- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03526601
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
-
-
-
Murska Sobota, Slovenia, SI-9000
- Recruiting
- General Hospital Murska Sobota
-
Contact:
- Mitja Lainscak, MD, PhD
- Phone Number: +386 2 5123 733
- Email: mitja.lainscak@guest.arnes.si
-
-
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
Collaborators
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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