To investigate the relation of a set of (bio)markers and response to Cardiac Resynchronization Therapy (CRT); the interrelationship as well as the potential predictive power of these (bio)markers on improvement and/or deterioration of cardiac…
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To investigate the relationship between a set of (bio)markers and response to
cardiac resynchronization therapy at 6 months. This will be measured by
echocardiography and will encountered mainly the Left Ventricular End-Systolic
Volume Index (LVESVi).
The biomarkers include:
• Genomics: candidate gene approach, microRNA*s (analysis at study end; final
list of micro-RNA*s to be determined at study end).
• Blood markers (serum or plasma) are but not limited to biomarkers of
fibrosis, inflammation, cardiac damage, hemodynamic stress and extra-cardiac
markers.
• Echo 2D-Speckle Tracking: Radial Strain, Septal Rebound Stretch, standard
deviation of Time to peak systolic Strain (final set of parameters to be
determined at study end).
• Electrocardiography: Beat-to-beat Variability of Repolarization (BVR) /
Short-Term Variability (STV) and extra stimulus protocol.
• Echocardiography: function and structure (including but not limited to LVEDD,
LVESV, LVEDV, LVESVi, LVEF, MR, LVFT, IVMD, atrial volumina), in combination
with electrocardiographic investigation: PA-TDI (P-wave duration).
• Clinical parameters including coronary artery disease, Body Mass Index,
gender, Myocardial Infarction at baseline.
Secondary outcome
• To investigate the relationship between a set of (bio)markers and response to
cardiac resynchronization therapy (as measured by echocardiography) at 12 months
• To investigate the relationship between (bio)markers and atrial fibrillation
during follow-up
• To investigate the relationship between (bio)markers and ventricular
tachycardia/ fibrillation and/or appropriate shocks during follow-up
• To investigate the relationship between (bio)markers and reverse remodeling
Background summary
Cardiac Resynchronization Therapy is a therapy that is delivered by a small
electronic medical device which can help the heart pump blood throughout the
body more efficiently and may improve symptoms associated with heart failure.
Patients who required this therapy have two sides of the heart which do not
beat in synchrony with each other, and as a result, the amount of blood that is
pumped out of your heart is reduced. This reduction in your heart*s ability to
pump may be contributing to symptoms such as shortness of breath or decreased
ability to do activities of daily living. However, there are some patients who
do not have an improvement of symptoms or an improvement of ability of the
heart to pump.
Study objective
To investigate the relation of a set of (bio)markers and response to Cardiac
Resynchronization Therapy (CRT); the interrelationship as well as the potential
predictive power of these (bio)markers on improvement and/or deterioration of
cardiac function, cardiac geometry (reverse re-modeling during CRT) will be
evaluated.
Study design
This is a multi-center, exploratory, prospective, interventional post-market
release, non-randomized, study.
Study burden and risks
Most study-specific testing procedures required for this study are tests that
are frequently and routinely performed for heart failure patients. However, the
number of required tests (4 x blood sampling and 1x : 6-min hall walk test at
month 12) might be higher then done for routinely scheduled in-hospital
clinical visits. Considering the very limited risks that are associated with
these procedures, these risks do not weigh up to the new information that is
being acquired on pathophysiology and treatment in heart failure.
Hanzeplein 1
Groningen 9700 RB
NL
Hanzeplein 1
Groningen 9700 RB
NL
Listed location countries
Age
Inclusion criteria
• Subject is indicated for CRT-D device according to current applicable ESC/AHA guidelines
• Subject has NYHA class II or III
• Subject has stable sinus rhythm (no atrial arrhythmias lasting > 30 seconds during the last 2 weeks prior to inclusion) No documented AF-episodes allowed during the last 2 weeks prior to inclusion.
• Intrinsic QRS-width >= 130 ms with LBBB or >= 150ms without LBBB as measured within 30 days prior to device implant for subjects with NYHA class II
• Intrinsic QRS-width >= 120 ms with LBBB or >= 150 ms without LBBB as measured within 30 days prior to device implant for subjects with NYHA class III
• Subject receives optimal heart failure oral medical therapy (ACE inhibitor and/or ARB and Beta Blockers), and is on a stable medication scheme for at least 1 month prior to enrollment
• Subject is willing to sign informed consent form
• Subject is 18 years or older
Exclusion criteria
• Subject is upgraded from a bradycardia pacemaker to CRT-D
• Subject receives CRT-D replacement or is upgraded from CRT-P to CRT-D
• Subject has permanent atrial fibrillation/ flutter or tachycardia
• Subject experienced recent myocardial infarction (MI), within 40 days prior to enrollment
• Subject underwent coronary artery bypass graft (CABG) or valve surgery, within 90 days prior to enrollment
• Subject is post heart transplantation, or is actively listed on the transplantation list, or has reasonable probability (per investigator*s discretion) of undergoing transplantation in the next year
• Subject is implanted with a left ventricular assist device (LVAD), or has reasonable probability (per investigator*s discretion) of receiving a LVAD in the next year
• Subject is on chronic renal dialysis
• Subject has severe renal disease (defined as Glomerular Filtration Rate (GFR) < 30 mL/min/1.73m2)
• Subject is on continuous or uninterrupted infusion (inotropic) therapy for heart failure (>= 2 stable infusions per week)
• Subject has RBBB
• Subject has permanent 2nd or 3rd degree AV-block
• Subject has severe aortic stenosis (with a valve area of <1.0 cm2 or significant valve disease expected to be operated within study period)
• Subject has complex and uncorrected congenital heart disease
• Subject has a mechanical right heart valve
• Subject has a life expectancy of less than one year in the opinion of the investigator
• Pregnant or breastfeeding women, or women of child bearing potential and who are not on a reliable form of birth control
• Subject is enrolled in one or more concurrent studies that would confound the results of this study
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 | NL37342.042.11 |