SCREEN-HFL (SCReening Evaluation of the Evolution of New... | NCT01581827

Studies
SCREEN-HFL (SCReening Evaluation of the Evolution of New Heart Failure) - a Longitudinal Study

NCT01581827

Sponsor

Monash University

Status

Completed

Last Update Posted

Apr 9, 2018Actual

Enrollment

3,000Actual

Phase

Not provided

Conditions

Heart Failure

Interventions

Not provided

Countries

Australia

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

Apr 2018

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 2009

Primary Completion Date

Dec 2015Actual

Completion Date

Dec 2017Actual

First Submitted Date

Apr 12, 2012

First Submission Date that Met QC Criteria

Apr 18, 2012

First Posted Date

Apr 20, 2012Estimated

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

Apr 5, 2018

Last Update Posted Date

Apr 9, 2018Actual

Name	Class
National Health and Medical Research Council, Australia	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

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

Heart failure (when the heart does not pump as well as it used to) is a medical condition which reduces the quality of life for the sufferers. Approximately 10% of people in western societies aged over 75 develop heart failure. There has been a shift towards prevention of this disease and it is hoped that BNP (brain natriuretic peptides) and NT-proBNP (N-terminal proBNP) will prove to be useful indicators of those at greatest risk. The current study therefore plans to follow up the 3500 participants at risk of heart failure from the original SCREEN-HF study.

Participants who are willing to participate will be contacted annually. They will undergo a short physical exam, will be asked to complete a Quality of Life questionnaire and will have a blood sample taken. At the end of the study participants will also have an ECG and an echocardiogram.

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

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

3,000Actual

Label	Type	Description	Intervention Names
Study population		People at high risk of heart failure (from SCREEN-HF study)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in NT-proBNP		baseline and 5 years
Change in echocardiogram		baseline and 5 years

Secondary Outcomes

Measure	Description	Time Frame
incidence of new heart failure		baseline and 5 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Consented and enrolled in the SCREEN-HF study and who agreed to further contact
Age ≥ 60 years
Subjects at high-risk of subsequent development of heart failure; comprising at least one of:
- Prior myocardial infarction (MI) without known left ventricular (LV) dysfunction
- Current active ischaemic heart disease
- Prior Cerebrovascular Accident (CVA)
- Known valvular heart disease without known LV dysfunction
- Atrial fibrillation
- Treated hypertension, of at least 2 years duration
- Treated Diabetes mellitus, of at least 2 years duration
- Chronic renal impairment (eGFR < 60 ml/min)

Exclusion Criteria:

Known systolic or diastolic heart failure
LV systolic or diastolic dysfunction on echocardiography or other objective imaging modality (if known).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

People at high risk of heart failure

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Henry Krum, MBBS FRACP PhD	Monash University/Alfred Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Monash University		Caulfield	Victoria	3162	Australia

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33902478	Derived	Campbell DJ, Coller JM, Gong FF, McGrady M, Boffa U, Shiel L, Liew D, Stewart S, Owen AJ, Krum H, Reid CM, Prior DL. Kidney age - chronological age difference (KCD) score provides an age-adapted measure of kidney function. BMC Nephrol. 2021 Apr 26;22(1):152. doi: 10.1186/s12882-021-02324-y.
30057766	Derived

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases