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Viability and Cardiac Resynchronization Therapy

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2011 by University Hospital, Gentofte, Copenhagen.
Recruitment status was:  Recruiting
Lund University Hospital
Rigshospitalet, Denmark
Information provided by (Responsible Party):
Niels Risum, University Hospital, Gentofte, Copenhagen Identifier:
First received: August 7, 2009
Last updated: October 4, 2011
Last verified: October 2011
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 Intervention
Heart Failure
Ischemic Cardiomyopathy
Device: AV-optimization followed by AV- and VV-optimization
Device: AV- and VV-optimization followed by AV-optimization only.

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Importance of Viability for Response to Cardiac Resynchronization Therapy

Resource links provided by NLM:

Further study details as provided by University Hospital, Gentofte, Copenhagen:

Primary Outcome Measures:
  • 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:
  • 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) ]

Estimated Enrollment: 100
Study Start Date: August 2009
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00955539

Contact: Niels Risum, M.D. +45 39978473
Contact: Thomas Fritz Hansen, M.D. +45 39773977

Gentofte University Hospital Recruiting
Hellerup, Denmark, 2900
Contact: Niels Risum, M.D.    +45 39978473   
Contact: Thomas Fritz Hansen, M.D.    +45 39773977   
Principal Investigator: Niels Risum, M.D.         
University Hospital Lund Recruiting
Lund, Sweden, 221 85
Contact: Rasmus Borgquist, MD, PhD    +46 70-4057350   
Principal Investigator: Rasmus Borgquist, MD, PhD         
Sponsors and Collaborators
University Hospital, Gentofte, Copenhagen
Lund University Hospital
Rigshospitalet, Denmark
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
  More Information

Responsible Party: Niels Risum, MD, University Hospital, Gentofte, Copenhagen Identifier: NCT00955539     History of Changes
Other Study ID Numbers: H-B-2009-057
Study First Received: August 7, 2009
Last Updated: October 4, 2011

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

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases processed this record on April 26, 2017