The study is being conducted to evaluate whether continuous measurements of Heart Rate Turbulence (HRT), Deceleration Capacity (DC) and Acceleration Capacity (AC) can be used to predict decompensation in Heart Failure patients.Software algorithms…
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Het gecombineerde primaire eindpunt is hartfalen gerelateerde hospitalisatie en
hartfalen gerelateerd overlijden.
Secondary outcome
• Find the best combination of HRT-TO, HRT-TS, DC and AC to differentiate
between the state of a patient at baseline and at during HF related
hospitalization/death.
• Determine the optimal threshold settings (fixed or adaptive) for the
algorithm, in case it
would be used to alarm the patient/physician for HF decompensation.
• Determine the correlation between the Optivol parameter (alert in case of
fluidretention in lungs) and the HRT/DC/AC parameters.
• Determine the correlation between bodyweight and the HRT/DC/AC parameters.
• Characterize the incidence of premature heart contractions (PVCs) in Heart
Failure patients.
• Asses preditive value of HRT/AC/DC in relation to ventricular tachycardias
(VT/VF episodes)
• Determine the correlation between the HRV, Activity, Night HR, VT and AF
parameters, AF parameters (available by default via Cardiac Compass), and the
HRT/DC/AC parameters.
Background summary
The underlying mechanism of the worsened heart-rate regulation in heart failure
patients is largely unknown. Patients at risk at risk for sudden cardiac death
(after myovardial infaction) show an altered compensatory response of the
autonomic nervous system after a premature heart contraction. Moreover, heart
failure is associated with a higher heart rate variability. Deceleration
capacity (DC), acceleration capaciteit (AC) en heart rate turbulence (HRT) can
be computed from the ECG-signal and characterize the status of the autonomic
nervous system.
Research has indicated that for instance HRT is an independent predictor of
death by heart-failure decompensation in patients with moderate to severe heart
failure. Also, HRT relates to functional debilitation (NYHA class) of the
patient. The DECIDE-HF study is unique in investigating the temporal changes in
these parameters within a group of heart failure patients.
Study objective
The study is being conducted to evaluate whether continuous measurements of
Heart Rate Turbulence (HRT), Deceleration Capacity (DC) and Acceleration
Capacity (AC) can be used to predict decompensation in Heart Failure patients.
Software algorithms will measure the state of the compensatory mechanism of the
autonomic nervous system that is related to the heart. If this relates to
worsening heart failure, the algorithms can be incorporated as a monitoring
system in ICDs and pacemakers. An early warning system may alert patients and
physicians in case of heart failure worsening. treatment may be adapted in a
early stage to prevent hospitalization or a further worsening in health.
Study design
This is a multi-center, non-randomized, chronic feasibility study with
investigational download software (RAMware). Maxmally 60 patients will
participate in maximally 5 european centers. We expect the study to start in
august 2009 with a duration between 18 to 30 months. The individual patient
will participate between 12-24 months. Regular practice of the hospital will be
followed so we will not perform extra study-related visits.
Intervention
none
Study burden and risks
• There will be no extra study-related follow-up visits in the hospital
• Patients receive a weighing scale and will be asked to register their weight
daily in a logbook
• The research software possibly uses more battery as a result of which the ICD
may have to be replaced 4 weeks earlier kunnen
• other risks that are as yet unforeseen
• A future monitoring system may be incorporated in ICDs and pacemaker. This
would alerts patients and physicians in an early stage of heart failure
worsening. Treatment may be adapted in a early stage to prevent hospitalization
or a further worsening in health.
Earl Bakkenstraat 10
6422 PJ Heerlen
Nederland
Earl Bakkenstraat 10
6422 PJ Heerlen
Nederland
Listed location countries
Age
Inclusion criteria
1) Dual or triple chamber ICD/CRT-D device implanted for more then 1 month (the device is a Secura® DR, Consulta® CRT-D, Concerto® II CRT-D, Virtuoso® II DR, Maximo® II DR or a Maximo® II CRT-D; at least one sensing lead in the right atrium and one lead in the right ventricle.
2) Systolic Heart Failure and is at the moment of enrollment in NYHA class II or III
3) Linker ventriculaire ejection fraction of less than 40%
4) Patient has had a HF-related hospitalization in the past 12 months
(see protocol p.9)
Exclusion criteria
The patient:
1) needs permanent atrial pacing (>10%)
2) requires additional RAMware downloads after study enrollment
3) has (intermittent) 2nd or intermittent 3rd degree block
4) has persistent or permanent Atrial Fibrillation
5) has had recent (< 2 months) acute coronary syndrome or revascularization
(see protocol p.9-10)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL29069.042.09 |