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

COPD Clinical Trial

— CREATES  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02812862
• Other study ID #: 15-165
• Status: Withdrawn
• Phase: Phase 4
• Start date: August 2016
• Est. completion date: August 2018

Study information

• Verified date: October 2022
• Source: RWTH Aachen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2018
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• COPD
• Heart Failure

Intervention

Drug:
• Spiolto® Respimat® (Tiotropium / Olodaterol)
LABA/ LAMA combination therapy: A combination of two bronchodilators acting on two separate pharmacological targets - one ß-agonist and one anti-muscarinergic agent.

Locations

Country	Name	City	State
Germany	Clinic of Cardiology, Angiology, Pneumology and Intensive Medicine, University Hospital Aachen	Aachen	North Rhine Westphalia

Sponsors (1)

Lead Sponsor	Collaborator
RWTH Aachen University

Country where clinical trial is conducted

Germany, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To examine the change in Residual Volume (RV) V0-V2		24 months
Secondary	To examine the change in trough FEV1	Time Points: values at V0 compared with V2	24 months