NCT03300791

Brief Summary

This is a prospective nested case-control study. Our goals are to create predictive models to readmissions for heart failure and also to define profiles for patients who are readmitted during the first month after the index episode. Patients who will be admitted in five hospitals in spain by the reason of a heart failure will be recruited during 18 months. Those who will be readmitted in a hospital up to a month after the index episode will be considered cases. Controls will be selected from the initial cohort of hospitalized patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2017

Typical duration for all trials

Geographic Reach
1 country

4 active sites

Status
completed

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

First Submitted

Initial submission to the registry

September 26, 2017

Completed
2 days until next milestone

Study Start

First participant enrolled

September 28, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 3, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

September 29, 2021

Status Verified

September 1, 2021

Enrollment Period

1.3 years

First QC Date

September 26, 2017

Last Update Submit

September 28, 2021

Conditions

Keywords

heart failurereadmissionpredictive models

Outcome Measures

Primary Outcomes (1)

  • Readmission

    Up to a month after admission by heart failure

    1 month

Secondary Outcomes (1)

  • Readmission

    12 months

Study Arms (1)

Admitted

We will include patients who had beeb admitted by an acute heart failure in hospitalization ward

Other: Admitted

Interventions

Readmitted patients in the next months after an episode of aute heart failure will be recruited. Controls will be selected between those who were admitted in the baseline but not readmitted in this month.

Also known as: Not readmitted
Admitted

Eligibility Criteria

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

Patients admitted by the reason of heart failure

You may qualify if:

  • Patients admitted by acute heart failure (de novo and acute decompensated) (International Classification of Diseases, Ninth Revision, Clinical Modification: 428.x; some of the 402.x group), older tan 18 who will accept to participate.

You may not qualify if:

  • patients who develop HF episodes during admission, if have been admitted for another reason,
  • patients transferred from other health centers,
  • myocardial infarction or stroke in the 4 weeks prior to admission,
  • life expectancy less than one year, for HF at the terminal or cause different from the CI according to the assessment of the study subjects,
  • inability to complete the questionnaires or with assistance external (reviewer, family, social) because of sensorineural reason, dementia or ignorance of the language.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Marisa Bare

Sabadell, Barcelona, 08208, Spain

Location

Ainara

Bilbao, Bizkaia, 48013, Spain

Location

Irene Rilo

Donostia / San Sebastian, Gipuzkoa, 20014, Spain

Location

Raul

Marbella, Málaga, 29600, Spain

Location

Related Publications (1)

  • Garcia-Gutierrez S, Villanueva A, Lafuente I, Rodriguez I, Lozano-Bahamonde A, Murga N, Orus J, Camacho ER, Quintana JM, Quiros R; ReIC-REDISSEC working group. Factors related to early readmissions after acute heart failure: a nested case-control study. BMC Cardiovasc Disord. 2023 Jan 12;23(1):17. doi: 10.1186/s12872-022-03029-2.

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Susana Garcia-Gutierrez, PhD

    Unidad de Investigación. Hospital Galdakao-Usansolo. Osakidetza

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

September 26, 2017

First Posted

October 3, 2017

Study Start

September 28, 2017

Primary Completion

February 1, 2019

Study Completion

December 31, 2020

Last Updated

September 29, 2021

Record last verified: 2021-09

Locations