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

Phase 3

Completed

• Conditions: Heart Failure
• Interventions: Drug: Placebo; Drug: Indacaterol

• Registration Number: NCT02598505
• Lead Sponsor: Centro Cardiologico Monzino

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-10-22
• Study First Submitted QC: 2015-11-04
• Study First Posted: 2015-11-06
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-22
• Last Update Posted: 2020-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Inside this arm we also compare the effect of Carvedilol to the effect of Bisoprolol
Indacaterol	Indacaterol	Inside this arm we also compare the effect of Carvedilol to the effect of Bisoprolol

Primary Outcome Measures

Name	Time	Method
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 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 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.

Trial Locations

Locations (1)

Centro Cardiologico Monzino; 🇮🇹 Milano, MI, Italy