Heart Failure, Congestive
Conditions
Keywords
heart failure, diagnostics, heart sounds, CRT-D, ICD, remote monitoring
Brief summary
The MANAGE-HF study is a multi-center, global, prospective, open label, multi-phase trial intended to evaluate the clinical efficacy of the HeartLogic heart failure diagnostic feature.
Detailed description
Phase I of the MANAGE-HF trial is not randomized, and is intended to evaluate the clinical integration of HeartLogic for managing patients with heart failure. There are no endpoints. Phase II of the MANAGE-HF trial will assess the clinical effectiveness of remote monitoring of heart failure patients with implanted CRT-D or ICD cardiac devices that contain the diagnostic feature HeartLogic. This feature uses S1 and S3 heart sounds, night time heart rate, thoracic impedance, and respiration to alert clinicians when a patient's heart failure is worsening. The MANAGE-HF study will compare remote monitoring using HeartLogic alerts to drive heart failure care against patients with remote monitoring but without HeartLogic alerts.
Interventions
DEVICEHeartLogic ON
Remote management of patients with CRT-D or ICD devices and the HeartLogic diagnostic feature turned OFF
DEVICEHeartLogic OFF
Remote management of patients with CRT-D or ICD devices and the HeartLogic diagnostic feature turned ON
Sponsors
Boston Scientific Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject is age 18 or above, or of legal age to give informed consent 2. Implanted with an cardiac resynchronization therapy defibrillator (CRT-D) or implantable cardioverter-defibrillator (ICD) device that has HeartLogic 3. Current symptomatic heart failure or New York Heart Association Class II or III at the time of enrollment 4. Remotely monitored by LATITUDE 5.0 (or future versions) 5. Willing and capable of participating in all study visits and complying with medication/treatment requirements associated with this clinical study at an approved clinical study center. 6. Meet at least one of the three following conditions: * At least one documented hospitalization with a primary diagnosis of worsening for heart failure during the 12 months prior to enrollment; or * Unscheduled outpatient visit with IV diuretic therapy for acute worsening of HF during 90 days prior to enrollment; or * N-terminal-pro brain natriuretic peptide (NT-proBNP) greater than 600 pg/mL or brain natriuretic peptide (BNP) greater than 150 pg/mL at any time during 90 days prior to enrollment
Exclusion criteria
1. The subject is unable to sign or refuses to sign the patient informed consent 2. Symptomatic heart failure at rest or New York Heart Association Class IV at the time of enrollment 3. The subject is implanted with unipolar right atrial or right ventricular leads 4. Subject has received or is scheduled to receive a heart transplant or ventricular assist device within the next 6 months 5. Subject is pregnant or planning to become pregnant during the study 6. Subject is enrolled in any other concurrent study (without prior written approval from Boston Scientific, excluding registries) 7. Glomerular filtration rate \<25 mL/min who are non-responsive to diuretic therapy or are on chronic renal dialysis 8. Regularly scheduled intravenous heart failure therapy (for example inotropes or diuretics) 9. A life expectancy of less than 12 months per clinician discretion 10. APPLICABLE TO PHASE II ONLY: Subject enrolled in Phase I of MANAGE-HF 11. APPLICABLE TO PHASE II ONLY: Subject has been managed with HeartLogic Alerts ON at anytime within the past 6 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Manage-HF Phase I | Data was collected from the time of consent until the last Phase I subject had completed their 12-month visit | Phase-I was a single arm non-randomized study used to evaluate and optimize HeartLogic clinical integration and alert management. Phase-I had no outcome measures. |
Countries
France, Germany, United States
Participant flow
Recruitment details
Manage-HF Phase I began recruitment in August of 2017 and completed recruitment in May of 2019. Last Patient Last visit for Phase I occurred in July of 2020. MANAGE HF Phase I was determined to be sufficient by FDA on January 31, 2023, and phase II was not started.
Participants by arm
| Arm | Count |
|---|---|
| MANAGE-HF Phase I Two hundred subjects were enrolled in Phase I of MANAGE-HF. One hundred forty-four subjects were followed until the last patient enrolled completed his or her12-month visit.
Thirty-seven subjects withdrew and 19 subjects died. | 191 |
| Total | 191 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 19 |
| Overall Study | Withdrawal by Subject | 37 |
Baseline characteristics
| Characteristic | MANAGE-HF Phase I |
|---|---|
| Age, Continuous | 67 years STANDARD_DEVIATION 12 |
| Asthma | 12 Participants |
| CABG | 49 Participants |
| Chronic Obstructive Pulmonary Disease | 28 participants |
| Diabetes | 69 Participants |
| Dilated Cardiomyopathy | 75 Participants |
| Heart Failure Hospitalization | 112 Participants |
| Hypertension | 144 Participants |
| Idiopathic Cardiomyopathy | 20 Participants |
| Ischemic Heart Disease | 90 Participants |
| LVEF (%) | 25.6 % STANDARD_DEVIATION 9.5 |
| Peripheral Vascular Disease | 25 Participants |
| Previous Myocardial Infarction | 73 Participants |
| Pulmonary diseases other | 13 Participants |
| Pulmonary hypertension | 14 Participants |
| QRS duration (ms) | 135 ms STANDARD_DEVIATION 31 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 28 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 19 Participants |
| Race (NIH/OMB) White | 142 Participants |
| Region of Enrollment France | 14 participants |
| Region of Enrollment Germany | 6 participants |
| Region of Enrollment United States | 171 participants |
| Renal dysfunction | 50 Participants |
| RVEF (%) | 49.3 % STANDARD_DEVIATION 12.5 |
| Sex: Female, Male Female | 62 Participants |
| Sex: Female, Male Male | 129 Participants |
| Thoracic surgery | 18 Participants |
| Valvular disease | 48 Participants |
| Valvular surgery | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 19 / 200 |
| other Total, other adverse events | 104 / 200 |
| serious Total, serious adverse events | 100 / 200 |
Outcome results
Primary
Manage-HF Phase I
Phase-I was a single arm non-randomized study used to evaluate and optimize HeartLogic clinical integration and alert management. Phase-I had no outcome measures.
Time frame: Data was collected from the time of consent until the last Phase I subject had completed their 12-month visit
Population: Manage-HF Phase II was not started, the trial was closed after phase I
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MANAGE-HF Phase I | Manage-HF Phase I | 191 Participants |