Clinical trial NCT02351063
Conditions: Heart Failure
Keywords: Heart failure BNP home testing remote monitoring
Sponsor: Alere San Diego
Start date: 2014-04-01; Completion date: 2014-07-01
Enrollment: 1 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
HABIT-II is a feasibility study aimed at home monitoring of patients with heart failure. B-type natriuretic peptide (BNP) has strong correlations to the severity of heart failure. Lower BNP levels are closely associated with better clinical outcomes. The goal of HABIT-II is to demonstrate that the results of daily patient self-testing of BNP at home will provide sufficient information to guide physicians to modify therapy and lower BNP levels over time.

Detailed description:
This is a single arm multi-center pilot study. Subjects with heart failure (HF) who are discharged following an acute decompensated heart failure (ADHF) event and subjects who are seen as outpatients with worsening signs or symptoms of HF, who meet enrollment criteria, are candidates for this study. Subjects with HF with reduced left ventricular ejection fraction (HFREF) and subjects with HF with preserved ejection fraction (HFPEF) are eligible. The eventual objective of this area of research is to demonstrate that HF subjects assisted by frequent B-type natriuretic peptide (BNP) measurements integrated into a home health management system have improved clinical outcomes. The specific objective of this study is to demonstrate that frequent BNP measurements integrated into a home health management system used by physicians to modify or intensify therapy will lead to a reduced risk of ADHF events as measured by a reduction in BNP levels. Subjects will be asked to test their BNP at home every day for a period of 180 days using the AlereTM HeartCheck System (the Test System). In addition to BNP, weights and signs and symptoms of HF will be collected each day of testing. The HeartCheck data is transmitted via a secure wireless protocol to the HealthCOM health monitoring portal where it is available to the medical staff.

Enrollment goal is 110 evaluable subjects. Potential subjects who meet the study's inclusion and exclusion criteria will be interviewed about their interest in participating in the study. Potential subjects that show interest in the study will be judged for their willingness, ability and reliability to perform fingerstick BNP measurements every day for 180 days while at home and be able to report the results using the HeartCheck system. All qualifying subjects who agree to participate and provide Informed Consent will be trained to use the HeartCheck system which includes daily BNP measurements, daily body weight measurements, and daily health survey questions. Subjects who successfully complete their training will be judged on their proficiency in all study activities. If found to be proficient; they will use the system at home. After a short lead-in period, an algorithm (similar in concept to a moving average) will be applied to the BNP data resulting in a BNP-based parameter and alerts will be created when this parameter is rising, or during periods of sustained high BNP. The patient's physician and medical staff will be required to evaluate all BNP based alert notifications and determine if a change in HF treatment is advisable. All changes in HF treatment, with or without BNP-based alerts, are at the discretion of the treating physician and medical staff of the institution.

The primary endpoint of the study is a significant lowering of BNP across the population. At approximately 1, 3 and 6 months after enrollment, subjects will return to the clinic for physical examination, clinical assessment, and review of interval medical status by their health care provider. In addition, if warranted, a home health care professional may visit the subject at home at any time during the study when additional counseling or training may be of benefit for compliance to the protocol.

Arms: arm 1: Subjects will be asked to test their BNP at home every day for a period of 180 days using the AlereTM HeartCheck System (the Test System). In addition to BNP, weights and signs and symptoms of HF will be collected each day of testing. The HeartCheck data is transmitted via a secure wireless protocol to the HealthCOM health monitoring portal where it is available to the medical staff. The subject's's physician and medical staff will be required to evaluate the data and determine if a change in HF treatment is advisable. All changes of heart failure medications are at the discretion of the treating physician and medical staff of the institution.
Interventions: intervention 1: Changes of heart failure medications
Intervention descriptions: intervention 1: Changes in dosage of existing medications or introduction of new medications to improve heart failure condition.

Protocol documents: