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

RWTH Aachen University

Status and phase: Withdrawn; Phase 4

Conditions: COPD

Treatments: Drug: Spiolto® Respimat® (Tiotropium / Olodaterol)

Study type: Interventional

Funder types: Other

Identifiers

NCT02812862

15-165

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No 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)

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

0 participants in 1 patient group

Treatment group

Experimental group

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)

Treatment:

Drug: Spiolto® Respimat® (Tiotropium / Olodaterol)