Official Title: “Losartan Decreases Pulmonary Artery Pressure and Improves Exercise Capacity in Patients With Pulmonary Hypertension”

In addition to being effective vasodilators, angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) exert neurohumoral inhibitory actions, such as the inhibition of vascular remodeling and smooth muscle cell proliferation and the amelioration of endothelial dysfunction.

These beneficial effects, render those agents appropriate for use in the treatment of pulmonary hypertension. However, data regarding the use of ACEIs or ARBs in the treatment of PHT are limited. In this study, efficacy of an ARB, losartan was compared with those of the calcium channel blocker, nifedipine in the treatment of pulmonary hypertension using echocardiographic, 6-minute walk test (6MWT), cardiopulmonary exercise test, and endothelin-1 levels.Losartan is as effective as nifedipine for reducing Doppler echocardiographically measured PAP and improving exercise capacity on 6MWT and CPET.

However the short-term use of losartan or nifedipine had no statistically significant effect on endothelin-1 levels in patients with PHT.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: nifedipine, losartan
  • I: nifedipine 30 mg/d II: losartan 50 mg/d
• Drug: losartan
  • II: losartan
• Drug: Nifedipine, losartan
  • I: nifedipine II: losartan

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: I, II
  • I: nifedipine II: losartan

Inclusion Criteria:

• Pulmonary hypertension diagnosed by Doppler echocardiographic examination (a mean pulmonary artery pressure of > 26mmHg)

Exclusion Criteria:

• acute infectious or inflammatory disease,
• exacerbation of chronic obstructive pulmonary disease,
• malignancy,
• acute coronary syndrome in the last 4 weeks,
• uncontrolled arrhythmia and hypertension,
• decompensated heart failure,
• acute pulmonary emboli,
• thrombus in a lower extremity,
• oxygen saturation below 85% at rest,
• failure to cooperate with CPET

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Baskent University

Overall Clinical Trial Officials and Contacts

Serife Savas Bozbas, MD Principal Investigator Baskent University Faculty of Medicine, Department of Pulmonary Disease  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00519870

Study ID Number: KA04/127

ClinicalTrials.gov Identifier: NCT00519870

Health Authority: Turkey: Ministry of Health