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Dental Anesthesia in Heart Failure Patients (DAHFP)

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ClinicalTrials.gov Identifier: NCT02228083
Recruitment Status : Unknown
Verified October 2015 by University of Sao Paulo General Hospital.
Recruitment status was:  Recruiting
First Posted : August 28, 2014
Last Update Posted : October 19, 2015
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
University of Sao Paulo General Hospital

Brief Summary:
To investigate the occurrence of arrhythmias in dental treatment with local anesthetic.

Condition or disease Intervention/treatment Phase
Heart Failure Drug: Lidocaine with epinephrine Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Occurrence of Heart Arrhythmia During Restorative Dental Procedure Under Local Anesthesia , in Heart Failure Pacients. A Double-blind Study
Study Start Date : September 2014
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : September 2017


Arm Intervention/treatment
Active Comparator: Safety of dental anesthesia
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.
Drug: Lidocaine with epinephrine
Lidocaine without vasoconstrictor , lidocaine with epinephrine 1:100,000

Oral health profile
An oral health profile of patients with heart failure will be described based in oral clinical examination.
Drug: Lidocaine with epinephrine
Lidocaine without vasoconstrictor , lidocaine with epinephrine 1:100,000




Primary Outcome Measures :
  1. Heart rate (bpm) [ Time Frame: 24 hours ]

    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.




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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02228083


Contacts
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Contact: Itamara LI Neves, PhD 55-11-26615229 itamara@incor.usp.br
Contact: Sergio ET Quaresma, MS 55-11-983890099 setquaresma@uol.com.br

Locations
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Brazil
Instituto do Coração HCFMUSP Recruiting
São Paulo, Brazil, 05403000
Contact: Itamara LI Neves, PhD    1126615229    itamara@incor.usp.br   
Contact: Sergio ET Quaresma, MS.    11983890099    setquaresma@uol.com.br   
Principal Investigator: Itamara LI Neves, PhD         
Sponsors and Collaborators
University of Sao Paulo General Hospital
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
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Principal Investigator: Itamara LI Neves, PhD Instituto do Coração do HCFMUSP
Study Director: Edimar A Bocchi, Habilitation Heart Institute of Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Study Chair: Ricardo S Neves, PhD Instituto do Coração do HCFMUSP
Study Chair: Sergio ET Quaresma, MS. Heart Institute of Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

Publications of Results:
Hunt SA, Abraham WT, Chin MH, Feldman AM, Francis GS, Ganiats TG, Jessup M, Konstam MA, Mancini DM, Michl K, Oates JA, Rahko PS, Silver MA, Stevenson LW, Yancy CW, Antman EM, Smith SC Jr, Adams CD, Anderson JL, Faxon DP, Fuster V, Halperin JL, Hiratzka LF, Jacobs AK, Nishimura R, Ornato JP, Page RL, Riegel B; American College of Cardiology; American Heart Association Task Force on Practice Guidelines; American College of Chest Physicians; International Society for Heart and Lung Transplantation; Heart Rhythm Society. ACC/AHA 2005 Guideline Update for the Diagnosis and Management of Chronic Heart Failure in the Adult: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Update the 2001 Guidelines for the Evaluation and Management of Heart Failure): developed in collaboration with the American College of Chest Physicians and the International Society for Heart and Lung Transplantation: endorsed by the Heart Rhythm Society. Circulation. 2005 Sep 20;112(12):e154-235. Epub 2005 Sep 13.

Other Publications:
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Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT02228083     History of Changes
Other Study ID Numbers: InsufCard
First Posted: August 28, 2014    Key Record Dates
Last Update Posted: October 19, 2015
Last Verified: October 2015
Keywords provided by University of Sao Paulo General Hospital:
dental
epinephrine
local anesthetic
lidocaine
cardiac arrhythmias
procedure
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
Lidocaine
Epinephrine
Racepinephrine
Anesthetics
Epinephryl borate
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents