- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02598505
Indacaterol in Heart Failure Patients: Any Role on Lung Fluid Regulation
January 22, 2020 updated by: Piergiuseppe Agostoni, Centro Cardiologico Monzino
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).
Study Overview
Study Type
Interventional
Enrollment (Actual)
44
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
MI
-
Milano, MI, Italy, 20138
- Centro Cardiologico Monzino
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Indacaterol
Inside this arm we also compare the effect of Carvedilol to the effect of Bisoprolol
|
|
Placebo Comparator: Placebo
Inside this arm we also compare the effect of Carvedilol to the effect of Bisoprolol
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
day 0, 60, 74, 134
|
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.
|
day 0, 60, 74, 134
|
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.
|
day 0, 60, 74, 134
|
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.
|
day 0, 60, 74, 134
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Piergiuseppe Agostoni, MD, Centro Cardiologico Monzino
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2015
Primary Completion (Actual)
November 1, 2016
Study Completion (Actual)
November 1, 2016
Study Registration Dates
First Submitted
October 22, 2015
First Submitted That Met QC Criteria
November 4, 2015
First Posted (Estimate)
November 6, 2015
Study Record Updates
Last Update Posted (Actual)
January 27, 2020
Last Update Submitted That Met QC Criteria
January 22, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R111/14 CCM 89
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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