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Losartan Therapy in Pulmonary Hypertension

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. Identifier: NCT00519870
Recruitment Status : Completed
First Posted : August 23, 2007
Last Update Posted : August 23, 2007
Information provided by:
Baskent University

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

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Study Type : Interventional  (Clinical Trial)
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 : January 2005
Study Completion Date : July 2005

Resource links provided by the National Library of Medicine

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

Drug: Nifedipine, losartan
I: nifedipine II: losartan

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00519870

Sponsors and Collaborators
Baskent University
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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
Layout table for additonal information Identifier: NCT00519870    
Other Study ID Numbers: KA04/127
First Posted: August 23, 2007    Key Record Dates
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:
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Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
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
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Tocolytic Agents
Reproductive Control Agents