Indacaterol in Heart Failure Patients: Any Role on Lung Fluid Regulation
NCT ID: NCT02598505
Last Updated: 2020-01-27
Study Results
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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COMPLETED
PHASE3
44 participants
INTERVENTIONAL
2015-09-30
2016-11-30
Brief Summary
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1. To confirm safety of Indacaterol in stable Heart Failure.
2. To determine whether beta 2 alveolar receptor stimulation by Indacaterol is able to ameliorate lung diffusion in heart Failure patients treated with beta blockers.
3. To compare the effects of Indacaterol in patients treated with a non-selective beta blocker (Carvedilol) and a beta 1-selective beta blocker (Bisoprolol).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Indacaterol
Inside this arm we also compare the effect of Carvedilol to the effect of Bisoprolol
Indacaterol
Placebo
Inside this arm we also compare the effect of Carvedilol to the effect of Bisoprolol
Placebo
Interventions
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Indacaterol
Placebo
Eligibility Criteria
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Inclusion Criteria
* Patients with light chronic obstructive pulmonary disease never treated with bronchodilator drugs
* Co-operative patients
* Patients with a clinical diagnosis of chronic heart failure (HF)
* chronic myeloproliferative disorder with ejection fraction \< 40% with B Blockers therapy since at least 2 months. Optimized and individually tailored drug treatment including B blocker (Carvedilol or bisoprolol)
* Capability of performing Cardiopulmonary Exercise Test and lung diffusion test
Exclusion Criteria
* pulmonary embolism
* primary valvular heart disease
* pericardial disease
* severe obstructive lung disease
* significant peripheral vascular disease
* exercise-induced angina, st changes, or severe arrhythmias.
* Patients with diabetes Type I or uncontrolled diabetes Type II including patients with a history of blood glucose levels consistently outside the normal range or HbA1c \> 8.0 % of total hemoglobin measured.
* Use of bronchodilators.
* Patients with a history (or family history) of long QT syndrome or whose corrected QT interval interval (Fridericia) measured at Visit 2 is prolonged: \>450 ms (males) or \>470 ms (females) as assessed by the central electrocardiogram (ECG) interpretation.
18 Years
ALL
No
Sponsors
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Novartis
INDUSTRY
Centro Cardiologico Monzino
OTHER
Responsible Party
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Piergiuseppe Agostoni
PhD
Principal Investigators
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Piergiuseppe Agostoni, MD
Role: PRINCIPAL_INVESTIGATOR
Centro Cardiologico Monzino
Locations
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Centro Cardiologico Monzino
Milan, MI, Italy
Countries
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Other Identifiers
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R111/14 CCM 89
Identifier Type: -
Identifier Source: org_study_id
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