READMIT-HF: REducing 30-day ADMIssions in posT-discharge Subjects (READMIT)
Study Details
Study Description
Brief Summary
The purpose of this observational study is to collect and characterize multiple physiologic data from a broad subset of subjects with acute heart failure (HF)
Changes in physiologic data are expected to correlate with 30-day readmission rates in this population
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
This is a multi-center, non-randomized feasibility study aimed at obtaining data from systolic and diastolic HF subjects in the hospital, with continued monitoring using an external wearable monitor for up to 4 weeks post-hospital-discharge. Data will be collected during the hospital stay and at in office follow-up visits at 1 week and 1 month post-hospital discharge
The data will help generate hypotheses and aid in determining whether development of a detection algorithm for acute heart failure decompensation is feasible. Due to the feasibility nature of this study there is no minimum required sample size but it is anticipated that the study will enroll up to 100 subjects from seven (7) study sites in the United States and one (1) study site in Australia
The study objectives are:
-
Collect and characterize physiologic data from subjects with acute decompensated heart failure.
-
Characterization of data related to health care utilizations within 30-days Post-discharge
-
Correlation between patch monitor collected data and inpatient clinical data
-
Correlation between patch monitor data and other clinical data collected after patient discharge (30-60 days)
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| AVIVO™ PiiX Patch Monitor System Heart failure patients monitored continuously for 30 days post-discharge. |
Device: AVIVO™ PiiX Patch Monitor System
External monitoring for 30 days post-discharge.
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants With Health Care Utilizations [30 days post-discharge]
Percentage of Participants with health care utilizations. Healthcare utilizations include hospitalizations, urgent care visits and emergency department visits.
Secondary Outcome Measures
- Change in Body Weight Per Unit Change in Thoracic Impedance [Discharge to 30 days post discharge]
Change in body weight per unit change in thoracic impedance. The regression coefficients between body weight and thoracic impedance.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Subject with acute decompensated heart failure
-
Subject (or legal guardian) willing to give consent for their participation
-
Subject ≥18 years of age
Exclusion Criteria:
-
Subject who is expected to receive a heart transplant or a ventricular assist device within 6 months
-
Subject who cannot tolerate placement of external patch monitor on chest in the proposed location (ECG Lead II orientation)
-
Subject with known allergies or hypersensitivities to adhesives or hydrogels
-
Subject with implantable devices with active minute ventilation sensors.
-
Subject who will not comply to study protocol requirements. This includes completing required data collection, and attending required follow up study visits.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Scripps Green Hospital | La Jolla | California | United States | 92037 |
| 2 | Bay Area Cardiology | Tampa | Florida | United States | 33511-5908 |
| 3 | United Heart and Cardiovascular | Saint Paul | Minnesota | United States | 55102-2568 |
| 4 | Morristown Memorial Hospital | Morristown | New Jersey | United States | 07962 |
| 5 | Mohawk Valley Heart Institute | Utica | New York | United States | 13501-5930 |
| 6 | University of Cincinnati | Cincinnati | Ohio | United States | 45219-2364 |
| 7 | Vanderbilt University | Nashville | Tennessee | United States | 37232 |
| 8 | The Alfred Hospital | Melbourne | Victoria | Australia | 3004 |
Sponsors and Collaborators
- Medtronic Cardiac Rhythm and Heart Failure
Investigators
- Study Director: READMIT-HF Study Team, Medtronic
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- READMIT-HF
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | AVIVO™ PiiX Patch Monitor System |
|---|---|
| Arm/Group Description | Heart failure patients monitored continuously for 30 days post-discharge. AVIVO™ PiiX Patch Monitor System: External monitoring for 30 days post-discharge. |
| Period Title: Overall Study | |
| STARTED | 70 |
| COMPLETED | 70 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Arm/Group Title | AVIVO™ PiiX Patch Monitor System |
