NCT03526601

Brief Summary

Screening Of adult urBan pOpulation To diAgnose Heart Failure (SOBOTA-HF) is a cross-sectional prevalence study in a representative sample of Murska Sobota residents aged 55 years or more. Individuals will be invited to participate in a screening with NT-proBNP. All subjects with NT-proBNP ≥ 125 pg/mL will be invited for a diagnostic visit that will include history and physical examination, electrocardiogram, echocardiography, ankle brachial index, pulmonary function tests, body composition measurement, physical performance tests and questionnaires. To validate the screening procedure, a control group (NT-proBNP \< 125 pg/mL) will undergo same diagnostic evaluation. An external center will validate echodardiography exams and the HF diagnosis will be adjudicated within an independent HF expert panel. Overall and age specific HF prevalence will be calculated in individuals ≥ 55 years and extrapolated to the whole population.

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
2,861

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2017

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

May 10, 2017

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

May 4, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 16, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
Last Updated

May 16, 2018

Status Verified

May 1, 2018

Enrollment Period

1.1 years

First QC Date

May 4, 2018

Last Update Submit

May 4, 2018

Conditions

Heart Failure

Keywords

heart failureprevalence

Outcome Measures

Primary Outcomes (1)

  • heart failure diagnosis as per 2016 ESC guidelines

    at diagnostic visit

Interventions

NT-proBNP, echocardiographyDIAGNOSTIC_TEST

screening

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

60% of Murska Sobota residents aged 55 years or more

You may qualify if:

  • age \>55
  • living in Murska Sobota
  • part of representative sample as selected by Statistical Office of the Republic of Slovenia

You may not qualify if:

  • NONE.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Hospital Murska Sobota

Murska Sobota, SI-9000, Slovenia

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

whole blood

MeSH Terms

Conditions

Heart Failure

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisUltrasonographyHeart Function TestsDiagnostic Techniques, Cardiovascular

Study Officials

  • Mitja Lainscak, MD, PhD

    General Hospital Murska Sobota

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mitja Lainscak, MD, PhD

CONTACT

+386 2 5123 733mitja.lainscak@guest.arnes.si

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Internal Medicine

Study Record Dates

First Submitted

May 4, 2018

First Posted

May 16, 2018

Study Start

May 10, 2017

Primary Completion

June 30, 2018

Study Completion

September 30, 2018

Last Updated

May 16, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

SL(1)