NL-OMON38287
Completed
Phase 3
HF Outpatient Monitoring Evaluation (HOME) Study - HOME
Alere technologies0 sites30 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- Alere technologies
- Enrollment
- 30
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •a. Consenting Adults at least 18 years of age
- •b. Prior or concurrent diagnosis of HF with LVSD (LVEF\<\=40%);
- •c. Deemed suitable for participation in this study;
- •Note: Home Health Management and therapy guided by the results of home testing are not appropriate for every patient. All potential subjects should be evaluated and deemed suitable for participation in this home health management study on the bases of their anticipated ability to understand and perform the daily testing activities, the likelihood of compliance, and the expectation that guided therapy would have a benefit to the patient. Special attention should be given when evaluating patients who are \>\= 75 years of age. ;
- •d. Meets on of the criteria below:
- •i. Enrolled within 30 days of an ADHF event where at least one BNP value during the hospital admission or clinic visit was \> 300 pg/mL (or NT\-pro\-BNP \> 1500 pg/mL) and there is an intent to treat for heart failure;
- •ii. Seen in an outpatient setting (i.e. heart failure clinic, general practice or cardiology office, urgent care unit) with a documented history of HF and with signs of worsening HF condition or decompensation, where worsening HF condition is defined as one or more of the following;
- •1\. Increase in NYHA class with worsening symptoms (i.e. dyspnea, fatigue) at same level of activity
- •2\. Symptoms requiring change in dosage of one or more of the following medications:
- •a. diuretic
Exclusion Criteria
- •a. Unwilling or unable to provide written informed consent;
- •b. Acute coronary syndrome (ACS) that is a primary diagnosis; or secondary diagnosis that is concomitant with the primary diagnosis of decompensated HF and for which treatment will be provided.
- •Note: A history of ACS is not cause for exclusion if it is not concomitant with the present decompensated HF for which admission is being made. Small elevations in cardiac troponin that are considered by the treating physician to be associated with myocardial injury due to the acute decompensated HF and not due to a concomitant ACS or myocardial infarction are not a basis for exclusion.
- •c. Previous cardiac transplantation \- or cardiac transplantation anticipated within 3 months;
- •d. Current or planned use of a left ventricular assist device (LVAD), use of outpatient intravenous inotropic HF therapy, major surgical procedure or percutaneous coronary intervention within 3 months;
- •e. Life expectancy less than 6 months due to causes other than HF or cardiovascular disease (e.g., cancer);
- •f. End stage renal disease (dialysis dependency);
- •g. Receiving any investigational medication;
- •h. Hematocrit outside the 25 to 50% range of the HeartCheck system;
- •i. Prisoner or other institutionalized or vulnerable individual;
Outcomes
Primary Outcomes
Not specified
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