Upfront Combination Pulmonary Arterial Hypertension Therapy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03809156|
Recruitment Status : Recruiting
First Posted : January 18, 2019
Last Update Posted : March 26, 2020
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Hypertension||Drug: Riociguat Oral Product||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Upfront Riociguat and Ambrisentan Combination Therapy for Pulmonary Arterial Hypertension: A Safety and Efficacy Pilot Study|
|Actual Study Start Date :||April 26, 2016|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||January 31, 2021|
Experimental: Combo Riociguat and Ambrisentan Therapy
Riociguat Oral Product and Ambrisentan Oral Product to be given in combination to de novo (untreated) patients.
Drug: Riociguat Oral Product
Dual therapy of Riociguat and Ambrisentan at initiation of treatment.
Other Name: Ambrisentan Oral Product
- Pulmonary Vascular resistance [ Time Frame: 4 and 12 months ]Change from baseline to month 4 and month 12 in pulmonary vascular resistance (PVR) as assessed by Right Heart Catheterization.
- Hemodynamic Variables [ Time Frame: 4 and 12 months ]Change in hemodynamic variables (mPAP, RAP, CI) from baseline to month 4 and month 12 as assessed by Right Heart Catheterization.
- Echocardiographic parameters [ Time Frame: 4 and 12 months ]Change in echocardiographic parameters (TAPSE, RV strain, Tei index, Left ventricular Eccentricity index, RV:LV area ratio) as assessed by Echocardiogram.
- RV function [ Time Frame: 4 and 12 months ]Change from baseline to month 4 in RV function as assessed by cardiac MRI.
- NT-PRo-BNP [ Time Frame: 4 and 12 Months ]Change from baseline NT-PRo-BNP value from baseline to month 4 and month 12
- Exercise capacity [ Time Frame: 4 and 12 months ]Change from baseline to month 4 and month 12 in exercise capacity assessed by the 6 minute walk test
- Dyspnea [ Time Frame: 4 and 12 months ]Change from baseline to month 4 and month 12 in dyspnea as assessed by study questionnaire.
- Quality of Life Assessment [ Time Frame: 4 and 12 months ]Change from baseline to month 4 and month 12 in quality of life as assessed by study questionnaire.
- Functional Class [ Time Frame: 4 and 12 months ]Change from baseline to month 4 and month 12 in functional class as assessed by study questionnaire.
- Survival [ Time Frame: 12 months ]Survival at 12 months
- Clinical worsening [ Time Frame: 12 months ]Time to clinical worsening over 12 months
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03809156
|Contact: Naushad Hirani, MD||403 943 4759|
|Contact: Jean Marks, BN||(403) 943 firstname.lastname@example.org|
|Peter Lougheed Center||Recruiting|
|Calgary, Alberta, Canada, T1Y 6J4|
|Contact: Naushad Hirani, MD 403 943 4759|
|Canada, British Columbia|
|Vancouver General Hospital, The Lung Centre||Recruiting|
|Vancouver, British Columbia, Canada, V5Z 1M9|
|Contact: John Swiston, MD (604) 875 4122 email@example.com|
|Contact: Mami Okada (604) 875 4111 ext 69831 firstname.lastname@example.org|
|Sub-Investigator: John Swiston, MD|
|Principal Investigator:||Naushad Hirani, MD||University of Calgary|