NCT01886430

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable heart-failure

Timeline
Completed

Started May 2009

Longer than P75 for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
completed

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

May 1, 2009

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

April 9, 2013

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 25, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

December 3, 2015

Status Verified

April 1, 2013

Enrollment Period

5.3 years

First QC Date

April 9, 2013

Last Update Submit

December 2, 2015

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

  • Functional assessment

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

    10 days

Secondary Outcomes (2)

  • Peripheral function

    10 days

  • Peripheral muscle strength

    10 days

Study Arms (2)

Functional Electrical Stimulation

EXPERIMENTAL

Functional Electrical Stimulation for 10 days

Other: Functional electrical stimulation

Control Electrical Stimulation

PLACEBO COMPARATOR

Control Electrical Stimulation for 10 days

Other: Placebo electrical stimulation

Interventions

Functional electrical stimulationOTHER

Functional electrical stimulation for 10 days

Functional Electrical Stimulation
Placebo electrical stimulationOTHER

Placebo electrical stimulation for 10 days

Control Electrical Stimulation

Eligibility Criteria

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

You may qualify if:

  • 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%.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto do Coração - HC/FMUSP

São Paulo, São Paulo, 05403-900, Brazil

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

April 9, 2013

First Posted

June 25, 2013

Study Start

May 1, 2009

Primary Completion

August 1, 2014

Study Completion

December 1, 2014

Last Updated

December 3, 2015

Record last verified: 2013-04

Locations

BR(1)