Losartan Therapy in Pulmonary Hypertension - Full Text View

Sponsor:	Baskent University
Information provided by:	Baskent University
ClinicalTrials.gov Identifier:	NCT00519870

Purpose

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	Intervention	Phase
Pulmonary Hypertension	Drug: nifedipine, losartan Drug: losartan Drug: Nifedipine, losartan	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Losartan Decreases Pulmonary Artery Pressure and Improves Exercise Capacity in Patients With Pulmonary Hypertension

Resource links provided by NLM:

MedlinePlus related topics: Calcium Exercise and Physical Fitness High Blood Pressure Pulmonary Hypertension

Drug Information available for: Nifedipine Losartan Losartan potassium

U.S. FDA Resources

Further study details as provided by Baskent University:

Study Start Date:	January 2005
Estimated Study Completion Date:	July 2005

Arms	Assigned Interventions
I, II: Active Comparator I: nifedipine II: losartan	Drug: nifedipine, losartan I: nifedipine 30 mg/d II: losartan 50 mg/d Drug: losartan II: losartan Drug: Nifedipine, losartan I: nifedipine II: losartan

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00519870

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

More Information

No publications provided

Study ID Numbers:	KA04/127
Study First Received:	August 22, 2007
Last Updated:	August 22, 2007
ClinicalTrials.gov Identifier:	NCT00519870 History of Changes
Health Authority:	Turkey: Ministry of Health

Keywords provided by Baskent University:

Pulmonary hypertension
Angiotensin receptor blocker
Calcium channel blocker

Additional relevant MeSH terms:

Vasodilator Agents
Losartan
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Vascular Diseases
Calcium Channel Blockers
Reproductive Control Agents
Cardiovascular Agents
Antihypertensive Agents
Nifedipine
Pharmacologic Actions

Angiotensin II Type 1 Receptor Blockers
Membrane Transport Modulators
Tocolytic Agents
Respiratory Tract Diseases
Hypertension, Pulmonary
Therapeutic Uses
Lung Diseases
Cardiovascular Diseases
Anti-Arrhythmia Agents
Hypertension

ClinicalTrials.gov processed this record on November 11, 2009