CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 20 enrolled
Drug / intervention
bosentan +1 moredrug
Likely dose
bosentan 62,5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00820352
NCT00820352Phase 3Completed

Endothelin Receptor Blockade in Heart Failure With Diastolic Dysfunction and Pulmonary Hypertension

University Teaching Hospital Hall in Tirol·interventional·Posted Jan 12, 2009·Updated Jun 30, 2014

In Brief

A Phase 3 clinical trial evaluating bosentan and placebo for Heart Failure, Diastolic and Hypertension, Pulmonary. Completed, enrolled 20 participants across 7 sites.

Detailed Summary

Heart failure is a major medical and socioeconomic problem in western industrial countries, especially with aging populations. Heart failure with normal left ventricle systolic function (heart failure with preserved ejection fraction, HFPEF, heart failure with normal ejection fraction, HFNEF) are common causes of hospitalization mainly in the elderly population and are frequently associated with pulmonary hypertension. It is commonly seen, that patients with left heart disease and pulmonary hypertension with right ventricle dysfunction have a worse prognosis. The investigators hypothesize, that an additional treatment with Bosentan in this patients will improve their exercise capacity, symptoms, hemodynamics and quality of life.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustria
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 12, 2009
Enrollment StartJan 1, 2009
Primary CompletionJun 1, 2014
TodayJul 2, 2026
Enrollment to primary: 5.4 yearsPosted 17.5 years ago

Interventions

bosentandrug

4 weeks of oral bosentan 62,5 mg b.i.d., followed by 8 weeks of 125 mg b.i.d.

placebodrug

placebo twice a day for 12 weeks