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Losartan Therapy in Pulmonary Hypertension

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00519870
First Posted: August 23, 2007
Last Update Posted: August 23, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Baskent University
  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 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Baskent University:

Study Start Date: January 2005
Estimated Study Completion Date: July 2005
Arms Assigned Interventions
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 Name: losartan (Cozaar, Merck Sharp & Dohme, Wilmington, DE, USA) 50 mg/d
Drug: Nifedipine, losartan
I: nifedipine II: losartan

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00519870     History of Changes
Other Study ID Numbers: KA04/127
First Submitted: August 22, 2007
First Posted: August 23, 2007
Last Update Posted: August 23, 2007
Last Verified: August 2007

Keywords provided by Baskent University:
Pulmonary hypertension
Angiotensin receptor blocker
Calcium channel blocker

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Losartan
Nifedipine
Anti-Arrhythmia Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Calcium Channel Blockers
Membrane Transport Modulators
Vasodilator Agents
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs