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Viability and Cardiac Resynchronization Therapy

The Importance of Viability for Response to Cardiac Resynchronization Therapy

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00955539
Enrollment
100
Registered
2009-08-10
Start date
2009-08-31
Completion date
2013-06-30
Last updated
2011-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure, Ischemic Cardiomyopathy

Keywords

Heart Failure, Cardiac resynchronization therapy, Optimization, Viability, Mechanical dyssynchrony

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 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.

Interventions

DEVICEAV-optimization followed by AV- and VV-optimization

Patients are AV-optimized the first 4 months,then AV- and VV-optimized the next 4 months.

DEVICEAV- 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.

Sponsors

Lund University Hospital
CollaboratorOTHER
Rigshospitalet, Denmark
CollaboratorOTHER
University Hospital, Gentofte, Copenhagen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
Responders:Echocardiographic:>/= 10% increase in Left ventricular ejection fraction (LVEF) or >/= 15 % reduction in left ventricular end-systolic volume (LVESV)4 and 8 months, ( follow up- 2 years)

Secondary

MeasureTime frame
LVESV, LVEDV, Cardiac output (CO), Minnesota Living with Heart Failure Questionnaire (MLHFQ) ProBNP Others: t-wave modulation all-cause mortality, cardiac death, hospitalization4 and 8 months (follow-up after 2 years)
Clinical: >/= 25% increase in 6-min walk test or >/= 1 reduction in NYHA-class4 and 8 months (follow-up 2 years)

Countries

Denmark, Sweden

Contacts

Primary ContactNiels Risum, M.D.
nieris01@geh.regionh.dk+45 39978473
Backup ContactThomas Fritz Hansen, M.D.
THHAN@geh.regionh.dk+45 39773977

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026