Efficacy and Safety of Upfront Combination of ΒΟsentan and ΤΑdalafil in Pulmonary Arterial Hypertension (BOTA-PAH)
|Study Design:||Observational Model: Other
Time Perspective: Prospective
|Official Title:||An Observational, Non-interventional, Multicenter Study to Evaluate the Efficacy and Safety of Upfront Combination of Bosentan and Tadalafil in Pulmonary Arterial Hypertension in Greek Patients|
- Change From Baseline in the N-Terminal Pro-B-Type Natriuretic Peptide at Month 6 [ Time Frame: 6 months ]N-Terminal Pro-B-Type Natriuretic Peptide (NT-proBNP) is a surrogate marker of heart failure. The geometric mean ratio will be calculated as the ratio between the month 6 value and the Baseline value and presented as percent change = 100 * (geometric mean ratio - 1). The Baseline value is the last value prior to administration of study drug; this may be prior to or on the day of study drug initiation.
- Number of Participants With First Adjudicated Clinical Failure (CF) Event [ Time Frame: 6 months ]Hospitalisation for Worsening PAH, Disease Progression, Unsatisfactory Clinical Response
- Time to first clinical worsening (TTCW) event [ Time Frame: 6 months ]TTCW defined as the number of days between first dose of study drug and the occurrence of a predefined clinical worsening event.
- Percentage of Participants With a Satisfactory Clinical Response at Month 6 [ Time Frame: 6 months ]A satisfactory clinical response at month 6 is defined as a participant who meets all of the following criteria: 10% improvement in 6MWD compared with Baseline;
- Change From Baseline in the World Health Organization Functional Class at month 6 [ Time Frame: 6 months ]Change From Baseline in the World Health Organization Functional Class Time Frame: Baseline and Month 6 The WHO Functional Class (FC) indicates the severity of PAH and is an adaptation of the New York Heart Association classification.
- Change From Baseline in the 6 Minute Walk Distance (6MWD) Test at month 6 [ Time Frame: 6 months ]
Change From Baseline in the 6 Minute Walk Distance (6MWD) Test at month 6
MWD is the distance a participant can walk in 6 minutes. The 6-minute walk distance (6MWD) test measures the distance that a participant can walk in a period of 6 minutes.
- Change From Baseline in Borg Dyspnea Index at month 6 [ Time Frame: 6 months ]Borg Dyspnea Index (BDI) indicates the degree of breathlessness after completion of the 6 minute walk test.
- Quality of Life [ Time Frame: 6 moths ]Change in emPHasis-10 questionnaire score
|Anticipated Study Start Date:||December 1, 2017|
|Estimated Study Completion Date:||December 1, 2019|
|Estimated Primary Completion Date:||December 1, 2019 (Final data collection date for primary outcome measure)|
The primary objective of BOTA study is to compare the change in clinical and hemodynamic measures of PAH after the initiation of first line combination therapy with bosentan and tadalafil in adult patients with PAH. The safety and tolerability of first line combination therapy will also be evaluated.
In patients with PAH initial upfront combination treatment with bosentan and tadalafil
- Exercise capacity as expressed by distance walked in six minute walk test and WHO functional class
- Hemodynamics in terms of pulmonary vascular resistance (PVR), mean pulmonary artery pressure (mPAP) reduction and cardiac index (CI) elevation
- Quality of life
- NTproBNP serum levels
- Echocardiographic prognostic parameters such as right atrial area and presence of pericardial effusion.
Is safe as assessed by
- Liver function markers such as serum SGOT and SGPT levels
- Hemoglobin levels
Please refer to this study by its ClinicalTrials.gov identifier: NCT03139084
|Contact: George Giannakoulas, MDemail@example.com|