Effect of Right Bifocal Ventricular Cardiac Pacing on Serum Level Natriuretic Peptides in Patients With Heart Failure

August 1, 2016 updated by: Carolina Crhistianini Mizzaci, Instituto Dante Pazzanese de Cardiologia

Effect of Right Bifocal Ventricular Cardiac Pacing on Serum Level Natriuretic Peptides in Patients With Heart Failure and Pacemaker Indication

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Brazil
    • SP
      • São Paulo, SP, Brazil, 04012909

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:

  • 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

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
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Apical stimulation
Pacemaker Biotronik: apical stimulation
Device: Pacemaker Biotronik: apical stimulation
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
Device: Pacemaker Biotronik: bifocal stimulation
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
ACTIVE_COMPARATOR: Bifocal stimulation
Pacemaker Biotronik: bifocal stimulation
Device: Pacemaker Biotronik: apical stimulation
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
Device: Pacemaker Biotronik: bifocal stimulation
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum level of natriuretic peptides
Time Frame: 2 months
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.
2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical parameters
Time Frame: 2 months
We will compare clinical parameters by New York Heart Association functional classification
2 months
Electrocardiographic parameters
Time Frame: 2 months
We will compare electrocardiographic parameters (QRS complex stimulated) in ventricular apical position and ventricular bifocal position
2 months
Assess quality of life
Time Frame: 2 months
We will evaluate quality of life: Minnesota Living with Heart Failure Questionnaire
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Dante Pazzanese de Cardiologia

Investigators

  • Principal Investigator: carolina Mizzaci, Instituto Dante Pazzanese de Cardiologia

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

February 1, 2014

Primary Completion (ANTICIPATED)

December 1, 2016

Study Completion (ANTICIPATED)

February 1, 2017

Study Registration Dates

First Submitted

June 16, 2014

First Submitted That Met QC Criteria

July 7, 2014

First Posted (ESTIMATE)

July 10, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

August 3, 2016

Last Update Submitted That Met QC Criteria

August 1, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4381

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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