Status:
UNKNOWN
Viability and Cardiac Resynchronization Therapy
Lead Sponsor:
University Hospital, Gentofte, Copenhagen
Collaborating Sponsors:
Lund University Hospital
Rigshospitalet, Denmark
Conditions:
Heart Failure
Ischemic Cardiomyopathy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
30% of heart failure patients that receive a device for cardiac resynchronization therapy fail to show clinical improvement. The reason for lack of response is still unclear but factors such as scar t...
Detailed Description
Cardiac resynchronization therapy (CRT) is an established therapy for patients with severe heart failure, depressed left ventricular function and a wide QRS-complex. Large clinical trials have demonst...
Eligibility Criteria
Inclusion
- LVEF\</= 35%, QRS-duration\>/= 120 ms, NYHA-class II- IV.
- Ischemic heart disease (\> 50% stenosis in 1 or more major epicardial coronary artery or prior PCI or CABG.)
- Optimal treatment ( beta-blocker, ACE-1 or ARB and spironolactone)
Exclusion
- Pregnancy
- Unstable angina pectoris
- Chronical atrial fibrillation
- Severe valvular disease
- Dementia or mental retardation
- Severe claustrophobia
- Acute myocardial infarction \< 3 months
- Severe health condition threatening short-term survival
- Severe kidney insufficiency, GFR \< 35 ml/min/1.73 m2
- Metal implants contraindicative of magnetic resonance scan
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2013
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00955539
Start Date
August 1 2009
End Date
June 1 2013
Last Update
October 6 2011
Active Locations (2)
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1
Gentofte University Hospital
Hellerup, Denmark, 2900
2
University Hospital Lund
Lund, Lund, Sweden, 221 85