Cardiac Effects of Fixed-dose Dual Bronchodilator in Patients With Heart Insufficiency and COPD

• Status: Unknown status
• Trial end date: 2018-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: RWTH Aachen University
• Treatments: Bronchodilator Agents

Criteria

Inclusion Criteria:

• Adults who are contractually capable and mentally able to understand and follow the instructions of the study personnel

• Symptomatic with regard to dyspnea (NYHA II and more)

• Treatment group: COPD (FEV1/FVC ratio <70%, FEV1 < 80%)

• Control group: No COPD, no LAMA or LABA

• Chronic heart failure (ejection fraction < 40%)

• Stability of CHF during the preceding 3 months

• Male or female aged > 18 years

• Written informed consent prior to study participation

• The subject is willing and able to follow the procedures outlined in the protocol

Exclusion Criteria:

• Lack of informed consent

• Pregnant and lactating females

• Acute exacerbation of COPD, acute respiratory failure (pH < 7,35 and/ or respiratory rate > 30/min)

• Unstable heart failure or planned change in medication

• Not symptomatic

• Patient has been committed to an institution by legal or regulatory order

• Participation in a parallel interventional clinical trial