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

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ClinicalTrials.gov Identifier: NCT03526601
Recruitment Status : Recruiting
First Posted : May 16, 2018
Last Update Posted : May 16, 2018
Sponsor:
Collaborators:
Roche Pharma AG
Slovenian Research Agency
Murska Sobota Municipiality
Community Health Center Murska Sobota
Information provided by (Responsible Party):
Mitja Lainscak, General Hospital Murska Sobota

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.

Condition or disease Intervention/treatment
Heart Failure Diagnostic Test: NT-proBNP, echocardiography

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 2861 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 5 Years
Official Title: Screening Of Adult urBan pOpulation To diAgnose Heart Failure
Actual Study Start Date : May 10, 2017
Estimated Primary Completion Date : June 30, 2018
Estimated Study Completion Date : September 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure


Intervention Details:
  • Diagnostic Test: NT-proBNP, echocardiography
    screening


Primary Outcome Measures :
  1. heart failure diagnosis as per 2016 ESC guidelines [ Time Frame: at diagnostic visit ]

Biospecimen Retention:   Samples With DNA
whole blood


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
60% of Murska Sobota residents aged 55 years or more
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03526601


Contacts
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Contact: Mitja Lainscak, MD, PhD +386 2 5123 733 mitja.lainscak@guest.arnes.si

Locations
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Slovenia
General Hospital Murska Sobota Recruiting
Murska Sobota, Slovenia, SI-9000
Contact: Mitja Lainscak, MD, PhD    +386 2 5123 733    mitja.lainscak@guest.arnes.si   
Sponsors and Collaborators
General Hospital Murska Sobota
Roche Pharma AG
Slovenian Research Agency
Murska Sobota Municipiality
Community Health Center Murska Sobota
Investigators
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Principal Investigator: Mitja Lainscak, MD, PhD General Hospital Murska Sobota

Additional Information:

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Responsible Party: Mitja Lainscak, Professor of Internal Medicine, General Hospital Murska Sobota
ClinicalTrials.gov Identifier: NCT03526601     History of Changes
Other Study ID Numbers: SBMS001
First Posted: May 16, 2018    Key Record Dates
Last Update Posted: May 16, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mitja Lainscak, General Hospital Murska Sobota:
heart failure
prevalence
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases