NCT02043431

Brief Summary

The purpose of this study is to develop a biobank containing samples of 2,000 patients treated in a tertiary cardiology hospital containing electronic medical records and genetic data in genome-wide scale for performing genetic association studies for validation and development of medical decision routines that help the clinical management of heart failure patients.

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
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2012

Longer than P75 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

August 1, 2012

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

January 20, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 23, 2014

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

February 23, 2018

Status Verified

January 1, 2018

Enrollment Period

6.3 years

First QC Date

January 20, 2014

Last Update Submit

February 21, 2018

Conditions

Heart Failure

Keywords

Heart failureElectronic medical recordsGenomicsBiobank

Outcome Measures

Primary Outcomes (1)

  • all cause mortality

    Deaths for all causes after 6 months of inclusion. Deaths for all causes after 12 months of inclusion

    six and twelve months after inclusion.

Secondary Outcomes (1)

  • cardiovascular mortality

    six and twelve months after inclusion.

Other Outcomes (1)

  • Hospitalization for any cause

    six and twelve months after inclusion.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The elegible individuals are patients of a tertiary cardiology hospital

You may qualify if:

  • Age between 18 and 80 years old
  • Heart failure diagnosis of different etiologies
  • Left ventricular ejection fraction \< 50% in the past 2 years

You may not qualify if:

  • Patients with impaired cognition due to advanced dementia syndrome or severe psychiatric disorder
  • Patients without telephone access
  • Patients that refused to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heart Institute - Clinical Hospital - University of São Paulo Medical School

São Paulo, 050403000, Brazil

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, urine. Exhaled acethone.

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Alexandre C Pereira, MD, PhD

    Heart Institute - Clinical Hospital - University of São Paulo Medical School

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandre C Pereira, MD, PhD

CONTACT

55-11-2661-5543alexandre.pereira@incor.usp.br

Luciana Gioli-Pereira, MD, PhD

CONTACT

55-11-2661-5081lu_gioli@yahoo.com

Study Design

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

Study Record Dates

First Submitted

January 20, 2014

First Posted

January 23, 2014

Study Start

August 1, 2012

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

February 23, 2018

Record last verified: 2018-01

Locations

BR(1)