NCT02679859

Brief Summary

The primary hypothesis of the BETTER pilot trial is that B-type natriuretic peptide (BNP) directed medical therapy prior to noncardiac surgery will be associated with improved cardiovascular outcomes, when compared to standard of care.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable surgery

Timeline
Completed

Started Jul 2016

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 8, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 10, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

February 11, 2016

Status Verified

February 1, 2016

Enrollment Period

1.9 years

First QC Date

February 8, 2016

Last Update Submit

February 10, 2016

Conditions

SurgeryCardiovascular ComplicationsRisk Assessment

Keywords

Natriuretic Peptide, BrainSurgery

Outcome Measures

Primary Outcomes (1)

  • A composite of 30 day mortality, nonfatal myocardial infarction, nonfatal cardiac arrest, congestive cardiac failure and re-operation.

    30 days

Study Arms (2)

B-type natriuretic guided medical therapy optimisation

EXPERIMENTAL

B-type natriuretic guided medical therapy optimisation

Other: BNP guided medical therapy optimisation

Normal medical management

NO INTERVENTION

Interventions

BNP guided medical therapy optimisationOTHER
B-type natriuretic guided medical therapy optimisation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • High risk elective preoperative noncardiac surgical patients who are referred to a preanaesthetic clinic for preoperative risk stratification.

You may not qualify if:

  • Patient refusal to participate
  • Where clinical opinion suggests that surgery cannot be postponed for at least 3 to 4 weeks to allow for clinical response to a change in medical therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Bruce Biccard, MD, PhD

    University of Cape Town

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bruce Biccard, MD, PhD

CONTACT

bruce.biccard@uct.ac.za

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Perioperative Medicine

Study Record Dates

First Submitted

February 8, 2016

First Posted

February 10, 2016

Study Start

July 1, 2016

Primary Completion

June 1, 2018

Study Completion

July 1, 2018

Last Updated

February 11, 2016

Record last verified: 2016-02