Losartan Therapy in Pulmonary Hypertension

Baskent University

Status and phase: Completed; Phase 3

Conditions: Pulmonary Hypertension

Treatments: Drug: losartan; Drug: nifedipine, losartan; Drug: Nifedipine, losartan

Study type: Interventional

Funder types: Other

Identifiers

NCT00519870

KA04/127

Details and patient eligibility

About

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.

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 1 patient group

I, II

Active Comparator group

Description:

I: nifedipine II: losartan

Treatment:

Drug: nifedipine, losartan

Drug: losartan