Heart Failure
Conditions
Brief summary
The purposes of this study are: 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).
Interventions
DRUGIndacaterol
DRUGPlacebo
Sponsors
Novartis
Centro Cardiologico Monzino
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| measurement of change in lung diffusion of carbon monoxide (CO). | day 0, 60, 74, 134 | comparison of change in lung diffusion of carbon monoxide after treatment placebo/indacaterol between the carvedilol and bisoprolol groups. |
| measurement of change in membrane diffusion (Dm) | day 0, 60, 74, 134 | comparison of change in mambrane diffusion (Dm) after treatment placebo/indacaterol between the carvedilol and bisoprolol groups. |
| measurement of change in capillary volume (Vc) | day 0, 60, 74, 134 | comparison of change in Vc after treatment placebo/indacaterol between the carvedilol and bisoprolol groups. |
| measurement of change in lung diffusion of NO (Nitric Oxide) | day 0, 60, 74, 134 | Measurement of change in lung diffusion of nitric oxide after treatment placebo/indacaterol between the carvedilol and bisoprolol groups. |
Countries
Italy
Outcome results
None listed