Heart FailureNCT02186314
Effect of Right Bifocal Ventricular Cardiac Pacing on Serum Level Natriuretic Peptides in Patients With Heart Failure
A study testing Pacemaker Biotronik: apical stimulation and Pacemaker Biotronik: bifocal stimulation in people with Heart Failure, run by Instituto Dante Pazzanese de Cardiologia at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Pacemaker Biotronik: apical stimulation and Pacemaker Biotronik: bifocal stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2014to Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Carolina Christianini Mizzaci
São Paulo, São Paulo, 04012909
Carolina Mizzaci, 11 966209622, carolina.mizzaci@hotmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Heart Failure
- Being tested
- Pacemaker Biotronik: apical stimulation, Pacemaker Biotronik: bifocal stimulation
- Keywords
- atrial fibrillation, heart failure, pacemaker
- Medical subject headings
- Heart Failure, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pacemaker Biotronik: apical stimulationDevice
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
Pacemaker Biotronik: bifocal stimulationDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Apical stimulation | Active comparator | Pacemaker Biotronik: apical stimulation Receives: Device: Pacemaker Biotronik: apical stimulation; Device: Pacemaker Biotronik: bifocal stimulation |
| Bifocal stimulation | Active comparator | Pacemaker Biotronik: bifocal stimulation Receives: Device: Pacemaker Biotronik: apical stimulation; Device: Pacemaker Biotronik: bifocal stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 months
Secondary outcomes (3)
Clinical parameters
We will compare clinical parameters by New York Heart Association functional classification
Measured: 2 months
Electrocardiographic parameters
We will compare electrocardiographic parameters (QRS complex stimulated) in ventricular apical position and ventricular bifocal position
Measured: 2 months
Assess quality of life
We will evaluate quality of life: Minnesota Living with Heart Failure Questionnaire
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2014 (estimated)
- Study startFeb 2014
- Primary completionDec 2016 (estimated)
- Study completionFeb 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Dante Pazzanese de Cardiologia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carolina Crhistianini Mizzaci, Instituto Dante Pazzanese de Cardiologia
- Investigators
- carolina Mizzaci, Principal investigator, Instituto Dante Pazzanese de Cardiologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02186314
- Sponsor's protocol ID
- 4381
- Status last verified
- Aug 2016
- First submitted
- 16 Jun 2014
- Last updated
- 3 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Right Bifocal Ventricular Cardiac Pacing on Serum Level Natriuretic Peptides in Patients With Heart Failure and Pacemaker Indication
- ClinicalTrials.gov ID
- NCT02186314
- Acronym / sponsor ID
- 4381
- Conditions
- Heart Failure
- Keywords
- atrial fibrillation, heart failure, pacemaker
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Instituto Dante Pazzanese de CardiologiaUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Feb 2017 (estimated)
- First posted
- 10 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apical stimulation | Active comparator | Device: Pacemaker Biotronik: apical stimulation, Device: Pacemaker Biotronik: bifocal stimulationPacemaker Biotronik: apical stimulation |
| Bifocal stimulation | Active comparator | Device: Pacemaker Biotronik: apical stimulation, Device: Pacemaker Biotronik: bifocal stimulationPacemaker Biotronik: bifocal stimulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pacemaker Biotronik: apical stimulationPatients 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 | Apical stimulation, Bifocal stimulation |
| Pacemaker Biotronik: bifocal stimulationPatients 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 | Device | Apical stimulation, Bifocal stimulation |
Primary outcome
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.
3 secondary outcomes
Clinical parameters
Time frame: 2 months
Electrocardiographic parameters
Time frame: 2 months
Assess quality of life
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2016.
Related trials for Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
carolina Mizzaci principal investigator
Instituto Dante Pazzanese de Cardiologia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pacemaker Biotronik: apical stimulation and Pacemaker Biotronik: bifocal stimulation in people with Heart Failure, run by Instituto Dante Pazzanese de Cardiologia at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carolina Mizzaci (11 966209622, carolina.mizzaci@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum level of natriuretic peptides (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2016.