Trial Outcomes & Findings for Feasibility of an Integrated Patient Care (IPC) System Using Daily Filling Pressures (NCT NCT01370564)
NCT ID: NCT01370564
Last Updated: 2018-07-11
Results Overview
The proportion of study days a PtIS is based on the subjects' daily pressure state
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
21 participants
Primary outcome timeframe
Baseline through Completion/Exit (an average of 3 months)
Results posted on
2018-07-11
Participant Flow
Participant milestones
| Measure |
Daily Diuretic Adjustment
Daily adjustments of diuretics and associated supplements based on cardiac filling pressures.
Diuretics: Daily adjustments of diuretics and associated supplements based on cardiac filling pressures.
|
|---|---|
|
Overall Study
STARTED
|
21
|
|
Overall Study
COMPLETED
|
21
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Feasibility of an Integrated Patient Care (IPC) System Using Daily Filling Pressures
Baseline characteristics by cohort
| Measure |
Daily Diuretic Adjustment
n=21 Participants
Daily adjustments of diuretics and associated supplements based on cardiac filling pressures.
Diuretics: Daily adjustments of diuretics and associated supplements based on cardiac filling pressures.
|
|---|---|
|
Age, Continuous
|
59.2 years
STANDARD_DEVIATION 12.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=5 Participants
|
|
New York Heart Association Classification
Class I
|
4 Participants
n=5 Participants
|
|
New York Heart Association Classification
Class II
|
12 Participants
n=5 Participants
|
|
New York Heart Association Classification
Class III
|
5 Participants
n=5 Participants
|
|
New York Heart Association Classification
Class IV
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline through Completion/Exit (an average of 3 months)Population: The analysis population is the total number of study participants. For each study subject, the number of days in which the IPC system delivered a patient instruction set based on the subject's pressure state as measured by the Chronicle ICD/IHM pressure sensor.
The proportion of study days a PtIS is based on the subjects' daily pressure state
Outcome measures
| Measure |
Daily Diuretic Adjustment
n=1586 Days
Daily adjustments of diuretics and associated supplements based on cardiac filling pressures.
Diuretics: Daily adjustments of diuretics and associated supplements based on cardiac filling pressures.
|
|---|---|
|
Characterize the Technical Feasibility of the Network Based IPC System
|
72 percentage of days
Interval 65.0 to 78.0
|
SECONDARY outcome
Timeframe: Baseline through Completion/Exit (an average of 3-months)Population: The analysis population is the total number of study participants. For each study subject, the number of changes to the IPC setup were obtained
The frequency of changes in the IPC setup during the study (an average of 3-months).
Outcome measures
| Measure |
Daily Diuretic Adjustment
n=21 Participants
Daily adjustments of diuretics and associated supplements based on cardiac filling pressures.
Diuretics: Daily adjustments of diuretics and associated supplements based on cardiac filling pressures.
|
|---|---|
|
Characterize the Rate of IPC Setup System Changes
|
0.2 changes per day
Interval 0.1 to 0.4
|
SECONDARY outcome
Timeframe: Baseline through Completion/Exit (on average 3-months)Population: The analysis population is the total number of study participants. For each study subject, the number of days in which the subject indicated that they followed their PtIS
The proporition of IPC days study subjects indicated they complied with their PtIS.
Outcome measures
| Measure |
Daily Diuretic Adjustment
n=21 Participants
Daily adjustments of diuretics and associated supplements based on cardiac filling pressures.
Diuretics: Daily adjustments of diuretics and associated supplements based on cardiac filling pressures.
|
|---|---|
|
Quantify Subject Compliance to Daily PtIS
|
0.994 proportion of compliant days
Interval 0.988 to 1.0
|
SECONDARY outcome
Timeframe: Baseline through Completion/Exit (an average of 3-months)Population: Subjects with brain natriuretic peptide values at baseline and study completion (3-month visit) visits
Changes in brain natriuretic peptide from baseline to study exit (an average of 3-months).
Outcome measures
| Measure |
Daily Diuretic Adjustment
n=21 Participants
Daily adjustments of diuretics and associated supplements based on cardiac filling pressures.
Diuretics: Daily adjustments of diuretics and associated supplements based on cardiac filling pressures.
|
|---|---|
|
Estimate Changes in Clinical Markers of Heart Failure and Kidney Function
|
-44.4 pg/dL
Standard Deviation 388.8
|
SECONDARY outcome
Timeframe: Baseline through Completion/Exit (an average of 3-months)Population: All 21 subjects participating in the IPC study
All serious adverse events, cardiovascular adverse events, and event related to the IPC system will be documented and summarized.
Outcome measures
| Measure |
Daily Diuretic Adjustment
n=21 Participants
Daily adjustments of diuretics and associated supplements based on cardiac filling pressures.
