanning, including MR incompatible pacemaker or defibrillator.
Kiket keres a vizsgálat
- Must be able to understand and provide informed consent.
- Adults \>= 40 years of age.
- 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 have never smoked or have a remote history of light smoking defined as follows:
- Lifetime smoking history equivalent to \< 1 pack-year and
- No smoking history for \>= 20 years at the time of enrollment.
Életkor a regiszterben: 40 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| San Francisco Veterans Affairs Medical Center Ennek a helyszínnek vagy a koordinátora? Erősítsd meg az állapotát | San Francisco | Egyesült Államok | Toboroz |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.