The Influence of NPPA/NPPB Haplotype on Natriuretic Pepti... | NCT04327258

Studies
The Influence of NPPA/NPPB Haplotype on Natriuretic Peptide Plasma Levels

NCT04327258

Sponsor

Insel Gruppe AG, University Hospital Bern

Status

Completed

Last Update Posted

Mar 31, 2020Actual

Enrollment

437Actual

Phase

Not provided

Conditions

Anesthesia
Surgical Procedure, Operative

Interventions

Not provided

Countries

Switzerland

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

Mar 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2011

Primary Completion Date

Dec 2014Actual

Completion Date

Dec 2014Actual

First Submitted Date

Mar 26, 2020

First Submission Date that Met QC Criteria

Mar 26, 2020

First Posted Date

Mar 31, 2020Actual

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

Mar 26, 2020

Last Update Posted Date

Mar 31, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Crosssectional study to analyse the genetic influence on levels of cardiac biomarkers (BNP, NT-proBNP).

Detailed Description

Background

Natriuretic peptides play an important role in risk stratification and management of patients undergoing non-cardiac surgery. However, due to genetic variability, the levels of these biomarkers may differ in individual patients with cardiac derangement. In the preoperative setting, genetic contribution to natriuretic peptide plasma level variability has not yet been determined.

Objective

The aim of this study is to assess genetic contribution to NP plasma level variability in a Swiss cohort.

Methods

Cross-sectional association study in a cohort of non-cardiac surgery patients.

This study is a Subproject of a prospective cohort study registered under the ID 041/09.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

437Actual

Label	Type	Description	Intervention Names
All patients		Patients undergoing elective surgery with anesthesia

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Influence of NPPA/NPPB haplotype on natriuretic peptide plasma levels	Estimation of genetic effects on natriuretic peptide (BNP, NT-proBNP) plasma levels	Blood samples collected at start of anesthetic procedure

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 years and older
Written informed consent
Scheduled surgery

Exclusion Criteria

No informed consent
Cognitive impairment

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients scheduled for elective surgery

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Frank Stüber, Prof. MD	Department of Anaesthesiology and Pain Medicine, Inselspital, University of Bern	Study Chair
Ulrike M Stamer, MD	Department of Anaesthesiology and Pain Medicine, Inselspital, University of Bern	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Anaesthesiology and Pain Medicine, Inselspital, University of Bern		Bern		3010	Switzerland