Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT07160829




Registration number
NCT07160829
Ethics application status
Date submitted
29/08/2025
Date registered
8/09/2025
Date last updated
8/09/2025

Titles & IDs
Public title
Focus on Levels of Awareness and Perceptions Regarding hsCRP in Identifying Systemic Inflammation in ASCVD, CKD and Heart Failure Management
Scientific title
Focus on Levels of Awareness and Perceptions Regarding hsCRP in Identifying Systemic Inflammation in ASCVD, CKD and Heart Failure Management
Secondary ID [1] 0 0
U1111-1315-0755
Secondary ID [2] 0 0
DAS-8416
Universal Trial Number (UTN)
Trial acronym
FLARE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atherosclerotic Cardiovascular Disease 0 0
Heart Failure 0 0
Chronic Kidney Disease 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - No treatment given

Nephrologist Group - This group includes nephrologists treating people with ASCVD and CKD.

Cardiologist Group - This group includes cardiologist treating people with ASCVD and CKD.


Other interventions: No treatment given
No treatment given
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Perceptions towards role of systemic inflammation in identification, treatment, management of ASCVD+CKD and HF
Timepoint [1] 0 0
At the time of survey response (Day 1)

Eligibility
Key inclusion criteria
* Informed consent obtained before any study related activities (study-related activities are any procedure related to recording of data according to the protocol).
* Male or female, age above 18 years at the time of signing informed consent.
* Is a nephrologist or cardiologist. Cardiologists may be a mix of Interventional Cardiology, Heart Failure (HF) Specialist, General Cardiology, Preventative Cardiology, Cardiac Electrophysiology, Cardio-Oncology or Echocardiography (India only).
* Has been in specialty practice greater than or equal to 3 years.
* If cardiologist, sees at least 15 people with Atherosclerotic Cardiovascular Disease (ASCVD) with or without Chronic Kidney Disease (CKD) per month.
* If nephrologist, sees at least 20 people with ASCVD and CKD per month.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Previous participation in this study. Participation is defined as having given informed consent in this study.
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
* If nephrologist, is only using dialysis to treat people with ASCVD and CKD.
* Does not meet inclusion criteria requirements.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/09/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/10/2025
Actual
Sample size
Target
608
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Novo Nordisk Investigational Site - Sydney
Recruitment postcode(s) [1] 0 0
2060 - Sydney
Recruitment outside Australia
Country [1] 0 0
India
State/province [1] 0 0
Karnataka
Country [2] 0 0
South Korea
State/province [2] 0 0
Seoul
Country [3] 0 0
Thailand
State/province [3] 0 0
Bangkok

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novo Nordisk A/S
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Transparency dept. 2834
Address 0 0
Novo Nordisk A/S
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Novo Nordisk
Address 0 0
Country 0 0
Phone 0 0
(+1) 866-867-7178
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://novonordisk-trials.com


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT07160829