Skip to main content
OpenTrials
Completed

NCT Number: NCT02598505

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Centro Cardiologico Monzino

Milan, MI, 20138, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Indacaterol

Drug

Placebo

Drug

Primary outcomes

  1. measurement of change in lung diffusion of carbon monoxide (CO).

    Time frame: day 0, 60, 74, 134

    comparison of change in lung diffusion of carbon monoxide after treatment placebo/indacaterol between the carvedilol and bisoprolol groups.

  2. measurement of change in membrane diffusion (Dm)

    Time frame: day 0, 60, 74, 134

    comparison of change in mambrane diffusion (Dm) after treatment placebo/indacaterol between the carvedilol and bisoprolol groups.

  3. measurement of change in capillary volume (Vc)

    Time frame: day 0, 60, 74, 134

    comparison of change in Vc after treatment placebo/indacaterol between the carvedilol and bisoprolol groups.

  4. measurement of change in lung diffusion of NO (Nitric Oxide)

    Time frame: day 0, 60, 74, 134

    Measurement of change in lung diffusion of nitric oxide after treatment placebo/indacaterol between the carvedilol and bisoprolol groups.

Sponsors and collaborators

Lead sponsor

Centro Cardiologico Monzino

Other

Collaborators

  • Novartis

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Nov 6, 2015
Registry last updated
Jan 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.