NCT01347567

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

HF Outpatient Monitoring Evaluation (HOME) Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 145 (actual)
• Sponsor: Alere San Diego · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Failure
• Systolic Heart Failure
• Acute Decompensated Heart Failure

Interventions

Type	Name	Description
OTHER	Interventions with heart failure medications	Therapeutic interventions with heart failure medications per decision of treating physician for subjects in all study arms but using the different information available in each study arm.

Timeline

• Start date: 2011-04-01
• Primary completion: 2013-03-01
• Completion: 2014-01-01
• First posted: 2011-05-04
• Last updated: 2024-01-03

Locations

7 sites across 6 countries: Australia, Ireland, Netherlands, New Zealand, Sweden, United Kingdom