NCT02812862WithdrawnPhase 4
Cardiac Effects of Spiolto®/Respimat® in Patients With Congestive Heart Failure and COPD
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Withdrawn
- Sponsor
- RWTH Aachen University
- Locations
- 1
- Primary Endpoint
- To examine the change in Residual Volume (RV) V0-V2
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
Treatment group
Experimental
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)
Intervention: Spiolto® Respimat® (Tiotropium / Olodaterol) (Drug)
Outcomes
Primary Outcomes
To examine the change in Residual Volume (RV) V0-V2
Time Frame: 24 months
Secondary Outcomes
- To examine the change in trough FEV1(24 months)
Investigators
Study Sites (1)
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