Losartan Therapy in Pulmonary Hypertension

NCT00519870 | Completed Phase 3

• 1 other identifier: KA04/127
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pulmonary Hypertension

Keywords

Pulmonary hypertension; Angiotensin receptor blocker; Calcium channel blocker

Study Arms (1)

I, II

ACTIVE COMPARATOR

I: nifedipine II: losartan

Drug: nifedipine, losartan; Drug: losartan

Interventions

Nifedipine, losartan DRUG

I: nifedipine 30 mg/d II: losartan 50 mg/d

Also known as: nifedipine (Adalat Crono, Bayer AG, Leverkusen, Germany), losartan (Cozaar, Merck Sharp & Dohme, Wilmington, DE, USA)

I, II

losartan DRUG

II: losartan

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

I, II

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Pulmonary hypertension diagnosed by Doppler echocardiographic examination (a mean pulmonary artery pressure of \> 26mmHg)

You may not qualify if:

• 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

Sponsors & Collaborators

• Baskent University: lead

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

Nifedipine; Losartan

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Tetrazoles

Study Officials

• Serife Savas Bozbas, MD

  Baskent University Faculty of Medicine, Department of Pulmonary Disease

  PRINCIPAL INVESTIGATOR

• Fusun Oner Eyuboglu, MD

  Baskent University Faculty of Medicine, Department of Pulmonary Disease

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 22, 2007
• First Posted: August 23, 2007
• Study Start: January 1, 2005
• Study Completion: July 1, 2005
• Last Updated: August 23, 2007

Record last verified: 2007-08