Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
RWTH Aachen University

Brief 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.


Condition or disease Intervention/treatment
COPD Drug: Ultibro/ Breezhaler

Layout table for study information
Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Group/Cohort Intervention/treatment
treatment group

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
Other Names:
  • Long-acting ß-agonist (LABA)
  • Long-acting anti-muscarinergic agent (LAMA)

control group
50 male and female patients suffering from chronic heart failure but not COPD and NOT receiving LAMA/ LABA



Primary Outcome Measures :
  1. Change in FEV1 [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. comparison between treatment group and control group [ Time Frame: 24 months ]
    major adverse cardiac events, mortality & hospitalization



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

50 male and female patients suffering from chronic heart failure and chronic obstructive pulmonary disease.

50 male and female patients suffering from chronic heart failure but not COPD and NOT receiving LAMA/ LABA

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

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Michael Dreher, MD +49 241 80 88763 mdreher@ukaachen.de
Contact: Christian Cornelissen, MD +49 241 80 85060 ccornelissen@ukaachen.de

Locations
Layout table for location information
Germany
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    mdreher@ukaachen.de   
Contact: Christian Cornelissen, MD    +49 241 80 85060    ccornelissen@ukaachen.de   
Principal Investigator: Michael Dreher, MD         
Sponsors and Collaborators
RWTH Aachen University
Investigators
Layout table for investigator information
Principal Investigator: Michael Dreher, MD University Hospital RWTH Aachen
Publications:
Layout table for additonal information
Responsible Party: RWTH Aachen University
ClinicalTrials.gov Identifier: NCT02812862    
Other Study ID Numbers: 15-165
First Posted: June 24, 2016    Key Record Dates
Last Update Posted: August 9, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Failure
Heart Diseases
Cardiovascular Diseases