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Dental Anesthesia in Heart Failure Patients (DAHFP)

Primary Purpose

Heart Failure

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Lidocaine with epinephrine
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring dental, epinephrine, local anesthetic, lidocaine, cardiac arrhythmias, procedure

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • any race,nationality,profession, single or married.
  • class II , III or IV of New York heart Association ( NYHA)
  • minimum 45% ventricular ejection fraction
  • patient must be in a clinical treatment or hospital treatment
  • patient must need dental restorative treatment , mandible or maxilla, due to caries or need for substitution of a inadequate dental filling.

Exclusion Criteria:

  • patients with history of heart attack within less than three months
  • acute myocardial infarction
  • unstable angina
  • significant ventricular dysfunction
  • severe ventricular arrhythmia
  • malignant hypertension
  • neoplasms
  • sepsis
  • pregnancy
  • allergy to lidocaine and epinephrine

Sites / Locations

  • Instituto do Coração HCFMUSPRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Safety of dental anesthesia

Oral health profile

Arm Description

Application of local dental anesthesia with two cartridges (5,6 mL) of the lidocaine 2% with epinephrine 1:100.000 in heart failure patients in functional class III or IV.

An oral health profile of patients with heart failure will be described based in oral clinical examination.

Outcomes

Primary Outcome Measures

Heart rate (bpm)
The continuous electrocardiogram recording for a period of 24 hours will be obtained through the Holter monitor model Seer Ligth (GE), with three channels (seven-way) cable, installed a half hour before the dental procedure. The first analysis will be done automatically by the computer system, followed by visual and manual review at which supraventricular and ventricular premature heartbeats will be filtered accurately. Electrocardiographic variables are: heart rate maximum, minimum and mean HR, supraventricular extrasystole (VES) and ventricular (EV) FC. The program shall provide the record in HR per minute for 24 hours. The average individual will be calculated for the period studied, to then calculate the sample mean and groups LSA and LCA. The ESV and EV will be identified in tracing obtained every minute. Consider the valid values recorded HR and ischemic episodes; analyze the occurrence of EV and ESV occurring in number> 10 per hour in both groups, by study period.

Secondary Outcome Measures

Full Information

First Posted
August 26, 2014
Last Updated
October 15, 2015
Sponsor
University of Sao Paulo General Hospital
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT02228083
Brief Title
Dental Anesthesia in Heart Failure Patients
Acronym
DAHFP
Official Title
Occurrence of Heart Arrhythmia During Restorative Dental Procedure Under Local Anesthesia , in Heart Failure Pacients. A Double-blind Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
September 2016 (Anticipated)
Study Completion Date
September 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sao Paulo General Hospital
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To investigate the occurrence of arrhythmias in dental treatment with local anesthetic.
Detailed Description
Heart failure is defined as the inability of the heart to offer blood supply required to meet metabolic demand of the tissues and thus exercise adequately its role as a pump. According to data collected from the single health system (DATASUS), approximately 6.4 million Brazilians have heart failure. This large contingent of patients will require multi-professional treatment, in particular, careful with dental health heart failure is regarded as the final common pathway of most cardiovascular diseases and, after installation of symptoms (mainly in the stages of functional class NYHA III and IV) have poor prognosis with average survival of 1.7 years 3.2 years for men and for women. Dental treatment often requires application of local anesthetic. The adrenaline, agent vasoconstrictor, is widely used in dental treatment and aims to extend the effect of local anesthetic. Specifically in people with heart failure, there shortcomings of evidence in the literature, the harmful effects of adrenaline 1:100,000 added to the local anaesthetic lidocaine. Among the potential complications, we can highlight: arrhythmias, systemic blood pressure elevation and elevation of heart rate. The main objective of this work will investigate the occurrence of arrhythmias by evaluating of electrocardiographic parameters. Our secondary objectives will be assessing: variations of blood pressure by ambulatory blood pressure monitoring, cardiac frequency and chest pain. We will study 70 patients between 18 and 75 years with a diagnosis of congestive heart failure functional class NYHA III and IV and restorative dental treatment indication. A random picture in double-blind study, patients are divided into two groups, one group receives as local anesthetic lidocaine 2% with adrenaline 1 in comparison with the second group that will receive 2% lidocaine with vasoconstrictor.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
dental, epinephrine, local anesthetic, lidocaine, cardiac arrhythmias, procedure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Safety of dental anesthesia
Arm Type
Active Comparator
Arm Description
Application of local dental anesthesia with two cartridges (5,6 mL) of the lidocaine 2% with epinephrine 1:100.000 in heart failure patients in functional class III or IV.
Arm Title
Oral health profile
Arm Type
Other
Arm Description
An oral health profile of patients with heart failure will be described based in oral clinical examination.
Intervention Type
Drug
Intervention Name(s)
Lidocaine with epinephrine
Intervention Description
Lidocaine without vasoconstrictor , lidocaine with epinephrine 1:100,000
Primary Outcome Measure Information:
Title
Heart rate (bpm)
Description
The continuous electrocardiogram recording for a period of 24 hours will be obtained through the Holter monitor model Seer Ligth (GE), with three channels (seven-way) cable, installed a half hour before the dental procedure. The first analysis will be done automatically by the computer system, followed by visual and manual review at which supraventricular and ventricular premature heartbeats will be filtered accurately. Electrocardiographic variables are: heart rate maximum, minimum and mean HR, supraventricular extrasystole (VES) and ventricular (EV) FC. The program shall provide the record in HR per minute for 24 hours. The average individual will be calculated for the period studied, to then calculate the sample mean and groups LSA and LCA. The ESV and EV will be identified in tracing obtained every minute. Consider the valid values recorded HR and ischemic episodes; analyze the occurrence of EV and ESV occurring in number> 10 per hour in both groups, by study period.
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: any race,nationality,profession, single or married. class II , III or IV of New York heart Association ( NYHA) minimum 45% ventricular ejection fraction patient must be in a clinical treatment or hospital treatment patient must need dental restorative treatment , mandible or maxilla, due to caries or need for substitution of a inadequate dental filling. Exclusion Criteria: patients with history of heart attack within less than three months acute myocardial infarction unstable angina significant ventricular dysfunction severe ventricular arrhythmia malignant hypertension neoplasms sepsis pregnancy allergy to lidocaine and epinephrine
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Itamara LI Neves, PhD
Phone
55-11-26615229
Email
itamara@incor.usp.br
First Name & Middle Initial & Last Name or Official Title & Degree
Sergio ET Quaresma, MS
Phone
55-11-983890099
Email
setquaresma@uol.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Itamara LI Neves, PhD
Organizational Affiliation
Instituto do Coração do HCFMUSP
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Edimar A Bocchi, Habilitation
Organizational Affiliation
Heart Institute of Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ricardo S Neves, PhD
Organizational Affiliation
Instituto do Coração do HCFMUSP
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sergio ET Quaresma, MS.
Organizational Affiliation
Heart Institute of Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Official's Role
Study Chair
Facility Information:
Facility Name
Instituto do Coração HCFMUSP
City
São Paulo
ZIP/Postal Code
05403000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Itamara LI Neves, PhD
Phone
1126615229
Email
itamara@incor.usp.br
First Name & Middle Initial & Last Name & Degree
Sergio ET Quaresma, MS.
Phone
11983890099
Email
setquaresma@uol.com.br
First Name & Middle Initial & Last Name & Degree
Itamara LI Neves, PhD

12. IPD Sharing Statement

Citations:
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Citation
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Citation
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Citation
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Dental Anesthesia in Heart Failure Patients

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