Losartan Therapy in Pulmonary Hypertension

Sponsor

Baskent University (Other)

Overall Status

Completed

CT.gov ID

NCT00519870

Collaborator

(none)

Arm

5.9

Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Hypertension	Drug: nifedipine, losartan Drug: losartan Drug: Nifedipine, losartan	Phase 3

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Losartan Decreases Pulmonary Artery Pressure and Improves Exercise Capacity in Patients With Pulmonary Hypertension

Study Start Date :

Jan 1, 2005

Study Completion Date :

Jul 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: I, II I: nifedipine II: losartan	Drug: nifedipine, losartan I: nifedipine 30 mg/d II: losartan 50 mg/d Other Names: nifedipine (Adalat Crono, Bayer AG, Leverkusen, Germany) losartan (Cozaar, Merck Sharp & Dohme, Wilmington, DE, USA) Drug: losartan II: losartan Other Names: losartan (Cozaar, Merck Sharp & Dohme, Wilmington, DE, USA) 50 mg/d Drug: Nifedipine, losartan I: nifedipine II: losartan

Arm

Intervention/Treatment

Active Comparator: I, II

I: nifedipine II: losartan

Drug: nifedipine, losartan

I: nifedipine 30 mg/d II: losartan 50 mg/d

Other Names:

nifedipine (Adalat Crono, Bayer AG, Leverkusen, Germany)

losartan (Cozaar, Merck Sharp & Dohme, Wilmington, DE, USA)

Drug: losartan

II: losartan

Other Names:

losartan (Cozaar, Merck Sharp & Dohme, Wilmington, DE, USA) 50 mg/d

Drug: Nifedipine, losartan

I: nifedipine II: losartan

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Baskent University

Investigators

Principal Investigator: Serife Savas Bozbas, MD, Baskent University Faculty of Medicine, Department of Pulmonary Disease
Study Chair: Fusun Oner Eyuboglu, MD, Baskent University Faculty of Medicine, Department of Pulmonary Disease