Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2025-12-25 @ 10:51 PM
Study NCT ID:
NCT01347567
Status:
COMPLETED
Last Update Posted:
2024-01-03
First Post:
2011-05-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Heart Failure (HF) Outpatient Monitoring Evaluation (HOME) Study
Sponsor:
Alere San Diego
Organization:
Study Overview
Official Title:
HF Outpatient Monitoring Evaluation (HOME) Study
Status:
COMPLETED
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HOME
Brief Summary:
The purpose of this study is to determine if heart failure subjects whose treatment is assisted by home BNP measurements integrated into a home health management system will have better clinical outcomes than subjects whose treatment includes home health management without BNP or than subjects treated by standard care.
Detailed Description:
Systolic dysfunction heart failure subjects with low ejection fraction and elevated BNP levels admitted to hospital or treated as outpatient for decompensated Heart Failure (HF) are at hight risk for recurrent decompensation and readmission. The objective of this study is to investigate if these patients may benefit from enhanced home monitoring of their HF status.
In the 3 study arms (BNP, Health Management and control groups) home fingerstick BNP levels will be obtained so that frequent data points are available for analysis of trends and variability. These results will remain blinded to the subjects in all study arms and their care providers in the health management and control arms, the investigator and staff will have access to the BNP results only for subjects in the BNP arm and will use this information to aid in therapy decisions.
Subjects are monitored for 180 days as this time period is likely sufficient to differentiate normal biological variation in BNP changes due to impending decompensation.
Patients will be assessed at Day 30,90 and 180 after randomization HF status, patient clinical outcome and treatment adjustments are recorded.
Follow-up telephone calls to subjects at 3 and 6 months after completion of home testing will be conducted in order to determine the possible long-term benefit of home health management with daily BNP testing.
In the 3 study arms (BNP, Health Management and control groups) home fingerstick BNP levels will be obtained so that frequent data points are available for analysis of trends and variability. These results will remain blinded to the subjects in all study arms and their care providers in the health management and control arms, the investigator and staff will have access to the BNP results only for subjects in the BNP arm and will use this information to aid in therapy decisions.
Subjects are monitored for 180 days as this time period is likely sufficient to differentiate normal biological variation in BNP changes due to impending decompensation.
Patients will be assessed at Day 30,90 and 180 after randomization HF status, patient clinical outcome and treatment adjustments are recorded.
Follow-up telephone calls to subjects at 3 and 6 months after completion of home testing will be conducted in order to determine the possible long-term benefit of home health management with daily BNP testing.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: