Trial Outcomes & Findings for HF Assessment With BNP in the Home: Part II (NCT NCT02351063)
NCT ID: NCT02351063
Last Updated: 2024-01-03
Results Overview
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. The primary endpoint of the study is a significant lowering of BNP across the population, such that values for the population are reduced to levels below a predetermined threshold and kept below the threshold for the duration of subsequent testing and observation.
TERMINATED
NA
1 participants
6 months
2024-01-03
Participant Flow
Participant milestones
| Measure |
Daily BNP
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.
Changes of heart failure medications: Changes in dosage of existing medications or introduction of new medications to improve heart failure condition.
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|---|---|
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Overall Study
STARTED
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1
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Overall Study
COMPLETED
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1
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
HF Assessment With BNP in the Home: Part II
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: 6 monthsPopulation: One subject enrolled but no data collected. Study terminated by sponsor.
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. The primary endpoint of the study is a significant lowering of BNP across the population, such that values for the population are reduced to levels below a predetermined threshold and kept below the threshold for the duration of subsequent testing and observation.
Outcome measures
Outcome data not reported
Adverse Events
All Subjects
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place