NCT02598505

Brief Summary

The purposes of this study are:

  1. 1.To confirm safety of Indacaterol in stable Heart Failure.
  2. 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. 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at below P25 for phase_3 heart-failure

Timeline
Completed

Started Sep 2015

Shorter than P25 for phase_3 heart-failure

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 22, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 6, 2015

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

January 27, 2020

Status Verified

January 1, 2020

Enrollment Period

1.2 years

First QC Date

October 22, 2015

Last Update Submit

January 22, 2020

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (4)

  • 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.

    day 0, 60, 74, 134

  • measurement of change in membrane diffusion (Dm)

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

    day 0, 60, 74, 134

  • measurement of change in capillary volume (Vc)

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

    day 0, 60, 74, 134

  • 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.

    day 0, 60, 74, 134

Study Arms (2)

Indacaterol

EXPERIMENTAL

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

Drug: Indacaterol

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

IndacaterolDRUG
Indacaterol
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro Cardiologico Monzino

Milan, MI, 20138, Italy

Location

MeSH Terms

Conditions

Heart Failure

Interventions

indacaterol

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Piergiuseppe Agostoni, MD

    Centro Cardiologico Monzino

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

October 22, 2015

First Posted

November 6, 2015

Study Start

September 1, 2015

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

January 27, 2020

Record last verified: 2020-01

Locations

IT(1)