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Viability and Cardiac Resynchronization Therapy

Primary Purpose

Heart Failure, Ischemic Cardiomyopathy

Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
AV-optimization followed by AV- and VV-optimization
AV- and VV-optimization followed by AV-optimization only.
Sponsored by
University Hospital, Gentofte, Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Heart Failure, Cardiac resynchronization therapy, Optimization, Viability, Mechanical dyssynchrony

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Gentofte University HospitalRecruiting
  • University Hospital LundRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

CRT group 1

CRT group 2

Arm Description

Outcomes

Primary Outcome Measures

Responders:Echocardiographic:>/= 10% increase in Left ventricular ejection fraction (LVEF) or >/= 15 % reduction in left ventricular end-systolic volume (LVESV)

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
Clinical: >/= 25% increase in 6-min walk test or >/= 1 reduction in NYHA-class

Full Information

First Posted
August 7, 2009
Last Updated
October 4, 2011
Sponsor
University Hospital, Gentofte, Copenhagen
Collaborators
Lund University Hospital, Rigshospitalet, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT00955539
Brief Title
Viability and Cardiac Resynchronization Therapy
Official Title
The Importance of Viability for Response to Cardiac Resynchronization Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Unknown status
Study Start Date
August 2009 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
June 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Gentofte, Copenhagen
Collaborators
Lund University Hospital, Rigshospitalet, Denmark

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Ischemic Cardiomyopathy
Keywords
Heart Failure, Cardiac resynchronization therapy, Optimization, Viability, Mechanical dyssynchrony

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CRT group 1
Arm Type
Active Comparator
Arm Title
CRT group 2
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
AV-optimization followed by AV- and VV-optimization
Intervention Description
Patients are AV-optimized the first 4 months,then AV- and VV-optimized the next 4 months.
Intervention Type
Device
Intervention Name(s)
AV- and VV-optimization followed by AV-optimization only.
Intervention Description
Patients are AV- and VV-optimized the first 4 months,then AV-optimized the next 4 months.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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)
Title
Clinical: >/= 25% increase in 6-min walk test or >/= 1 reduction in NYHA-class
Time Frame
4 and 8 months (follow-up 2 years)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Niels Risum, M.D.
Phone
+45 39978473
Email
nieris01@geh.regionh.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas Fritz Hansen, M.D.
Phone
+45 39773977
Email
THHAN@geh.regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Niels Risum, M.D.
Organizational Affiliation
University Hospital Gentofte, Department of cardiology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thomas Fritz Hansen, M.D.
Organizational Affiliation
University Hospital Gentofte, department of cardiology
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Peter Søgaard, M.D., DMSc.
Organizational Affiliation
Gentofte University Hospital, department of cardiology
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Rasmus Borgquist, MD, PhD
Organizational Affiliation
University Hospital Lund
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Niels E Bruun, MD, DMSc
Organizational Affiliation
Gentofte University Hospital, department of cardiology
Official's Role
Study Chair
Facility Information:
Facility Name
Gentofte University Hospital
City
Hellerup
ZIP/Postal Code
2900
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Niels Risum, M.D.
Phone
+45 39978473
Email
nieris01@geh.regionh.dk
First Name & Middle Initial & Last Name & Degree
Thomas Fritz Hansen, M.D.
Phone
+45 39773977
Email
THHAN@geh.regionh.dk
First Name & Middle Initial & Last Name & Degree
Niels Risum, M.D.
Facility Name
University Hospital Lund
City
Lund
ZIP/Postal Code
221 85
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rasmus Borgquist, MD, PhD
Phone
+46 70-4057350
Email
rasmus.borgquist@med.lu.se
First Name & Middle Initial & Last Name & Degree
Rasmus Borgquist, MD, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
16360042
Citation
Bax JJ, Abraham T, Barold SS, Breithardt OA, Fung JW, Garrigue S, Gorcsan J 3rd, Hayes DL, Kass DA, Knuuti J, Leclercq C, Linde C, Mark DB, Monaghan MJ, Nihoyannopoulos P, Schalij MJ, Stellbrink C, Yu CM. Cardiac resynchronization therapy: Part 1--issues before device implantation. J Am Coll Cardiol. 2005 Dec 20;46(12):2153-67. doi: 10.1016/j.jacc.2005.09.019.
Results Reference
background
PubMed Identifier
12379577
Citation
Sogaard P, Egeblad H, Pedersen AK, Kim WY, Kristensen BO, Hansen PS, Mortensen PT. Sequential versus simultaneous biventricular resynchronization for severe heart failure: evaluation by tissue Doppler imaging. Circulation. 2002 Oct 15;106(16):2078-84. doi: 10.1161/01.cir.0000034512.90874.8e.
Results Reference
background
PubMed Identifier
16476852
Citation
Bleeker GB, Kaandorp TA, Lamb HJ, Boersma E, Steendijk P, de Roos A, van der Wall EE, Schalij MJ, Bax JJ. Effect of posterolateral scar tissue on clinical and echocardiographic improvement after cardiac resynchronization therapy. Circulation. 2006 Feb 21;113(7):969-76. doi: 10.1161/CIRCULATIONAHA.105.543678. Epub 2006 Feb 13.
Results Reference
background
PubMed Identifier
15753115
Citation
Cleland JG, Daubert JC, Erdmann E, Freemantle N, Gras D, Kappenberger L, Tavazzi L; Cardiac Resynchronization-Heart Failure (CARE-HF) Study Investigators. The effect of cardiac resynchronization on morbidity and mortality in heart failure. N Engl J Med. 2005 Apr 14;352(15):1539-49. doi: 10.1056/NEJMoa050496. Epub 2005 Mar 7.
Results Reference
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Viability and Cardiac Resynchronization Therapy

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