heart failure and cardiac decompensation
Conditions
Interventions
None listed
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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) = 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| • 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 | — |
Countries
Netherlands
Outcome results
None listed