Cardiac Effects of Fixed-dose Dual Bronchodilator in Patients With Heart Insufficiency and COPD (CREATES)
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|ClinicalTrials.gov Identifier: NCT02812862|
Recruitment Status : Unknown
Verified June 2016 by RWTH Aachen University.
Recruitment status was: Recruiting
First Posted : June 24, 2016
Last Update Posted : August 9, 2016
The aim of this study is to evaluate the pulmonary and cardiac effects of a LABA / LAMA combination therapy in patients suffering from both chronic heart failure and chronic obstructive pulmonary disease.
The secondary aim of the study it to assess the safety of the LABA / LAMA combination.
|Condition or disease||Intervention/treatment|
|COPD||Drug: Ultibro/ Breezhaler|
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Cardiac Effects of Fixed-dose Dual Bronchodilator in Patients With Heart Insufficiency and COPD|
|Study Start Date :||August 2016|
|Estimated Primary Completion Date :||August 2017|
|Estimated Study Completion Date :||August 2018|
50 male and female patients suffering from chronic heart failure and chronic obstructive pulmonary disease.
Ultibro/ Breezhaler combination therapy
Drug: Ultibro/ Breezhaler
LABA/ LAMA combination therapy a combination of two bronchodilators acting on two separate pharmacological targets - one ß-agonist and one anti-muscarinergic agent
50 male and female patients suffering from chronic heart failure but not COPD and NOT receiving LAMA/ LABA
- Change in FEV1 [ Time Frame: 24 months ]
- comparison between treatment group and control group [ Time Frame: 24 months ]major adverse cardiac events, mortality & hospitalization
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): NCT02812862
|Contact: Michael Dreher, MD||+49 241 80 email@example.com|
|Contact: Christian Cornelissen, MD||+49 241 80 firstname.lastname@example.org|
|Clinic of Cardiology, Angiology, Pneumology and Intensive Medicine, University Hospital Aachen||Recruiting|
|Aachen, North Rhine Westphalia, Germany, 52074|
|Contact: Michael Dreher, MD +49 241 80 35002 email@example.com|
|Contact: Christian Cornelissen, MD +49 241 80 85060 firstname.lastname@example.org|
|Principal Investigator: Michael Dreher, MD|
|Principal Investigator:||Michael Dreher, MD||University Hospital RWTH Aachen|