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Completed

NCT Number: NCT01886430

Effects of Low-frequency Electrical Stimulation in Patients With Advanced HF

The purpose of this study is to verify the effects of low frequency functional electrical stimulation in heart failure patients hospitalized for treatment of the syndrome.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto do Coração - HC/FMUSP

São Paulo, 05403-900, Brazil

About this study

The aim of this study is to assess the effects of low frequency functional electrical stimulation on control autonomic and peripheral function in heart failure patients hospitalized for treatment of the syndrome. A randomized clinical trial with 30 advanced heart failure patients will be randomly assigned to functional electrical stimulation (Functional EE, n= 15) e 2) sensory electrical stimulation (Sensory EE, n=15). The functional electrical stimulation will be applied in the rectus femoris, and gastrocnemius, with frequency of 10 Hz, pulse duration of 150 ms, stimulation time (time on) of 20 seconds, resting time (time off) of 20 seconds and intensity according to the discomfort threshold of the patient , checked every day until achieve a maximum of 70mA. The session will last 60 minuts. It will be held every weekday for a period of 10 days. The effects of interventions on functional capacity, autonomic control, peripheral function, peripheral muscle strength and quality of life will be analyzed at baseline and at the end of the protocol.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with advanced heart failure,
  • Class Functional IV, according to the criteria of New York Heart Association (NYHA),
  • Aged over 18 years,
  • Etiology hypertensive, ischemic, idiopathic or chagas disease,
  • Left ventricular ejection fraction ≤ 30%.

Exclusion criteria

  • Patients with hypertension lung disease and oxygen-dependent,
  • Neurological and neuromuscular disease that presenting paresthesia or plegia of the lower limbs,
  • Insulin-dependent diabetes mellitus (type I),
  • Peripheral arterial occlusive disease,
  • Peripheral neuropathy,
  • Use of pacemaker or implantable cardiodefibrillator.

Treatment and study plan

Functional Electrical Stimulation

Other

Functional electrical stimulation for 10 days

Placebo electrical stimulation

Other

Placebo electrical stimulation for 10 days

Primary outcomes

  1. Functional assessment

    Time frame: 10 days

    To assess the effects of the functional electrical stimulation in patients with advanced heart failure.

Secondary outcomes

  1. Peripheral function

    Time frame: 10 days

    To assess the effects of the functional electrical stimulation in patients with advanced heart failure.

  2. Peripheral muscle strength

    Time frame: 10 days

    To assess the effects of the functional electrical stimulation in patients with advanced heart failure.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Collaborators

  • Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

Effects of Low-frequency Electrical Stimulation in Sympathetic Nerve Activity and Peripheral Vasoconstriction in Patients With Advanced HF

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Jun 25, 2013
Registry last updated
Dec 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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