NCT02047409

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

October 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 28, 2014

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

September 22, 2015

Status Verified

September 1, 2015

Enrollment Period

3 years

First QC Date

January 24, 2014

Last Update Submit

September 18, 2015

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • Arterial baroreflex control

    12 months

  • Blood inflammatory markers

    12 months

  • Cardiac and peripheral autonomic control

    12 months

  • Functional Capacity

    12 months

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • Patients with systolic heart failure and New York Heart Association (NYHA)
  • Ischemic, hypertensive, or idiopathic etiology
  • Left ventricular ejection fraction less than 40%

You may not qualify if:

  • Neuromuscular, Orthopedic, Neurologic and Pulmonary Diseases
  • Renal failure
  • Diabetes mellitus type II

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heart Institute (InCor), University of Sao Paulo, School of Medicine.

São Paulo, São Paulo, 05403-900, Brazil

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Central Study Contacts

Edgar Toschi Dias, PhD

CONTACT

55 11 2661-5099edgar.dias@incor.usp.br

Maria Urbana P B Rondon, PhD

CONTACT

55 11 3091-8784urbana@usp.br

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2014

First Posted

January 28, 2014

Study Start

October 1, 2013

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

September 22, 2015

Record last verified: 2015-09

Locations

BR(1)