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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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

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
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

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

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

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
Calcium Channel Blockers
Nifedipine
Losartan
Angiotensin Receptor Antagonists
Membrane Transport Modulators
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs
Vasodilator Agents
Anti-Arrhythmia Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers

ClinicalTrials.gov processed this record on May 21, 2013