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

• Status: Completed
• Trial end date: 2016-11-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centro Cardiologico Monzino
• Collaborator: Novartis

Criteria

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.