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

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.

Study Overview

• Status: Withdrawn
• Conditions: COPD
• Intervention / Treatment: Drug: Spiolto® Respimat® (Tiotropium / Olodaterol)

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• Germany
  • North Rhine Westphalia
    • Aachen, North Rhine Westphalia, Germany, 52074
      • Clinic of Cardiology, Angiology, Pneumology and Intensive Medicine, University Hospital Aachen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group; 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)	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.; Other Names: Long-acting ß-agonist (LABA); Long-acting anti-muscarinergic agent (LAMA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To examine the change in Residual Volume (RV) V0-V2	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To examine the change in trough FEV1	Time Points: values at V0 compared with V2	24 months

Collaborators and Investigators

• Sponsor: RWTH Aachen University
• Investigators: Principal Investigator: Michael Dreher, MD, University Hospital RWTH Aachen

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (Anticipated): August 1, 2017
• Study Completion (Anticipated): August 1, 2018

Study Registration Dates

• First Submitted: June 14, 2016
• First Submitted That Met QC Criteria: June 21, 2016
• First Posted (Estimate): June 24, 2016

Study Record Updates

• Last Update Posted (Actual): October 27, 2022
• Last Update Submitted That Met QC Criteria: October 25, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Antagonists; Cholinergic Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Tiotropium Bromide; Olodaterol
• Other Study ID Numbers: 15-165

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No