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Losartan Therapy in Pulmonary Hypertension

NCT ID: NCT00519870

Last Updated: 2007-08-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2005-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pulmonary Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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I, II

I: nifedipine II: losartan

Group Type ACTIVE_COMPARATOR

nifedipine, losartan

Intervention Type DRUG

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

losartan

Intervention Type DRUG

II: losartan

Nifedipine, losartan

Intervention Type DRUG

I: nifedipine II: losartan

Interventions

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nifedipine, losartan

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

Intervention Type DRUG

losartan

II: losartan

Intervention Type DRUG

Nifedipine, losartan

I: nifedipine II: losartan

Intervention Type DRUG

Other Intervention Names

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nifedipine (Adalat Crono, Bayer AG, Leverkusen, Germany) losartan (Cozaar, Merck Sharp & Dohme, Wilmington, DE, USA) losartan (Cozaar, Merck Sharp & Dohme, Wilmington, DE, USA) 50 mg/d

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Baskent University

OTHER

Sponsor Role lead

Principal Investigators

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Serife Savas Bozbas, MD

Role: PRINCIPAL_INVESTIGATOR

Baskent University Faculty of Medicine, Department of Pulmonary Disease

Fusun Oner Eyuboglu, MD

Role: STUDY_CHAIR

Baskent University Faculty of Medicine, Department of Pulmonary Disease

Other Identifiers

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KA04/127

Identifier Type: -

Identifier Source: org_study_id