Screening Evaluation of the Evolution of New Heart Failure (SCREEN-HF)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
HBA
Information provided by (Responsible Party):
Henry Krum, The Alfred
ClinicalTrials.gov Identifier:
NCT00400257
First received: November 15, 2006
Last updated: May 29, 2013
Last verified: May 2013
  Purpose

The investigators are hoping to identify early heart failure in patients who do not have symptoms as yet and at the same time assess the usefulness of Brain natriuretic peptide (BNP) in doing this.


Condition Intervention
Heart Failure
Behavioral: Early detection of heart failure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: SCREEN-HF (Screening Evaluation of the Evolution of New Heart Failure)

Resource links provided by NLM:


Further study details as provided by The Alfred:

Primary Outcome Measures:
  • To assess the effectiveness of BNP in determining Heart Failure in people not previously diagnosed with the condition. [ Time Frame: at visit 2 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Blood samples


Estimated Enrollment: 3500
Study Start Date: May 2007
Estimated Study Completion Date: December 2014
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
People at high risk of heart failure.
Behavioral: Early detection of heart failure
Early detection of heart failure

Detailed Description:

Measuring Brain natriuretic peptide (BNP) and N-terminal proBNP (NT-proBNP)and can give us useful information about a persons heart function in patients with symptoms such as shortness of breath. This is because BNP/NT-proBNP levels rise when the heart is under pressure as it is in people with heart disease. However, we don't know if this is a useful test to do in people who are at a high risk of developing heart disease but who have no symptoms and have not been diagnosed with any heart problems.

In this study we hope to recruit 3500 participants. This study is being run in conjunction with HBA (recently renamed Bupa) and we estimate that 10,000 HBA members will need to be contacted by letter and invited to screen for this study to achieve the required 3500 (protocol amended to include people who meet the entry criteria but who are not insured through HBA).

This protocol has been amended to allow us to invite 50 participants with the lowest NT-proBNP levels to also continue in the study and have blood tests, an ECG and echocardiography as described below.

Participants will undergo a routine blood test which will include measuring NT-proBNP. Only participants in whom NT-proBNP is elevated will undergo additional blood tests (for cardiac markers), an ECG and echocardiography to determine if there is any indication that they do have heart disease even though they have not been diagnosed and are not symptomatic.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

People at high risk of heart failure.

Criteria

Inclusion Criteria:

  1. Age ≥60 years
  2. Have been insured with HBA for 12 months or longer (Protocol amended to remove this criteria and allow enrollment of the general public)
  3. 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 ischemic heart disease
    • Prior Cerebrovascular Accident (CVA)
    • Known valvular heart disease without known LV dysfunction
    • Atrial fibrillation
    • Ventricular arrhythmia resulting in syncope or pre-syncope (protocol amended to remove this entry criteria)
    • Treated hypertension, of at least 2 years duration
    • Treated Diabetes mellitus, of at least 2 years duration
    • Estimated Glomerular Filtration Rate (eGFR) <50ml/min

Exclusion Criteria:

  1. Known systolic or diastolic heart failure
  2. Symptoms suggestive of current heart failure. (protocol amended to remove this criteria)
  3. LV systolic or diastolic dysfunction on echocardiography or other objective imaging modality.
  4. Medications for treatment of heart failure such as ACE inhibitors, angiotensin receptor blockers (ARBs), beta-blockers or aldosterone antagonists. Use of such medications for approved indications such as hypertension, post-MI management (without known LV dysfunction) or for diabetic nephropathy is permitted. (protocol amended to remove this criteria)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00400257

Locations
Australia, Victoria
Alfred Hospital
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
Henry Krum
HBA
Investigators
Principal Investigator: Henry Krum, Professor Monash University / Alfred Hospital
  More Information

No publications provided

Responsible Party: Henry Krum, Prof Henry Krum, The Alfred
ClinicalTrials.gov Identifier: NCT00400257     History of Changes
Other Study ID Numbers: CP-04/06
Study First Received: November 15, 2006
Last Updated: May 29, 2013
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by The Alfred:
Heart Failure
BNP

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 23, 2014