Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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) ] [ Designated as safety issue: No ]

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) ] [ 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 ]

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  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 ClinicalTrials.gov identifier: 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
  More Information

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
Study First Received: August 7, 2009
Last Updated: October 4, 2011
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: The Danish National Committee on Biomedical Research Ethics

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

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

ClinicalTrials.gov processed this record on November 25, 2014