Prognostic Value of Sympathetic Modulation in Patients With Heart Failure

September 18, 2015 updated by: University of Sao Paulo General Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

160

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 05403-900
        • Recruiting
        • Heart Institute (InCor), University of Sao Paulo, School of Medicine.
        • Contact:
        • Contact:
          • Maria Urbana P B Rondon, PhD
          • Phone Number: 55 11 3091-8784
          • Email: urbana@usp.br
        • Principal Investigator:
          • Carlos Eduardo Negrao, PHD
        • Principal Investigator:
          • Maria Urbana P B Rondon, PhD
        • Sub-Investigator:
          • Maria Janieire N N Alves, MD PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The sample consisted of patients with heart failure in clinical follow up at the Heart Institute (InCor), University of São Paulo, School of Medicine.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peripheral autonomic control
Time Frame: 12 months
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

Secondary Outcome Measures

Outcome Measure
Time Frame
Arterial baroreflex control
Time Frame: 12 months
12 months
Blood inflammatory markers
Time Frame: 12 months
12 months
Cardiac and peripheral autonomic control
Time Frame: 12 months
12 months
Functional Capacity
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo
InCor Heart Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Anticipated)

October 1, 2016

Study Completion (Anticipated)

October 1, 2016

Study Registration Dates

First Submitted

January 24, 2014

First Submitted That Met QC Criteria

January 27, 2014

First Posted (Estimate)

January 28, 2014

Study Record Updates

Last Update Posted (Estimate)

September 22, 2015

Last Update Submitted That Met QC Criteria

September 18, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EDT-13001-PD
  • 2013/07651-7 (Other Identifier: FAPESP)
  • 2010/50048-1 (Other Identifier: FAPESP)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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