Heart Failure
Conditions
Keywords
Heart Failure, randomized, OptiVol® Fluid status monitoring
Brief summary
The DOT-HF trial is an international, prospective, multi-center, randomized, controlled trial.
Detailed description
The study was designed with a Control Arm in order to adequately study the effect of early intervention triggered by the OptiVol® Alert and/or SentryCheck™ Monitor/PatientLook™ Indicator and evaluation using OptiVol® Fluid Status Monitoring with Cardiac Compass. OptiVol® Fluid Status Monitoring with Cardiac Compass features are available in the per Clinical Investigational Plan specified Medtronic products (CRT, CRT-D and ICD devices)
Interventions
DEVICEProgramming (CRT-D, ICD OptiVol® and Cardiac Compass® )
OptiVol® Fluid status Monitoring with Cardiac Compass
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Intervention: in the access arm the patiens had programmmed the audible OptiVol Fliud status alert on. Control patienst had programmed the audible alert off
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects of both genders with mild to severe HF as defined as NHYA Class II to IV who also have an indication for device implant according to ESC/AHA guidelines as well as having a HF hospitalization or Emergency Department visit necessitating therapy within the past 12 months and who meet all inclusion criteria and no
Exclusion criteria
, are eligible for this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Combined End Point of All-cause Mortality or Heart Failure Hospitalization | 14.9 ± 5.4 months | Number of participants with a combined end point of all-cause mortality or heart failure hospitalization |
Countries
Netherlands
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Access Arm HF subjects managed with standard clinical assessment and using OptiVol® Fluid status monitoring with Cardiac Compass Report
Programming (CRT-D, ICD OptiVol® and Cardiac Compass® ): OptiVol® Fluid status Monitoring with Cardiac Compass | 168 |
| Control Arm HF subjects managed with standard clinical assessment
Programming (CRT-D, ICD OptiVol® and Cardiac Compass® ): OptiVol® Fluid status Monitoring with Cardiac Compass | 167 |
| Total | 335 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 19 | 15 |
| Overall Study | early exit | 12 | 11 |
Baseline characteristics
| Characteristic | Access Arm | Control Arm | Total |
|---|---|---|---|
| Age, Continuous | 64 years STANDARD_DEVIATION 10 | 64 years STANDARD_DEVIATION 10 | 64 years STANDARD_DEVIATION 10 |
| Body Mass Index | 28 kg/m^2 STANDARD_DEVIATION 5 | 27 kg/m^2 STANDARD_DEVIATION 4 | 28 kg/m^2 STANDARD_DEVIATION 4 |
| LVEF | 25 % STANDARD_DEVIATION 7 | 25 % STANDARD_DEVIATION 7 | 25 % STANDARD_DEVIATION 7 |
| NYHA functional class NYHA functional class I | 6 participants | 5 participants | 11 participants |
| NYHA functional class NYHA functional class II | 98 participants | 103 participants | 201 participants |
| NYHA functional class NYHA functional class III | 63 participants | 58 participants | 121 participants |
| NYHA functional class NYHA functional class IV | 1 participants | 1 participants | 2 participants |
| QRS duration | 142 ms STANDARD_DEVIATION 39 | 143 ms STANDARD_DEVIATION 36 | 142 ms STANDARD_DEVIATION 38 |
| Sex: Female, Male Female | 22 Participants | 25 Participants | 47 Participants |
| Sex: Female, Male Male | 146 Participants | 142 Participants | 288 Participants |
| Type of device implanted CRT-D | 141 Participants | 133 Participants | 274 Participants |
| Type of device implanted ICD | 27 Participants | 34 Participants | 61 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 47 / 168 | 20 / 167 |
| serious Total, serious adverse events | 50 / 168 | 34 / 167 |
Outcome results
Primary
Number of Participants With Combined End Point of All-cause Mortality or Heart Failure Hospitalization
Number of participants with a combined end point of all-cause mortality or heart failure hospitalization
Time frame: 14.9 ± 5.4 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Access Arm | Number of Participants With Combined End Point of All-cause Mortality or Heart Failure Hospitalization | 48 Participants |
| Control Arm | Number of Participants With Combined End Point of All-cause Mortality or Heart Failure Hospitalization | 33 Participants |
p-value: 0.063Log Rank