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Viability and Cardiac Resynchronization Therapy

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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
Sponsor:
Collaborators:
Lund University Hospital
Rigshospitalet, Denmark
Information provided by (Responsible Party):
Niels Risum, University Hospital, Gentofte, Copenhagen

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 tissue in the heart musculature, inadequate lead placement, device-settings and the degree of dyssynchrony before implant seems to be important. In this study, these factors are further investigated.

Condition or disease Intervention/treatment Phase
Heart Failure Ischemic Cardiomyopathy Device: AV-optimization followed by AV- and VV-optimization Device: AV- and VV-optimization followed by AV-optimization only. Not Applicable

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 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

  1. Mechanical dyssynchrony can predict response to CRT. b. Measures of mechanical dyssynchrony is related to myocardial viability and conduction.
  2. Individual optimization based on conduction times will increase benefit to CRT. b. The effect of adding VV-optimization is related to myocardial viability.
  3. > 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
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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) ]

Secondary Outcome Measures :
  1. 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) ]
  2. Clinical: >/= 25% increase in 6-min walk test or >/= 1 reduction in NYHA-class [ Time Frame: 4 and 8 months (follow-up 2 years) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00955539


Contacts
Contact: Niels Risum, M.D. +45 39978473 nieris01@geh.regionh.dk
Contact: Thomas Fritz Hansen, M.D. +45 39773977 THHAN@geh.regionh.dk

Locations
Denmark
Gentofte University Hospital Recruiting
Hellerup, Denmark, 2900
Contact: Niels Risum, M.D.    +45 39978473    nieris01@geh.regionh.dk   
Contact: Thomas Fritz Hansen, M.D.    +45 39773977    THHAN@geh.regionh.dk   
Principal Investigator: Niels Risum, M.D.         
Sweden
University Hospital Lund Recruiting
Lund, Sweden, 221 85
Contact: Rasmus Borgquist, MD, PhD    +46 70-4057350    rasmus.borgquist@med.lu.se   
Principal Investigator: Rasmus Borgquist, MD, PhD         
Sponsors and Collaborators
University Hospital, Gentofte, Copenhagen
Lund University Hospital
Rigshospitalet, Denmark
Investigators
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

Publications:
Responsible Party: Niels Risum, MD, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier: NCT00955539     History of Changes
Other Study ID Numbers: H-B-2009-057
First Posted: August 10, 2009    Key Record Dates
Last Update Posted: October 6, 2011
Last Verified: October 2011

Keywords provided by Niels Risum, University Hospital, Gentofte, Copenhagen:
Heart Failure
Cardiac resynchronization therapy
Optimization
Viability
Mechanical dyssynchrony

Additional relevant MeSH terms:
Heart Failure
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases