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
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
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
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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