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Heart Failure (HF) Outpatient Monitoring Evaluation (HOME) Study — HOME  

Heart Failure Clinical Trial

Official title:
HF Outpatient Monitoring Evaluation (HOME) Study

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01347567
Study type Interventional
Source Abbott RDx Cardiometabolic
Contact
Status Completed
Phase N/A
Start date April 2011
Completion date January 2014
View Details
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