Screening Of Adult urBan pOpulation To diAgnose Heart Failure

Heart Failure Clinical Trial

— SOBOTA-HF  

Official title:

Screening Of Adult urBan pOpulation To diAgnose Heart Failure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03526601
• Other study ID #: SBMS001
• Status: Recruiting
• Start date: May 10, 2017
• Est. completion date: September 30, 2018

Study information

• Verified date: May 2018
• Source: General Hospital Murska Sobota
• Contact: Mitja Lainscak, MD, PhD
• Phone: +386 2 5123 733
• Email: mitja.lainscak[@]guest.arnes.si
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2861
• Est. completion date: September 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years and older

Eligibility

Inclusion Criteria:

• age >55

• living in Murska Sobota

• part of representative sample as selected by Statistical Office of the Republic of Slovenia

Exclusion Criteria:

Related Conditions & MeSH terms

• Heart Failure

Intervention

Diagnostic Test:
• NT-proBNP, echocardiography
screening

Locations

Country	Name	City	State
Slovenia	General Hospital Murska Sobota	Murska Sobota

Sponsors (5)

Lead Sponsor	Collaborator
General Hospital Murska Sobota	Community Health Center Murska Sobota, Murska Sobota Municipiality, Roche Pharma AG, Slovenian Research Agency

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	heart failure diagnosis as per 2016 ESC guidelines		at diagnostic visit