Prognostic Value of Sympathetic Modulation in Patients With Heart Failure

Heart Failure Clinical Trial

Official title:

Prognostic Value of Oscillatory Pattern of Sympathetic Nerve Activity Muscle in Patients With Heart Failure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02047409
• Other study ID #: EDT-13001-PD
• Secondary ID: 2013/07651-72010
• Status: Recruiting
• Phase: N/A
• First received: January 24, 2014
• Last updated: September 18, 2015
• Start date: October 2013
• Est. completion date: October 2016

Study information

• Verified date: September 2015
• Source: University of Sao Paulo General Hospital
• Contact: Edgar Toschi Dias, PhD
• Phone: 55 11 2661-5099
• Email: edgar.dias[@]incor.usp.br
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The purpose of this study is to determine whether oscillatory pattern of sympathetic nerve activity muscle is an efficient index for the prognosis of patients with heart failure.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients with systolic heart failure and New York Heart Association (NYHA)

• Ischemic, hypertensive, or idiopathic etiology

• Left ventricular ejection fraction less than 40%

Exclusion Criteria:

• Neuromuscular, Orthopedic, Neurologic and Pulmonary Diseases

• Renal failure

• Diabetes mellitus type II

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Heart Failure

Locations

Country	Name	City	State
Brazil	Heart Institute (InCor), University of Sao Paulo, School of Medicine.	São Paulo

Sponsors (3)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital	Fundação de Amparo à Pesquisa do Estado de São Paulo, InCor Heart Institute

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peripheral autonomic control	Evaluate if the reduction in the oscillatory pattern of muscle sympathetic nerve activity is associated with morbidity and mortality in patients with heart failure in a clinical follow-up 12 months	12 months	No
Secondary	Arterial baroreflex control		12 months	No
Secondary	Blood inflammatory markers		12 months	No
Secondary	Cardiac and peripheral autonomic control		12 months	No
Secondary	Functional Capacity		12 months	No