Losartan Effects on Emphysema Progression
- Interventional
- Recruiting
- NCT02696564
Contact Information
Losartan Effects on Emphysema Progression
A randomized, parallel, placebo controlled trial to evaluate the effect of 100mg/day losartan on the progression of emphysema as measured by quantitative HRCT compared to placebo .
Gender
All
Age Group
40 Years and up
Accepting Healthy Volunteers?
No
- Mild to severe COPD: Ratio of forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) less than or equal to 0.70, FEV1 20-80% of predicted
- Current or former smoker
- HRCT scan with 5-35% of voxels with density less than -950 Hounsfield Units (HU)
- Ability to understand and willingness to sign consent documents
Exclusion Criteria:
- Current therapy with angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB)
- Known intolerance to ACE inhibitor or ARB
- History of angioedema
- Conventional indication for ACE inhibitor or ARB (e.g., history of myocardial infarction, known cardiomyopathy)
- Renal insufficiency (GFR <30 mL/min by Cockcroft-Gault calculation)
- Current regular use of NSAIDs defined as daily use 5 or more days of the week for more than one month
- Potassium supplementation or serum potassium level of 5.0 milliequivalents (mEq)/dL or higher at V1
- Current use of a potassium sparing diuretic
- COPD exacerbation requiring treatment within 6 weeks at V1
- Chronic systemic corticosteroid use of more than 10mg/day of prednisone
- Resting SpO2 <89% on 2 L nasal cannula continuous flow; unless at altitude > 4,000 feet, then resting oxygen saturation (SpO2) <89% on 4 L N C continuous flow
- Untreated arterial hypertension (systolic blood pressure greater than140 mm Hg, diastolic blood pressure greater than 90 mm Hg)
- 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%
- Previous lung resection surgery
- Evidence of interstitial, occupational or chronic infectious lung disease
- Changes to chest that preclude adequate HRCT imaging (e.g. Metallic objects in the chest such as shrapnel or pacemaker leads)
- For women of child bearing potential, positive pregnancy test or unwillingness to use two methods of birth control or abstinence for the duration of the study
- Major chronic illnesses which in the judgment of the study physician would interfere with participation in the study e.g. including but not limited to: cardiac, renal, hepatic (LFTs more than 2.5x normal upper limit), neurological, psychiatric, endocrine or neoplastic diseases, uncontrolled diabetes, uncontrolled HIV infection or other immune system disorder, hyperthyroidism, seizure disorders, non-skin cancer, rheumatic diseases
- Failure to keep screening appointments or other indicators of non-adherence
- Inability to be contacted by telephone
- Intention to leave area within 12 months
- Emphysema