Screening Of Adult urBan pOpulation To diAgnose Heart Failure

NCT ID: NCT03526601

Last Updated: 2018-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

2861 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-10

Study Completion Date

2018-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Heart Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Interventions

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NT-proBNP, echocardiography

screening

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

NONE.
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Roche Pharma AG

INDUSTRY

Sponsor Role collaborator

Slovenian Research Agency

OTHER

Sponsor Role collaborator

Murska Sobota Municipiality

UNKNOWN

Sponsor Role collaborator

Community Health Center Murska Sobota

UNKNOWN

Sponsor Role collaborator

General Hospital Murska Sobota

OTHER

Sponsor Role lead

Responsible Party

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Mitja Lainscak

Professor of Internal Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mitja Lainscak, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

General Hospital Murska Sobota

Locations

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General Hospital Murska Sobota

Murska Sobota, , Slovenia

Site Status RECRUITING

Countries

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Slovenia

Central Contacts

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Mitja Lainscak, MD, PhD

Role: CONTACT

+386 2 5123 733

Facility Contacts

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Mitja Lainscak, MD, PhD

Role: primary

+386 2 5123 733

Other Identifiers

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SBMS001

Identifier Type: -

Identifier Source: org_study_id

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