Cardiac Resynchronization Therapy (CRT)-Narrow-dp/Dt-Study
Phase 4
Completed
- Conditions
- Heart Failure
- Registration Number
- NCT00821938
- Lead Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Brief Summary
Goal is to examine the efficy of Cardiac Resynchronization Therapy in heart failure patients with narrow QRS complex and optimized medical treatment but echocardiographic desynchronization detection as well as the positve increase of the intraoperative pressureincreasespeed in reverse remodelling and a secondary improvement of functional parameters
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
- EF < 35%
- CHD or dilate cardiomyopathy
- sinus rhythm
- NYHA III (or IV but stable recompenstated)
- QRS < 120 ms 2-3 of the following:
- LV-fillingtime < 40% of the cyclelength
- TDI septal-lateral (LV basal) > 60ms
- 2D-Strain-Score > 9 points
Exclusion Criteria
- tricuspid or artificial valve
- AV block II or III or PQ time > 250ms
- revasculisation or condition after cardiac surgery < 3 months
- myocardial infarction or bypass OP < 3 months
- hytertrphic obstructive cardiomyopathy, constrictive pericarditis
- intravenous catecholamines because of HF
- manifeste hyperthyreoses
- kidney failure (creatine >2,5 mg/dl)
- no written informed consent
- no compliance
- participation in another study
- life expectancy < 1 year
- patients < 18 years
- pragnancy or no safe contraception
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Indexed left ventricular volume 12 months
- Secondary Outcome Measures
Name Time Method NYHA-class, 6 minute hallwalk, QOL, BNP-level, echo-criteria 12 months
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie CRT efficacy in narrow QRS heart failure patients with echocardiographic desynchronization?
How does CRT in narrow QRS heart failure patients compare to standard-of-care treatments in terms of reverse remodeling and functional outcomes?
Which biomarkers are associated with positive LV dp/dt response to CRT in narrow QRS complex heart failure patients?
What adverse events are commonly reported in CRT trials for narrow QRS heart failure patients and how are they managed?
Are there combination therapies or alternative approaches to CRT for treating narrow QRS desynchronized heart failure patients?
Trial Locations
- Locations (1)
Schuechtermann-Kliniken
🇩🇪Bad Rothenfelde, Germany
Schuechtermann-Kliniken🇩🇪Bad Rothenfelde, Germany