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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2018-08-31

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.

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Detailed Description

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Conditions

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COPD

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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)

Group Type EXPERIMENTAL

Spiolto® Respimat® (Tiotropium / Olodaterol)

Intervention Type DRUG

LABA/ LAMA combination therapy:

A combination of two bronchodilators acting on two separate pharmacological targets - one ß-agonist and one anti-muscarinergic agent.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Long-acting ß-agonist (LABA) Long-acting anti-muscarinergic agent (LAMA)

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No