Effect of Right Bifocal Ventricular Cardiac Pacing on Serum Level Natriuretic Peptides in Patients With Heart Failure
Primary Purpose
Heart Failure
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Pacemaker Biotronik: apical stimulation
Pacemaker Biotronik: bifocal stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring atrial fibrillation, heart failure, pacemaker
Eligibility Criteria
Inclusion Criteria:
- Permanent atrial fibrillation with bradycardia and classic indication for permanent pacemaker
- mild or moderate ventricular dysfunction (35% <left ventricle ejection fraction <55%) of any etiology
- Signature of the free and informed consent
Exclusion Criteria:
- Age <18 years
- left ventricle ejection fraction > 55% or ≤ 35%
- classic indication of cardiac resynchronization therapy by Brazilian Guidelines for Cardiac Implantable Electronic Devices
- Patients with left ventricle ejection fraction ≤ 35%, with permanent atrial fibrillation, heart failure with functional class III or IV despite optimal pharmacological treatment and QRS> 150 ms
- Patients with left ventricle ejection fraction ≤ 35%, with permanent atrial fibrillation, heart failure with functional class III or IV despite optimal pharmacological treatment and QRS 120-150 ms with evidence of dyssynchrony by imaging method
- Patients with indication for pacemaker when ventricular pacing is essential, left ventricle ejection fraction ≤ 35% and heart failure with functional class III or IV
- Refusal to signing the informed consent
Sites / Locations
- Carolina Christianini MizzaciRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Apical stimulation
Bifocal stimulation
Arm Description
Pacemaker Biotronik: apical stimulation
Pacemaker Biotronik: bifocal stimulation
Outcomes
Primary Outcome Measures
Serum level of natriuretic peptides
Assess whether resynchronization achieved by bifocal right ventricle pacing has influence on serum levels of natriuretic peptides and whether this could be used as a marker of success.
Secondary Outcome Measures
Clinical parameters
We will compare clinical parameters by New York Heart Association functional classification
Electrocardiographic parameters
We will compare electrocardiographic parameters (QRS complex stimulated) in ventricular apical position and ventricular bifocal position
Assess quality of life
We will evaluate quality of life: Minnesota Living with Heart Failure Questionnaire
Full Information
NCT ID
NCT02186314
First Posted
June 16, 2014
Last Updated
August 1, 2016
Sponsor
Instituto Dante Pazzanese de Cardiologia
1. Study Identification
Unique Protocol Identification Number
NCT02186314
Brief Title
Effect of Right Bifocal Ventricular Cardiac Pacing on Serum Level Natriuretic Peptides in Patients With Heart Failure
Official Title
Effect of Right Bifocal Ventricular Cardiac Pacing on Serum Level Natriuretic Peptides in Patients With Heart Failure and Pacemaker Indication
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
February 2014 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
February 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Dante Pazzanese de Cardiologia
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
In this study we will select twenty patients with chronic atrial fibrillation and ventricular dysfunction with permanent cardiac pacemaker indication. We will dosage serum level natriuretic peptides for comparison between conventional and bifocal cardiac pacing.
