Clinical trial NCT02812862: Cardiac Effects of Spiolto®/Respimat® in Patients With Congestive Heart Failure and COPD
Official title: Cardiac Effects of Spiolto®/Respimat® in Patients With Congestive Heart Failure and COPD
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: COPD
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
First posted: 2016-06-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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)

Primary outcomes:
measure: To examine the change in Residual Volume (RV) V0-V2
timeFrame: 24 months
Secondary outcomes:
measure: To examine the change in trough FEV1
timeFrame: 24 months
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Clinic of Cardiology, Angiology, Pneumology and Intensive Medicine, University Hospital Aachen
state: North Rhine Westphalia
Study officials:
affiliation: University Hospital RWTH Aachen
name: Michael Dreher, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.