Indacaterol in Heart Failure Patients: Any Role on Lung Fluid Regulation

Study Overview
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Brief Summary
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The purposes of this study are: To confirm safety of Indacaterol in stable Heart Failure. To determine whether beta 2 alveolar receptor stimulation by Indacaterol is able to ameliorate lung diffusion in heart Failure patients treated with beta blockers. To compare the effects of Indacaterol in patients treated with a non-selective beta blocker (Carvedilol) and a beta 1-selective beta blocker (Bisoprolol).

Official Title
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Indacaterol in Heart Failure Patients: Any Role on Lung Fluid Regulation

Conditions
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Heart Failure

Intervention / Treatment
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* Drug: Indacaterol
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female adults aged ≥ 18 years who have signed an Informed Consent Form. 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: History or clinical documentation of: 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.

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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Indacaterol<br>Inside this arm we also compare the effect of Carvedilol to the effect of Bisoprolol | Drug: Indacaterol<br> <br> |
| Placebo Comparator: Placebo<br>Inside this arm we also compare the effect of Carvedilol to the effect of Bisoprolol | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measurement of change in lung diffusion of carbon monoxide (CO). | comparison of change in lung diffusion of carbon monoxide after treatment placebo/indacaterol between the carvedilol and bisoprolol groups. | day 0, 60, 74, 134 | 
| measurement of change in membrane diffusion (Dm) | comparison of change in mambrane diffusion (Dm) after treatment placebo/indacaterol between the carvedilol and bisoprolol groups. | day 0, 60, 74, 134 | 
| measurement of change in capillary volume (Vc) | comparison of change in Vc after treatment placebo/indacaterol between the carvedilol and bisoprolol groups. | day 0, 60, 74, 134 | 
| measurement of change in lung diffusion of NO (Nitric Oxide) | Measurement of change in lung diffusion of nitric oxide after treatment placebo/indacaterol between the carvedilol and bisoprolol groups. | day 0, 60, 74, 134 |