AnesthesiaNCT04327258
The Influence of NPPA/NPPB Haplotype on Natriuretic Peptide Plasma Levels
An observational study of Anesthesia and Surgical Procedure, Operative, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
Crosssectional study to analyse the genetic influence on levels of cardiac biomarkers (BNP, NT-proBNP). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Surgical Procedure, Operative
- How many people
- 437 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2011to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients scheduled for elective surgery
Who may be able to join
- 18 years and older
- Written informed consent
- Scheduled surgery
Who cannot join
- No informed consent
- Cognitive impairment
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Anaesthesiology and Pain Medicine, Inselspital, University of Bern
Bern, 3010
About this study
Crosssectional study to analyse the genetic influence on levels of cardiac biomarkers (BNP, NT-proBNP).
Read the 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.
- Conditions
- Anesthesia, Surgical Procedure, Operative
- Keywords
- genetic association study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| All patients | Patients undergoing elective surgery with anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Influence of NPPA/NPPB haplotype on natriuretic peptide plasma levels
Estimation of genetic effects on natriuretic peptide (BNP, NT-proBNP) plasma levels
Measured: Blood samples collected at start of anesthetic procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2020
- Study startJan 2011
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 437 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frank Stüber, Prof. MD, Study chair, Department of Anaesthesiology and Pain Medicine, Inselspital, University of BernUlrike M Stamer, MD, Principal investigator, Department of Anaesthesiology and Pain Medicine, Inselspital, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04327258
- Sponsor's protocol ID
- 041/09e
- Status last verified
- Mar 2020
- First submitted
- 26 Mar 2020
- Last updated
- 31 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of NPPA/NPPB Haplotype on Natriuretic Peptide Plasma Levels
- ClinicalTrials.gov ID
- NCT04327258
- Acronym / sponsor ID
- 041/09e
- Conditions
- Anesthesia, Surgical Procedure, Operative
- Keywords
- genetic association study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 437 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 31 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients | – | –Patients undergoing elective surgery with anesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for elective surgery
Key inclusion criteria (3 listed)
- 18 years and older
- Written informed consent
- Scheduled surgery
Key exclusion criteria (2 listed)
- No informed consent
- Cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Influence of NPPA/NPPB haplotype on natriuretic peptide plasma levels
Time frame: Blood samples collected at start of anesthetic procedure
Estimation of genetic effects on natriuretic peptide (BNP, NT-proBNP) plasma levels
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank Stüber, Prof. MD study chair
Department of Anaesthesiology and Pain Medicine, Inselspital, University of Bern
Ulrike M Stamer, MD principal investigator
Department of Anaesthesiology and Pain Medicine, Inselspital, University of Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia and Surgical Procedure, Operative, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Influence of NPPA/NPPB haplotype on natriuretic peptide plasma levels (time frame: Blood samples collected at start of anesthetic procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2020.