Electrical Stimulation Improves Exercise Tolerance in Patients With Advanced Heart Failure on Continuous Dobutamine Use

Not Applicable

Completed

• Conditions: Heart Failure; Ventricular Dysfunction, Left

• Registration Number: NCT02668419
• Lead Sponsor: Federal University of São Paulo

Brief Summary

The purpose of this study is to determine whether neuromuscular electrical stimulation can improve exercise tolerance for patients with heart failure and continuous dobutamine use in a hospital.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2016-01
• Study First Submitted: 2016-01-19
• Study First Submitted QC: 2016-01-28
• Last Update Submitted: 2016-01-28
• Study First Posted: 2016-01-29
• Last Update Posted: 2016-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

• Advanced heart failure (Stage D - Left ventricle ejection fraction <30%)
• New York Heart Association class III-IV
• Standard medical therapy for heart failure management
• Continuous inotropic infusion

Exclusion Criteria

• Unstable angina pectoris
• Recent (6 months) acute coronary syndrome
• Arrythmias
• Chronic renal failure
• Diabetes Mellitus
• Peripheral vascular diseases
• Inability to walk

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Functional capacity evaluated using the 6-minute walk test (6MWT)	Change from assessment at admission and at patient discharge	Functional capacity was evaluated using the 6-minute walk test (6MWT), by a single evaluator blinded to the group allotment, in accordance with American Thoracic Society criteria.

Secondary Outcome Measures

Name	Time	Method
Change in the intravenous inotropic support dosage	Change from the first day of the protocol and patient discharge	For all patients, the inotropic intravenous dose was adjusted daily by a single clinician (prescriber) blinded to the group allocation. Weaning from inotropic support was performed by the prescriber based on the improvement of clinical signs (level of consciousness, peripheral perfusion and blood pressure).

Trial Locations

Locations (1)

Federal University of Sao Paulo; 🇧🇷 Sao Paulo, Brazil