NCT01252407

Brief Summary

The purpose of this study is to determine acute effect the transctutaneous electrical nerve stimulation in sympathetic and parassympathetic system in individuals with heart failure.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 1, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 3, 2010

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

August 2, 2012

Status Verified

November 1, 2010

Enrollment Period

2.3 years

First QC Date

December 1, 2010

Last Update Submit

August 1, 2012

Conditions

Improvement of Cardiovascular Autonomic ControlReduction of Levels of Catecholamines

Keywords

Transcutaneous electrical nerve stimulationSympathetic nervous systemParasympathetic nervous systemheart rate

Outcome Measures

Primary Outcomes (1)

  • differences in blood levels of catecholamines differences in blood levels of catecholamines differences in blood levels of catecholamines Differences in blood levels of catecholamines

    For evaluation of catecholamines (epinephrine, norepinephrine and dopamine) will be held one antecubital venipuncture and collected into tubes containing ethylenediaminetetraacetic acid (EDTA).

    one minute before and after transutaneous electrical nerve stimulation intervention (acute effect)

Secondary Outcomes (1)

  • improvement of heart rate variability

    one minute before and after transcutaneous electrical nerve stimulation intervention (acute effect)

Study Arms (1)

tens

EXPERIMENTAL
Other: transcutaneous electrical nerve stimulation

Interventions

transcutaneous electrical nerve stimulationOTHER

Application of low frequency (10-Hz) and high frequency (100-Hz) TENS, in two different days

tens

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Possess stable heart failure grade II or III according to NYHA;
  • Ejection fraction \<40% determined by echocardiography;
  • Having no change in drug therapy one month before being included in the study;
  • There have been Myocardial Infarction (AMI) three months before study entry;

You may not qualify if:

  • Patients with grade IV heart failure according to NYHA;
  • Acute respiratory;
  • Unstable angina;
  • Ventricular arrhythmia, unstable until three months before the start of the study;
  • Pacemaker;
  • Active smoking;
  • Diabetes mellitus;
  • And fever or infectious disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rodrigo Della Méa Plentz

Porto Alegre, Rio Grande do Sul, Brazil

Location

MeSH Terms

Interventions

Transcutaneous Electric Nerve Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and Analgesia

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 1, 2010

First Posted

December 3, 2010

Study Start

November 1, 2010

Primary Completion

March 1, 2013

Study Completion

December 1, 2013

Last Updated

August 2, 2012

Record last verified: 2010-11

Locations

BR(1)