Viability and Cardiac Resynchronization Therapy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by University Hospital, Gentofte, Copenhagen.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Lund University Hospital
Rigshospitalet, Denmark
Information provided by (Responsible Party):
Niels Risum, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier:
NCT00955539
First received: August 7, 2009
Last updated: October 4, 2011
Last verified: October 2011

August 7, 2009
October 4, 2011
August 2009
December 2012   (final data collection date for primary outcome measure)
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) ] [ Designated as safety issue: No ]
Responders:Echocardiographic:>/= 10% increase in LVEF Clinical: >/= 25% increase in 6-min walk test or >/= 1 in NYHA-class [ Time Frame: 4 and 8 months, ( follow up- 2 years) ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00955539 on ClinicalTrials.gov Archive Site
  • 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) ] [ Designated as safety issue: No ]
  • Clinical: >/= 25% increase in 6-min walk test or >/= 1 reduction in NYHA-class [ Time Frame: 4 and 8 months (follow-up 2 years) ] [ Designated as safety issue: No ]
LVESV, LVEDV, CO, MLHFQ ProBNP Others: t-wave modulation all-cause mortality, cardiac death, hospitalization [ Time Frame: 4 and 8 months (follow-up after 2 years) ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Viability and Cardiac Resynchronization Therapy
The Importance of Viability for Response to Cardiac Resynchronization Therapy

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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
  • Heart Failure
  • Ischemic Cardiomyopathy
  • 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.
  • 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.
  • Active Comparator: CRT group 1
    Intervention: Device: AV-optimization followed by AV- and VV-optimization
  • Active Comparator: CRT group 2
    Intervention: Device: AV- and VV-optimization followed by AV-optimization only.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
June 2013
December 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Niels Risum, M.D. +45 39978473 nieris01@geh.regionh.dk
Contact: Thomas Fritz Hansen, M.D. +45 39773977 THHAN@geh.regionh.dk
Denmark,   Sweden
 
NCT00955539
H-B-2009-057
Yes
Niels Risum, University Hospital, Gentofte, Copenhagen
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
University Hospital, Gentofte, Copenhagen
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP