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

C

Centro Cardiologico Monzino

Status and phase

Completed
Phase 3

Conditions

Heart Failure

Treatments

Drug: Indacaterol
Drug: Placebo

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT02598505
R111/14 CCM 89

Details and patient eligibility

About

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).

Enrollment

44 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

44 participants in 2 patient groups, including a placebo group

Indacaterol
Experimental group
Description:
Inside this arm we also compare the effect of Carvedilol to the effect of Bisoprolol
Treatment:
Drug: Indacaterol
Placebo
Placebo Comparator group
Description:
Inside this arm we also compare the effect of Carvedilol to the effect of Bisoprolol
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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