Diuretics: Daily adjustments of diuretics and associated supplements based on cardiac filling pressures.
|
|---|---|
|
Summarize Adverse Events
Heart Failure Related Adverse Event · No
|
19 Participants
|
|
Summarize Adverse Events
Cardiovascular Related Adverse Event · Yes
|
3 Participants
|
|
Summarize Adverse Events
Cardiovascular Related Adverse Event · No
|
18 Participants
|
|
Summarize Adverse Events
IPC Related Adverse Events · Yes
|
0 Participants
|
|
Summarize Adverse Events
IPC Related Adverse Events · No
|
21 Participants
|
|
Summarize Adverse Events
PtIS Related Adverse Events · Yes
|
0 Participants
|
|
Summarize Adverse Events
PtIS Related Adverse Events · No
|
21 Participants
|
|
Summarize Adverse Events
Heart Failure Related Adverse Event · Yes
|
2 Participants
|
|
Summarize Adverse Events
Serious Adverse Event · Yes
|
2 Participants
|
|
Summarize Adverse Events
Serious Adverse Event · No
|
19 Participants
|
SECONDARY outcome
Timeframe: Baseline through Completion/Exit (an average of 3-months)Population: Subjects with lestimated glomular filtration rate values available at the baseline and study exit (3-month) visit.
Changes in estimated glomular filtration rate from baseline to study exit (an average of 3-months).
Outcome measures
| Measure |
Daily Diuretic Adjustment
n=21 Participants
Daily adjustments of diuretics and associated supplements based on cardiac filling pressures.
Diuretics: Daily adjustments of diuretics and associated supplements based on cardiac filling pressures.
|
|---|---|
|
Estimate Changes in Clinical Markers of Heart Failure and Kidney Function
|
0 mL/min per 1.73 m^2
Standard Deviation 14.2
|
SECONDARY outcome
Timeframe: Baseline through Completion/Exit (an average of 3-months)Population: Subjects with blood urea nitrogen values at both the baseline and study exit visits
Changes in blood urea nitrogen from baseline to study exit (an average of 3-months).
Outcome measures
| Measure |
Daily Diuretic Adjustment
n=21 Participants
Daily adjustments of diuretics and associated supplements based on cardiac filling pressures.
Diuretics: Daily adjustments of diuretics and associated supplements based on cardiac filling pressures.
|
|---|---|
|
Estimate Changes in Clinical Markers of Heart Failure and Kidney Function
|
1 mg/dL
Standard Deviation 6.2
|
Adverse Events
Daily Diuretic Adjustment
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Daily Diuretic Adjustment
n=21 participants at risk
Daily adjustments of diuretics and associated supplements based on cardiac filling pressures.
Diuretics: Daily adjustments of diuretics and associated supplements based on cardiac filling pressures.
|
|---|---|
|
Cardiac disorders
Cardiac Failure
|
4.8%
1/21 • Number of events 1 • All serious adverse events, cardiovascular related adverse events, and events related to the IPC system were captured from study enrollment through the study exit (approximately 60 days post-enrollment)
|
|
Cardiac disorders
Myocardial Infarction
|
4.8%
1/21 • Number of events 1 • All serious adverse events, cardiovascular related adverse events, and events related to the IPC system were captured from study enrollment through the study exit (approximately 60 days post-enrollment)
|
|
Psychiatric disorders
Mental status change
|
4.8%
1/21 • Number of events 1 • All serious adverse events, cardiovascular related adverse events, and events related to the IPC system were captured from study enrollment through the study exit (approximately 60 days post-enrollment)
|
Other adverse events
| Measure |
Daily Diuretic Adjustment
n=21 participants at risk
Daily adjustments of diuretics and associated supplements based on cardiac filling pressures.
Diuretics: Daily adjustments of diuretics and associated supplements based on cardiac filling pressures.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
4.8%
1/21 • Number of events 1 • All serious adverse events, cardiovascular related adverse events, and events related to the IPC system were captured from study enrollment through the study exit (approximately 60 days post-enrollment)
|
|
Cardiac disorders
Cardiac failure
|
4.8%
1/21 • Number of events 1 • All serious adverse events, cardiovascular related adverse events, and events related to the IPC system were captured from study enrollment through the study exit (approximately 60 days post-enrollment)
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
4.8%
1/21 • Number of events 1 • All serious adverse events, cardiovascular related adverse events, and events related to the IPC system were captured from study enrollment through the study exit (approximately 60 days post-enrollment)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
9.5%
2/21 • Number of events 2 • All serious adverse events, cardiovascular related adverse events, and events related to the IPC system were captured from study enrollment through the study exit (approximately 60 days post-enrollment)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
4.8%
1/21 • Number of events 1 • All serious adverse events, cardiovascular related adverse events, and events related to the IPC system were captured from study enrollment through the study exit (approximately 60 days post-enrollment)
|
|
Infections and infestations
Urinary tract infection
|
4.8%
1/21 • Number of events 1 • All serious adverse events, cardiovascular related adverse events, and events related to the IPC system were captured from study enrollment through the study exit (approximately 60 days post-enrollment)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place