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

Primary Purpose

Heart Failure

Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Indacaterol
Placebo
Sponsored by
Centro Cardiologico Monzino
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Centro Cardiologico Monzino

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Indacaterol

Placebo

Arm Description

Inside this arm we also compare the effect of Carvedilol to the effect of Bisoprolol

Inside this arm we also compare the effect of Carvedilol to the effect of Bisoprolol

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
October 22, 2015
Last Updated
January 22, 2020
Sponsor
Centro Cardiologico Monzino
Collaborators
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT02598505
Brief Title
Indacaterol in Heart Failure Patients: Any Role on Lung Fluid Regulation
Official Title
Indacaterol in Heart Failure Patients: Any Role on Lung Fluid Regulation
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
September 2015 (Actual)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centro Cardiologico Monzino
Collaborators
Novartis

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purposes of this study are: To confirm safety of Indacaterol in stable Heart Failure. To determine whether beta 2 alveolar receptor stimulation by Indacaterol is able to ameliorate lung diffusion in heart Failure patients treated with beta blockers. To compare the effects of Indacaterol in patients treated with a non-selective beta blocker (Carvedilol) and a beta 1-selective beta blocker (Bisoprolol).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Indacaterol
Arm Type
Experimental
Arm Description
Inside this arm we also compare the effect of Carvedilol to the effect of Bisoprolol
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Inside this arm we also compare the effect of Carvedilol to the effect of Bisoprolol
Intervention Type
Drug
Intervention Name(s)
Indacaterol
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
measurement of change in lung diffusion of carbon monoxide (CO).
Description
comparison of change in lung diffusion of carbon monoxide after treatment placebo/indacaterol between the carvedilol and bisoprolol groups.
Time Frame
day 0, 60, 74, 134
Title
measurement of change in membrane diffusion (Dm)
Description
comparison of change in mambrane diffusion (Dm) after treatment placebo/indacaterol between the carvedilol and bisoprolol groups.
Time Frame
day 0, 60, 74, 134
Title
measurement of change in capillary volume (Vc)
Description
comparison of change in Vc after treatment placebo/indacaterol between the carvedilol and bisoprolol groups.
Time Frame
day 0, 60, 74, 134
Title
measurement of change in lung diffusion of NO (Nitric Oxide)
Description
Measurement of change in lung diffusion of nitric oxide after treatment placebo/indacaterol between the carvedilol and bisoprolol groups.
Time Frame
day 0, 60, 74, 134

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Piergiuseppe Agostoni, MD
Organizational Affiliation
Centro Cardiologico Monzino
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro Cardiologico Monzino
City
Milano
State/Province
MI
ZIP/Postal Code
20138
Country
Italy

12. IPD Sharing Statement

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

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