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

August 22, 2007
August 22, 2007
January 2005
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No Changes Posted
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Losartan Therapy in Pulmonary Hypertension
Losartan Decreases Pulmonary Artery Pressure and Improves Exercise Capacity in Patients With Pulmonary Hypertension

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.

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Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Pulmonary Hypertension
  • 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
Active Comparator: I, II
I: nifedipine II: losartan
Interventions:
  • Drug: nifedipine, losartan
  • Drug: losartan
  • Drug: Nifedipine, losartan
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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July 2005
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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
Both
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No
Contact information is only displayed when the study is recruiting subjects
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NCT00519870
KA04/127
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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
Baskent University
August 2007

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