To demonstrate that CNBP can be used for CRT device settings adjustment aimed atoptimization of clinical status of chronic HF patients
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Difference of 3.5% in left ventricular ejection fraction between both
strategies measured by 3-D echocardiography.
Secondary outcome
Changes in NYHA classification, NT-pro-BNP, 6-MWT, and QOL score assessed by the
Minnesota Living with Heart Failure questionnaire, LVEDD, LVESD, LVEDV and
LVESV, MR, incidence of ventriculartachycardia
or fibrillation (VT, VF), ICD delivered antitachycardia pacing (ATP) and
shocks, days of hospitalization
for or associated with worsening HF and mortality of any cause.
Background summary
In selected heart failure (HF) patients cardiac resynchronization therapy (CRT)
is an accepted treatment. However, a consistent percentage of patients show no
benefit after CRT. Improvement of hemodynamic
and clinical status after changing the initial settings of a CRT device after
implantation has been suggested.
Currently, there is no general consensus on the best tool to evaluate the
effectiveness of changes of device
setting. Although being time consuming and operator dependent, at present
echocardiography (TTE) is the most
widely used tool. An alternative, easy and accurate method for the
identification of hemodynamic changes is continuous non-invasive blood pressure
measurement (CNBP). Three studies have demonstrated acute
hemodynamic improvement in patients following CRT device settings adjustments
using CNBP. However, in none
of these studies follow-up assessment of clinical outcome was performed.
Study objective
To demonstrate that CNBP can be used for CRT device settings adjustment aimed at
optimization of clinical status of chronic HF patients
Study design
This is a randomized, single-blinded, treatment crossover, prospective study.
Patients will be randomized (1:1) to 1) CNBP-guided device settings adjustments
of atrioventricular (AV-) and interventricular (VV) delay 1-2 weeks after
device implantation aimed at improvement of cardiac output and dP/dt, or 2) *No
adjustments* using a standard AV- and VV delay. Different HF endpoints will be
assessed at 3 months follow-up and crossover to the other strategy will take
place. After another 3 months follow-up (6 month after device settings
adjustments) the same HF endpoints will be assessed. Differences between both
strategies will be evaluated by comparing the measured endpoints.
Study burden and risks
CNBP may be useful for device adaptations aimed at optimization of the clinical
status of chronic HF patients. Being noninvasive, all risks can be considered
negligible.
Koekoekslaan 1
3430 EM Nieuwegein
NL
Koekoekslaan 1
3430 EM Nieuwegein
NL
Listed location countries
Age
Inclusion criteria
1) End stage heart failure with NYHA class II, III or IV despite optimal medical treatment 2) QRS duration > 120msec for patients in NYHA class III or IV, QRS duration > 150msec for patients in NYHA class II
3) Left ventricular ejection fraction < 35%
Exclusion criteria
1) Age < 18 years
2) Planned revascularization therapy or reparative cardiac surgery <6 months
3) Expected heart transplantation <1 year
4) Severe heart failure with short (<6 months) life expectancy
5) Chronic atrial fibrillation
Design
Recruitment
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 |
|---|---|
| Other | In behandeling |
| CCMO | NL27701.100.09 |