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Losartan Therapy in Pulmonary Hypertension

Primary Purpose

Pulmonary Hypertension

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
nifedipine, losartan
losartan
Nifedipine, losartan
Sponsored by
Baskent University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Hypertension focused on measuring Pulmonary hypertension, Angiotensin receptor blocker, Calcium channel blocker

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Active Comparator

    Arm Label

    I, II

    Arm Description

    I: nifedipine II: losartan

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    August 22, 2007
    Last Updated
    August 22, 2007
    Sponsor
    Baskent University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00519870
    Brief Title
    Losartan Therapy in Pulmonary Hypertension
    Official Title
    Losartan Decreases Pulmonary Artery Pressure and Improves Exercise Capacity in Patients With Pulmonary Hypertension
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2007
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2005 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    July 2005 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Baskent University

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pulmonary Hypertension
    Keywords
    Pulmonary hypertension, Angiotensin receptor blocker, Calcium channel blocker

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized

    8. Arms, Groups, and Interventions

    Arm Title
    I, II
    Arm Type
    Active Comparator
    Arm Description
    I: nifedipine II: losartan
    Intervention Type
    Drug
    Intervention Name(s)
    nifedipine, losartan
    Other Intervention Name(s)
    nifedipine (Adalat Crono, Bayer AG, Leverkusen, Germany), losartan (Cozaar, Merck Sharp & Dohme, Wilmington, DE, USA)
    Intervention Description
    I: nifedipine 30 mg/d II: losartan 50 mg/d
    Intervention Type
    Drug
    Intervention Name(s)
    losartan
    Other Intervention Name(s)
    losartan (Cozaar, Merck Sharp & Dohme, Wilmington, DE, USA) 50 mg/d
    Intervention Description
    II: losartan
    Intervention Type
    Drug
    Intervention Name(s)
    Nifedipine, losartan
    Intervention Description
    I: nifedipine II: losartan

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Serife Savas Bozbas, MD
    Organizational Affiliation
    Baskent University Faculty of Medicine, Department of Pulmonary Disease
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Fusun Oner Eyuboglu, MD
    Organizational Affiliation
    Baskent University Faculty of Medicine, Department of Pulmonary Disease
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    Losartan Therapy in Pulmonary Hypertension

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