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

Study Overview
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Brief Summary
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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.

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

Conditions
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COPD

Intervention / Treatment
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* Drug: Spiolto® Respimat® (Tiotropium / Olodaterol)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>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)<br>* LABA/ LAMA combination therapy: A combination of two bronchodilators acting on two separate pharmacological targets - one ß-agonist and one anti-muscarinergic agent.<br>* Other names: Long-acting anti-muscarinergic agent (LAMA);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |