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

Centro Cardiologico Monzino

Status and phase

Completed

Phase 3

Conditions

Heart Failure

Treatments

Drug: Indacaterol

Drug: Placebo

Study type

Interventional

Funder types

Other

Industry

Identifiers

R111/14 CCM 89

Details and patient eligibility

About

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).

Enrollment

44 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.