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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02598505
• Other study ID #: R111/14 CCM 89
• Status: Completed
• Phase: Phase 3
• Start date: September 2015
• Est. completion date: November 2016

Study information

• Verified date: January 2020
• Source: Centro Cardiologico Monzino
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure

Intervention

Drug:
• Indacaterol

• Placebo

Locations

Country	Name	City	State
Italy	Centro Cardiologico Monzino	Milano	MI

Sponsors (2)

Lead Sponsor	Collaborator
Centro Cardiologico Monzino	Novartis

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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