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Cardiac Effects of Spiolto®/Respimat® in Patients With Congestive Heart Failure and COPD (CREATES)

Primary Purpose

COPD

Status
Withdrawn
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Spiolto® Respimat® (Tiotropium / Olodaterol)
Sponsored by
RWTH Aachen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for COPD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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-III, mMRC Dyspnea score > 1)
  • Diagnosis of COPD (FEV1/FVC ratio <70%, FEV1 < 80%)
  • Patients with hyperinflation at rest defined as Residual Volume (RV) > 135 % predicted
  • Diagnosis of moderate symptomatic ischaemic Congestive heart failure (LVEF > 35 -45%)
  • Stability of CHF during the preceding 3 months (no hospitalization due to CHF, stable CHF medication)
  • 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 moderate-severe exacerbation of COPD, acute respiratory failure (pH < 7,35 and/ or respiratory rate > 30/min within 3 months prior to inclusion)
  • Unstable heart failure or planned change in medication (hospitalization due to CHF within 3 months prior to inclusion), any angina pectoris
  • Not symptomatic
  • Patient has been committed to an institution by legal or regulatory order
  • Participation in a parallel interventional clinical trial
  • Any COPD maintenance therapy before start of randomization
  • History or diagnosis of Asthma
  • LVEF <35 % or ICD or pacemaker
  • Myocardial infarction 6 months prior inclusion
  • History of life-threatening arrhythmias (e.g. NSVT or ventricular tachycardia, aFib, AV-Block, pacemaker treatment etc.)
  • History of diagnosis of Thyrotoxicosis
  • Chronic kidney disease with an crea-clearance ≤30 ml/min
  • History of significant alcohol or drug abuse, as judged by the Investigator
  • Fibrotic lung disease (e.g. IPF, ILD)
  • Contraindications for MRT (e.g. pacemaker, defibrillator, ferromagnetic metal implants, tattoos, claustrophobia, etc. according to MRI checklist used in the clinical routine)

Sites / Locations

  • Clinic of Cardiology, Angiology, Pneumology and Intensive Medicine, University Hospital Aachen

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment group

Arm Description

20 male and female patients suffering from chronic heart failure and chronic obstructive pulmonary disease. Patients will be treated with Spiolto® Respimat® (the LABA/ LAMA combination)

Outcomes

Primary Outcome Measures

To examine the change in Residual Volume (RV) V0-V2

Secondary Outcome Measures

To examine the change in trough FEV1
Time Points: values at V0 compared with V2

Full Information

First Posted
June 14, 2016
Last Updated
October 25, 2022
Sponsor
RWTH Aachen University
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1. Study Identification

Unique Protocol Identification Number
NCT02812862
Brief Title
Cardiac Effects of Spiolto®/Respimat® in Patients With Congestive Heart Failure and COPD
Acronym
CREATES
Official Title
Cardiac Effects of Spiolto®/Respimat® in Patients With Congestive Heart Failure and COPD
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Rationale obsolete
Study Start Date
August 2016 (undefined)
Primary Completion Date
August 2017 (Anticipated)
Study Completion Date
August 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RWTH Aachen University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study is to evaluate the pulmonary and cardiac effects of the LABA / LAMA combination Tiotropium / Olodaterol therapy in patients suffering from both congestive heart failure and chronic obstructive pulmonary disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment group
Arm Type
Experimental
Arm Description
20 male and female patients suffering from chronic heart failure and chronic obstructive pulmonary disease. Patients will be treated with Spiolto® Respimat® (the LABA/ LAMA combination)
Intervention Type
Drug
Intervention Name(s)
Spiolto® Respimat® (Tiotropium / Olodaterol)
Other Intervention Name(s)
Long-acting ß-agonist (LABA), Long-acting anti-muscarinergic agent (LAMA)
Intervention Description
LABA/ LAMA combination therapy: A combination of two bronchodilators acting on two separate pharmacological targets - one ß-agonist and one anti-muscarinergic agent.
Primary Outcome Measure Information:
Title
To examine the change in Residual Volume (RV) V0-V2
Time Frame
24 months
Secondary Outcome Measure Information:
Title
To examine the change in trough FEV1
Description
Time Points: values at V0 compared with V2
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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-III, mMRC Dyspnea score > 1) Diagnosis of COPD (FEV1/FVC ratio <70%, FEV1 < 80%) Patients with hyperinflation at rest defined as Residual Volume (RV) > 135 % predicted Diagnosis of moderate symptomatic ischaemic Congestive heart failure (LVEF > 35 -45%) Stability of CHF during the preceding 3 months (no hospitalization due to CHF, stable CHF medication) 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 moderate-severe exacerbation of COPD, acute respiratory failure (pH < 7,35 and/ or respiratory rate > 30/min within 3 months prior to inclusion) Unstable heart failure or planned change in medication (hospitalization due to CHF within 3 months prior to inclusion), any angina pectoris Not symptomatic Patient has been committed to an institution by legal or regulatory order Participation in a parallel interventional clinical trial Any COPD maintenance therapy before start of randomization History or diagnosis of Asthma LVEF <35 % or ICD or pacemaker Myocardial infarction 6 months prior inclusion History of life-threatening arrhythmias (e.g. NSVT or ventricular tachycardia, aFib, AV-Block, pacemaker treatment etc.) History of diagnosis of Thyrotoxicosis Chronic kidney disease with an crea-clearance ≤30 ml/min History of significant alcohol or drug abuse, as judged by the Investigator Fibrotic lung disease (e.g. IPF, ILD) Contraindications for MRT (e.g. pacemaker, defibrillator, ferromagnetic metal implants, tattoos, claustrophobia, etc. according to MRI checklist used in the clinical routine)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Dreher, MD
Organizational Affiliation
University Hospital RWTH Aachen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinic of Cardiology, Angiology, Pneumology and Intensive Medicine, University Hospital Aachen
City
Aachen
State/Province
North Rhine Westphalia
ZIP/Postal Code
52074
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23722616
Citation
Bateman ED, Ferguson GT, Barnes N, Gallagher N, Green Y, Henley M, Banerji D. Dual bronchodilation with QVA149 versus single bronchodilator therapy: the SHINE study. Eur Respir J. 2013 Dec;42(6):1484-94. doi: 10.1183/09031936.00200212. Epub 2013 May 30.
Results Reference
background
PubMed Identifier
23867808
Citation
Dahl R, Chapman KR, Rudolf M, Mehta R, Kho P, Alagappan VK, Chen H, Banerji D. Safety and efficacy of dual bronchodilation with QVA149 in COPD patients: the ENLIGHTEN study. Respir Med. 2013 Oct;107(10):1558-67. doi: 10.1016/j.rmed.2013.05.016. Epub 2013 Jul 16.
Results Reference
background

Learn more about this trial

Cardiac Effects of Spiolto®/Respimat® in Patients With Congestive Heart Failure and COPD

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