The main aim of the present study is to validate a predictive multiparametric algorithm to predict the response to CRT in terms of the amount of decrease in LV end systolic volume (LVESV). The model combines typical left bundle branch block (LBBB)…
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Prediction by the new composite algorithm of the degree of response on
CRT, defined as %decrease in LVESV at 6 months
Secondary outcome
- Additional improvement in prediction of the degree of response by
exploring secondary potential markers for response to CRT
- Prediction by the new composite algorithm of the degree of response on CRT,
defined as %increase in LV ejection fraction (LVEF) points at 6 months
- Change in ECG and three-dimensional vectorcardiography (VCG) at 6 months of
CRT
- Changes in NT-pro-BNP and other known and future biomarkers levels at 6
months of CRT
- Change in NYHA functional class at 6 months of CRT
- Change in Quality of Life scores assessed by means of the *Minnesota Living
with Heart Failure Questionnaire* and EuroQol at 6 months of CRT
- Change in the six minutes hall walk test (6MWT) at 6 months of CRT
- Repolarization changes obtained with 3-dimensional VCG at 1, 5, 10 days, 1,
3 and 6 months of CRT
- Changes in echocardiographic parameters of diastolic heart function as well
as heterogeneity in time to peak longitudinal strains at 1, 5, 10 days, 1, 3
and 6 months of CRT
- Occurrence of arrhythmias at 1, 5, 10 days, 1, 3 and 6 months of CRT
Background summary
In patients with heart failure and wide QRS-complex cardiac resynchronization
therapy (CRT) is indicated. This therapy often results in restoration of a more
synchronous ventricular contraction pattern, improves left ventricular (LV)
systolic function and reverses ventricular remodeling in large groups of
patients. At the individual level, the effect is difficult to predict and
approximately one third of patients do not improve by this therapy. Moreover,
diastolic function is hardly affected at all by CRT.
Study objective
The main aim of the present study is to validate a predictive multiparametric
algorithm to predict the response to CRT in terms of the amount of decrease in
LV end systolic volume (LVESV). The model combines typical left bundle branch
block (LBBB) pattern on the electrocardiogram (ECG), interventricular
mechanical delay, septal rebound stretch, QRS duration, non ischemic
cardiomyopathy and estimated glomerular filtration rate (eGFR) (acronym:
LISQNE). Our secondary objective is to retrospectively fine-tune the algorithm
by evaluating other baseline indices and early predictors of CRT response.
Study design
This study comprises a prospective validation study with secondary post-hoc
analyses.
Study burden and risks
Patients participating in this study need to visit the hospital one extra time
on top of regular care. Furthermore, at two different time points blood samples
will be collected by venapunction. In addition, physical examination (blood
pressure, length and weight), echocardiography, electrocardiogram,
3-dimensional VCG, holter monitoring, reading out of pacemaker/ ICD, six
minutes hall walk test and the Minnesota Living with Heart Failure
Questionnaire and EuroQol will be obtained before implantation as well as 6
months after implantation. Besides small physical and psychological discomfort
associated with the clinical investigations, no risks are caused by this
proposed study (only standard routine investigations).
Stenenwal 15
6221 GA Maastricht
NL
Stenenwal 15
6221 GA Maastricht
NL
Listed location countries
Age
Inclusion criteria
Inclusion criteria are:
* Indication for CRT (made by the cardiologist independently of the study)
* Age >18 years
* Capable of giving informed consent
Exclusion criteria
Exclusion criteria are:
* Any known condition that could limit life expectancy <6 months
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 |
|---|---|
| CCMO | NL33779.068.10 |