|---|---|
| Arm/Group Description | Heart failure patients monitored continuously for 30 days post-discharge. AVIVO™ PiiX Patch Monitor System: External monitoring for 30 days post-discharge. |
| Overall Participants | 70 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
65.2
(13.6)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
28
40%
|
| Male |
42
60%
|
| Region of Enrollment (participants) [Number] | |
| United States |
60
85.7%
|
| Australia |
10
14.3%
|
Outcome Measures
| Title | Percentage of Participants With Health Care Utilizations |
|---|---|
| Description | Percentage of Participants with health care utilizations. Healthcare utilizations include hospitalizations, urgent care visits and emergency department visits. |
| Time Frame | 30 days post-discharge |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | AVIVO™ PiiX Patch Monitor System |
|---|---|
| Arm/Group Description | Heart failure patients monitored continuously for 30 days post-discharge. AVIVO™ PiiX Patch Monitor System: External monitoring for 30 days post-discharge. |
| Measure Participants | 70 |
| Number (95% Confidence Interval) [percent] |
28.6
|
| Title | Change in Body Weight Per Unit Change in Thoracic Impedance |
|---|---|
| Description | Change in body weight per unit change in thoracic impedance. The regression coefficients between body weight and thoracic impedance. |
| Time Frame | Discharge to 30 days post discharge |
Outcome Measure Data
| Analysis Population Description |
|---|
| All subjects with changes of body weight and impedance from discharge to 30 days post discharge. |
| Arm/Group Title | Heart Failure Patients Monitored Continuously With AVIVO PiiX |
|---|---|
| Arm/Group Description | AVIVO™ PiiX Patch Monitor System: External monitoring from enrollment to discharge: regression coefficient |
| Measure Participants | 54 |
| Mean (95% Confidence Interval) [lbs/Ohm] |
-0.03
|
Adverse Events
| Time Frame | From enrollment to 3 months post-discharge | |
|---|---|---|
| Adverse Event Reporting Description | An adverse event (AE) is considered a serious AE if it Lead to death OR Lead to a serious deterioration in subject's health (life threatening illness/injury, permanent impairment of body, hospitalization/prolonged, medical/surgical intervention to prevent the previously mentioned conditions) OR Lead to fetal distress/death/defect | |
| Arm/Group Title | AVIVO™ PiiX Patch Monitor System | |
| Arm/Group Description | Heart failure patients monitored continuously for 30 days post-discharge. AVIVO™ PiiX Patch Monitor System: External monitoring for 30 days post-discharge. | |
All Cause Mortality |
||
| AVIVO™ PiiX Patch Monitor System | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| AVIVO™ PiiX Patch Monitor System | ||
| Affected / at Risk (%) | # Events | |
| Total | 14/70 (20%) | |
| Cardiac disorders | ||
| Atrial Fribrillation | 1/70 (1.4%) | 1 |
| Cardiac Failure Acute | 1/70 (1.4%) | 1 |
| Cardiac Failure congrestive | 4/70 (5.7%) | 4 |
| Supraventricular Tachycardia | 1/70 (1.4%) | 1 |
| Metabolism and nutrition disorders | ||
| HyperKalaemia | 1/70 (1.4%) | 1 |
| Musculoskeletal and connective tissue disorders | ||
| Arthralgia | 1/70 (1.4%) | 1 |
| Nervous system disorders | ||
| Syncope | 2/70 (2.9%) | 2 |
| Psychiatric disorders | ||
| Mental Status Changes | 2/70 (2.9%) | 2 |
| Renal and urinary disorders | ||
| Renal Failure Chronic | 1/70 (1.4%) | 1 |
| Reproductive system and breast disorders | ||
| Scrotal Oedema | 1/70 (1.4%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||
| Chronic Obstructive Pulmonary Disease | 1/70 (1.4%) | 1 |
| Dyspnoea | 1/70 (1.4%) | 1 |
| Pulmonary Hypertension | 1/70 (1.4%) | 1 |
| Vascular disorders | ||
| Arteriovenous Fistula | 1/70 (1.4%) | 1 |
Other (Not Including Serious) Adverse Events |
||
| AVIVO™ PiiX Patch Monitor System | ||
| Affected / at Risk (%) | # Events | |
| Total | 9/70 (12.9%) | |
| Cardiac disorders | ||
| Cardiac Failure congestive | 3/70 (4.3%) | 3 |
| General disorders | ||
| Application Site Bruise | 1/70 (1.4%) | 1 |
| Application Site Rash | 2/70 (2.9%) | 2 |
| Investigations | ||
| Blood Thyroid Stimlating Hormone Increased | 1/70 (1.4%) | 1 |
| Renal and urinary disorders | ||
| Dysuria | 1/70 (1.4%) | 1 |
| Renal Failure Acute | 1/70 (1.4%) | 1 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Amy Lautenbach |
|---|---|
| Organization | Medtronic, Inc |
| Phone | 7633609163 |
| amy.a.lautenbach@medtronic.com@medtronic.com |
- READMIT-HF