Detailed Description
The target study population will comprise patients with permanent atrial fibrillation with mild or moderate myocardial dysfunction according to the American consensus echocardiography and the classical indication for pacemaker by Brazilian Guidelines for Cardiac Implantable Electronic Devices Guidelines and the American Heart Association. Primary goal: Assess whether resynchronization achieved by bifocal right ventricle pacing has influence on serum levels of natriuretic peptides and whether this could be used as a measure of success. Secondary goal: To compare clinical parameters,compare electrocardiographic parameters (QRS complex stimulated) in ventricular apical position and ventricular bifocal position, assess quality of life by questionnaire Minnesota Living With Heart Failure. Will be implanted pacemaker endocardial bifocal, with placement of a ventricular endocardial electrode in the septal region and another in right ventricle apical, as adopted in the conduct of Pacemaker sector under local anesthesia and sedation. After pacemaker implantation, patients will be randomized in a 1:1 ratio to apical or bifocal stimulation. Patients remained in this mode of stimulation for two months, after which they will be subjected to the following sequence of reviews: Clinical assessment (functional classification of heart failure);assessment of quality of life by the Minnesota Living With Heart Failure Questionnaire, 12-lead electrocardiogram at rest, with measurements of stimulated QRS duration, evaluation of the parameters of the pacemaker, serum level of peptides. At the end of this period of evaluation, patients will undergo cross-over groups, those in apical ventricular pacing will be allocated in the bifocal group and the last one will be allocated to apical ventricular pace. Patients will be retained in the new pacing mode for two months, and at the end of this period will be submitted to clinical, laboratory and assessment of pacemaker evaluation as well. At the end of the study, all patients will be kept in bifocal ventricular pacing, as advocated in the conduct of Pacemaker sector.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
atrial fibrillation, heart failure, pacemaker
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Apical stimulation
Arm Type
Active Comparator
Arm Description
Pacemaker Biotronik: apical stimulation
Arm Title
Bifocal stimulation
Arm Type
Active Comparator
Arm Description
Pacemaker Biotronik: bifocal stimulation
Intervention Type
Device
Intervention Name(s)
Pacemaker Biotronik: apical stimulation
Intervention Description
Patients with pacemaker (Biotronik): an electrode will be implanted in the apical position of the right ventricle and an electrode implanted in the septal position of the right ventricle.The patients will remained in apical stimulation for two months, after that they will be subjected to evaluation. At the end of the evaluation, patients will undergo cross-over groups( bifocal stimulation) and patients will be kept in the new pacing mode for two months when they will be submitted to clinical, laboratory evaluation and assessment of pacemaker
Intervention Type
Device
Intervention Name(s)
Pacemaker Biotronik: bifocal stimulation
Intervention Description
Patients with pacemaker (Biotronik): an electrode will be implanted in the apical position of the right ventricle and an electrode implanted in the septal position of the right ventricle.The patients will remained in bifocal stimulation for two months, after that they will be subjected to evaluation. At the end of the evaluation, patients will undergo cross-over groups( apical stimulation) and patients will be kept in the new pacing mode for two months, when they will be submitted to clinical, laboratory evaluation and assessment of pacemaker
Primary Outcome Measure Information:
Title
Serum level of natriuretic peptides
Description
Assess whether resynchronization achieved by bifocal right ventricle pacing has influence on serum levels of natriuretic peptides and whether this could be used as a marker of success.
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Clinical parameters
Description
We will compare clinical parameters by New York Heart Association functional classification
Time Frame
2 months
Title
Electrocardiographic parameters
Description
We will compare electrocardiographic parameters (QRS complex stimulated) in ventricular apical position and ventricular bifocal position
Time Frame
2 months
Title
Assess quality of life
Description
We will evaluate quality of life: Minnesota Living with Heart Failure Questionnaire
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Permanent atrial fibrillation with bradycardia and classic indication for permanent pacemaker
mild or moderate ventricular dysfunction (35% <left ventricle ejection fraction <55%) of any etiology
Signature of the free and informed consent
Exclusion Criteria:
Age <18 years
left ventricle ejection fraction > 55% or ≤ 35%
classic indication of cardiac resynchronization therapy by Brazilian Guidelines for Cardiac Implantable Electronic Devices
Patients with left ventricle ejection fraction ≤ 35%, with permanent atrial fibrillation, heart failure with functional class III or IV despite optimal pharmacological treatment and QRS> 150 ms
Patients with left ventricle ejection fraction ≤ 35%, with permanent atrial fibrillation, heart failure with functional class III or IV despite optimal pharmacological treatment and QRS 120-150 ms with evidence of dyssynchrony by imaging method
Patients with indication for pacemaker when ventricular pacing is essential, left ventricle ejection fraction ≤ 35% and heart failure with functional class III or IV
Refusal to signing the informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carolina Mizzaci
Phone
11 966209622
Email
carolina.mizzaci@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
carolina Mizzaci
Organizational Affiliation
Instituto Dante Pazzanese de Cardiologia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Carolina Christianini Mizzaci
City
São Paulo
State/Province
SP
ZIP/Postal Code
04012909
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carolina Mizzaci
Phone
11 966209622
Email
carolina.mizzaci@hotmail.com
12. IPD Sharing Statement
Learn more about this trial
Effect of Right Bifocal Ventricular Cardiac Pacing on Serum Level Natriuretic Peptides in Patients With Heart Failure
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