Losartan Therapy in Pulmonary Hypertension

This study has been completed.

Sponsor:

Information provided by:

Baskent University

ClinicalTrials.gov Identifier:

NCT00519870

First received: August 22, 2007

Last updated: NA

Last verified: August 2007

History: No changes posted

Tracking Information

First Received Date ^ICMJE

August 22, 2007

Last Updated Date

August 22, 2007

Start Date ^ICMJE

January 2005

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Losartan Therapy in Pulmonary Hypertension

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Pulmonary Hypertension

Intervention ^ICMJE

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 Name: losartan (Cozaar, Merck Sharp & Dohme, Wilmington, DE, USA) 50 mg/d
Drug: Nifedipine, losartan
I: nifedipine II: losartan

Study Arm (s)

Active Comparator: I, II

I: nifedipine II: losartan

Interventions:

Drug: nifedipine, losartan
Drug: losartan
Drug: Nifedipine, losartan

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Not Provided

Completion Date

July 2005

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Both

Ages

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00519870

Other Study ID Numbers ^ICMJE

KA04/127

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Baskent University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

Baskent University

Verification Date

August 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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