Screening Of Adult urBan pOpulation To diAgnose Heart Fai... | NCT03526601

Studies
Screening Of Adult urBan pOpulation To diAgnose Heart Failure

NCT03526601

Sponsor

General Hospital Murska Sobota

Status

Unknown status

Last Update Posted

May 16, 2018Actual

Enrollment

2,861Estimated

Phase

Not provided

Conditions

Heart Failure

Interventions

NT-proBNP, echocardiography

Countries

Slovenia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 10, 2017Actual

Primary Completion Date

Jun 30, 2018Estimated

Completion Date

Sep 30, 2018Estimated

First Submitted Date

May 4, 2018

First Submission Date that Met QC Criteria

May 4, 2018

First Posted Date

May 16, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 4, 2018

Last Update Posted Date

May 16, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mitja Lainscak, Professor of Internal Medicine, General Hospital Murska SobotaPrincipal Investigator

Lead Sponsor

General Hospital Murska SobotaOTHER

Collaborators

Name	Class
Roche Pharma AG	INDUSTRY
Slovenian Research Agency	OTHER
Murska Sobota Municipiality	UNKNOWN
Community Health Center Murska Sobota

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

2,861Estimated

Name	Type	Description	Arm Group Labels	Other Names
NT-proBNP, echocardiography	Diagnostic Test	screening

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

55 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

60% of Murska Sobota residents aged 55 years or more

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mitja Lainscak, MD, PhD	Contact	+386 2 5123 733		mitja.lainscak@guest.arnes.si

Overall Officials

Name	Affiliation	Role
Mitja Lainscak, MD, PhD	General Hospital Murska Sobota	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
General Hospital Murska Sobota	Recruiting	Murska Sobota		SI-9000	Slovenia

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006333	Heart Failure

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004452	Echocardiography

Ancestor Terms

ID	Term
D057791	Cardiac Imaging Techniques
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided