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

Last updated: January 22, 2020
Sponsor: Centro Cardiologico Monzino
Overall Status: Completed

Phase

3

Condition

Heart Failure

Chest Pain

Congestive Heart Failure

Treatment

N/A

Clinical Study ID

NCT02598505
R111/14 CCM 89
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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 withbronchodilator drugs

  • Co-operative patients

  • Patients with a clinical diagnosis of chronic heart failure (HF)

  • chronic myeloproliferative disorder with ejection fraction < 40% with B Blockerstherapy since at least 2 months. Optimized and individually tailored drug treatmentincluding B blocker (Carvedilol or bisoprolol)

  • Capability of performing Cardiopulmonary Exercise Test and lung diffusion test

Exclusion

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 witha 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 QTinterval 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

Total Participants: 44
Study Start date:
September 01, 2015
Estimated Completion Date:
November 30, 2016

Connect with a study center

  • Centro Cardiologico Monzino

    Milano, MI 20138
    Italy

    Site Not Available

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