Viability and Cardiac Resynchronization Therapy
|ClinicalTrials.gov Identifier: NCT00955539|
Recruitment Status : Unknown
Verified October 2011 by Niels Risum, University Hospital, Gentofte, Copenhagen.
Recruitment status was: Recruiting
First Posted : August 10, 2009
Last Update Posted : October 6, 2011
|Condition or disease||Intervention/treatment|
|Heart Failure Ischemic Cardiomyopathy||Device: AV-optimization followed by AV- and VV-optimization Device: AV- and VV-optimization followed by AV-optimization only.|
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 demonstrated unequivocal improvements in functional status, morbidity and mortality. However, 30 % of heart failure patients treated with a CRT-device do not benefit clinically. Several factors have been suggested to be important for the response to CRT such as mechanical dyssynchrony, presence of scar tissue in the myocardium, and device-optimization (among others). It is the purpose of this study to investigate the importance of these factors.
100 patients with ischemic cardiomyopathy, eligible to CRT according to current guidelines, will be included. Patients are randomised to two arms. One group will have atrioventricular (AV)-optimization after implantation, the other AV -and interventricular (VV)-optimization. After 4 months patients are crossed-over to the other arm. Preimplantation patients are MR-scanned and low-dose dobutamine stress-echocardiography is performed. Furthermore patients will be examined by echocardiography and evaluation of clinical status
- Mechanical dyssynchrony can predict response to CRT. b. Measures of mechanical dyssynchrony is related to myocardial viability and conduction.
- Individual optimization based on conduction times will increase benefit to CRT. b. The effect of adding VV-optimization is related to myocardial viability.
- > 30 % of non-viable tissue globally in the myocardium is predictive of lack of CRT- response. b. Non-viable tissue located in the area of the left ventricular lead is predictive of non-response.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||The Importance of Viability for Response to Cardiac Resynchronization Therapy|
|Study Start Date :||August 2009|
|Estimated Primary Completion Date :||December 2012|
|Estimated Study Completion Date :||June 2013|
|Active Comparator: CRT group 1||
Device: AV-optimization followed by AV- and VV-optimization
Patients are AV-optimized the first 4 months,then AV- and VV-optimized the next 4 months.
|Active Comparator: CRT group 2||
Device: AV- and VV-optimization followed by AV-optimization only.
Patients are AV- and VV-optimized the first 4 months,then AV-optimized the next 4 months.
- Responders:Echocardiographic:>/= 10% increase in Left ventricular ejection fraction (LVEF) or >/= 15 % reduction in left ventricular end-systolic volume (LVESV) [ Time Frame: 4 and 8 months, ( follow up- 2 years) ]
- LVESV, LVEDV, Cardiac output (CO), Minnesota Living with Heart Failure Questionnaire (MLHFQ) ProBNP Others: t-wave modulation all-cause mortality, cardiac death, hospitalization [ Time Frame: 4 and 8 months (follow-up after 2 years) ]
- Clinical: >/= 25% increase in 6-min walk test or >/= 1 reduction in NYHA-class [ Time Frame: 4 and 8 months (follow-up 2 years) ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00955539
|Contact: Niels Risum, M.D.||+45 email@example.com|
|Contact: Thomas Fritz Hansen, M.D.||+45 39773977||THHAN@geh.regionh.dk|
|Gentofte University Hospital||Recruiting|
|Hellerup, Denmark, 2900|
|Contact: Niels Risum, M.D. +45 39978473 firstname.lastname@example.org|
|Contact: Thomas Fritz Hansen, M.D. +45 39773977 THHAN@geh.regionh.dk|
|Principal Investigator: Niels Risum, M.D.|
|University Hospital Lund||Recruiting|
|Lund, Sweden, 221 85|
|Contact: Rasmus Borgquist, MD, PhD +46 70-4057350 email@example.com|
|Principal Investigator: Rasmus Borgquist, MD, PhD|
|Principal Investigator:||Niels Risum, M.D.||University Hospital Gentofte, Department of cardiology|
|Study Chair:||Thomas Fritz Hansen, M.D.||University Hospital Gentofte, department of cardiology|
|Study Chair:||Peter Søgaard, M.D., DMSc.||Gentofte University Hospital, department of cardiology|
|Study Chair:||Rasmus Borgquist, MD, PhD||University Hospital Lund|
|Study Chair:||Niels E Bruun, MD, DMSc||Gentofte University Hospital, department of cardiology|