HF Outpatient Monitoring Evaluation (HOME) Study

Phase 3

Completed

• Conditions: Heart Failure; decompensatio cordis; 10019280

• Registration Number: NL-OMON38287
• Lead Sponsor: Alere technologies

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

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;
OR
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
b. beta blocker
c. ACE inhibitor
3. Physical evaluation consistent with worsening HF signs (i.e. elevated JVP, ankle edema, dyspnea, abdominal distension, >4 lb or >1.8 kg weight increase in past week)
4. HF admission in last 30 days with a documented BNP > 300 pg/mL (or NT-pro-BNP > 1500 pg/mL) during or since admission
AND
e. Successfully trained and deemed proficient on how to perform a fingerstick and to use the Test System. Each subject will undergo two proficiency assessments.
i. The first assessment will be performed at the time in which the subject is found to meet the inclusion criteria, and deemed willing, able and reliable to complete the study tasks, and following initial training on the use of the test system. Successful completion of this first proficiency assessment will result in the enrolment of the subject into the study.
ii. The second assessment will be performed following one week (7 days ± 2 days) of home testing to demonstrate retention of the training. Successful completion of this second proficiency assessment will result in randomization of the subject into one of the three study arms of the study. Failure to demonstrate proficiency at this second assessment will result in the withdrawal of the subject from the study.

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;
j. Dementia, tremors or other impediments to performing daily home BNP testing via fingerstick (unless BNP testing will be conducted by qualified caregiver);
k. Deemed by the investigator not to be likely to comply with study-mandated procedures or instructions;
l. Residence in regions where either transmission of test system data or home visits are not possible.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is the average number of *hard* events per subject with<br /><br>hard events defined as any of the following occurring over 180 days:<br /><br>i. HF related death<br /><br>ii. HF related readmissions to the hospital<br /><br>iii. IV treatment with diuretics or unusual oral diuretic change in ER<br /><br>iv. Unplanned outpatient treatments for decompensated HF</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1) To determine the optimal frequency of home BNP testing and the changes in<br /><br>BNP concentrations that correlate with clinical HF decompensation and related<br /><br>adverse events in at-risk HF patients, during the early post-discharge time<br /><br>period in which patients are vulnerable to adverse events. This will be<br /><br>accomplished by analysis of patterns in daily BNP measurements observed in<br /><br>patients in whom HF decompensation occurs and in those in whom it doesn*t.<br /><br><br /><br>2) To determine the feasibility of frequent home BNP self-testing with the Test<br /><br>System in this population. This will be accomplished by completion of<br /><br>questionnaire by patients, patient feedback, and investigator experience.</p><br>