Screening Of Adult urBan pOpulation To diAgnose Heart Failure (SOBOTA-HF)

May 4, 2018 updated by: Mitja Lainscak, General Hospital Murska Sobota
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

2861

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovenia
      • Murska Sobota, Slovenia, SI-9000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

60% of Murska Sobota residents aged 55 years or more

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
heart failure diagnosis as per 2016 ESC guidelines
Time Frame: at diagnostic visit
at diagnostic visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

General Hospital Murska Sobota

Collaborators

Roche Pharma AG
Slovenian Research Agency
Murska Sobota Municipiality
Community Health Center Murska Sobota

Investigators

  • Principal Investigator: Mitja Lainscak, MD, PhD, General Hospital Murska Sobota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 10, 2017

Primary Completion (Anticipated)

June 30, 2018

Study Completion (Anticipated)

September 30, 2018

Study Registration Dates

First Submitted

May 4, 2018

First Submitted That Met QC Criteria

May 4, 2018

First Posted (Actual)

May 16, 2018

Study Record Updates

Last Update Posted (Actual)

May 16, 2018

Last Update Submitted That Met QC Criteria

May 4, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SBMS001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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