Survival of Patients With Primary Prophylactic ICD Indication - Full Text View

Sponsored by:	Biotronik GmbH & Co. KG
Information provided by:	Biotronik GmbH & Co. KG
ClinicalTrials.gov Identifier:	NCT00619593

Purpose

The MADIT-II trial has shown that patients with severely reduced left ventricular ejection fraction (LVEF) post myocardial infarction benefit from the implantable cardioverter-defibrillator (ICD). However, retrospective analyses of the MADIT-II data have revealed a significantly increased morbidity and mortality in patients with appropriate ICD therapy: Appropriate ICD therapy is associated with 3.3-fold increased all-cause mortality, and the risk of a first heart failure hospitalization is 90% higher after 1st appropriate ICD therapy. Hence, the 1st appropriate therapy might indicate the necessity and utility of further clinical diagnostics and therapy in these patients.

This trial is designed to (i) improve the knowledge of the group characteristics of patients suffering from 1st appropriate ICD therapy, (ii) but moreover to take additional therapeutic steps to reduce the mortality of this patient population.

Condition	Intervention	Phase
Death From Any Cause Sudden Cardiac Death Non-Sudden Cardiac Death	Other: Intensified diagnostic and treatment measures following 1st appropriate ICD therapy Other: Standard follow-up	Phase IV

MedlinePlus related topics: Cardiac Arrest Heart Failure

Drug Information available for: Creatinine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Survival of Patients With Primary Prophylactic ICD Indication, Provided With Intensified Care After 1st ICD Therapy

Further study details as provided by Biotronik GmbH & Co. KG:

Primary Outcome Measures:

Mortality [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Risk of 1st heart failure hospitalization [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	500
Study Start Date:	February 2008
Estimated Study Completion Date:	January 2012
Estimated Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
2: Active Comparator Standard follow-up in patients without appropriate ICD therapy	Other: Standard follow-up Standard follow-up in patients without appropriate ICD therapy
1: Experimental Following 1st appropriate ICD therapy, the patients have to be called to the clinic for intensified clinical diagnostics and, if necessary or useful, intensified therapy.	Other: Intensified diagnostic and treatment measures following 1st appropriate ICD therapy Assessment of general health status (weight, BP, NYHA) Laboratory tests (hemoglobin, Nt-proBNP, creatinine, GDF-15) Echocardiography (LVEF, LVEDD, mitral regurgitation) Non-invasive ischemia evaluation Coronary angiography (if indicated by ischemia evaluation) Upgrade to CRT, if indicated Ventricular ablation (if indicated: VT storm, slow VT, bundle branch reentry) 24 hrs ECG Holter (Heart rate variability) Further treatment (if applicable) Changes in ICD settings, or medication

Arms

Assigned Interventions

2: Active Comparator

Standard follow-up in patients without appropriate ICD therapy

Other: Standard follow-up

Standard follow-up in patients without appropriate ICD therapy

1: Experimental

Following 1st appropriate ICD therapy, the patients have to be called to the clinic for intensified clinical diagnostics and, if necessary or useful, intensified therapy.

Other: Intensified diagnostic and treatment measures following 1st appropriate ICD therapy

Assessment of general health status (weight, BP, NYHA)
Laboratory tests (hemoglobin, Nt-proBNP, creatinine, GDF-15)
Echocardiography (LVEF, LVEDD, mitral regurgitation)
Non-invasive ischemia evaluation
Coronary angiography (if indicated by ischemia evaluation)
Upgrade to CRT, if indicated
Ventricular ablation (if indicated: VT storm, slow VT, bundle branch reentry)
24 hrs ECG Holter (Heart rate variability)
Further treatment (if applicable)
Changes in ICD settings, or medication

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Indication for ICD implantation according to MADIT-II:
Myocardial infarction 40 days or more before entry
LVEF of 30% or less within 3 months before entry
Angiography within the preceding 6 months

Exclusion Criteria:

Patients with contraindication for ICD implantation
Conventional ICD indication (i.e. other than MADIT-II)
Myocardial infarction within the past 40 days
Coronary revascularisation within the preceding 3 months (i.e., if revasc. has been performed wait at least 3 months until enrolment)
NYHA functional class IV
Unexplained syncope within 3 years
Advanced cerebrovascular disease
Life expectancy very probably below 12 months
Pregnant or breast-feeding women
Age < 18 years
Patients who are already enrolled in another study (therapy/intervention phase)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00619593

Contacts

Contact: Petra Maier, Ph.D.

+49-9131-8924-7820

petra.maier@biotronik.com

Locations

Austria
3. Medizinische Abteilung mit Kardiologie, Wilhelminenspital der Stadt Wien	Recruiting
Wien, Austria, 1160
Principal Investigator: Gabriele Jakl-Kotauschek, Dr.
3. Medizinische Abteilung, Landesklinikum St. Pölten	Recruiting
St. Poelten, Austria, 3100
Principal Investigator: Harald Mayr, Dr.
Germany
Universitätsklinikum	Recruiting
Bonn, Germany, 53105
Principal Investigator: Jörg-Otto Schwab, Dr.
Krankenhaus St. Franziskus	Recruiting
Mönchengladbach, Germany, 41063
Principal Investigator: Istvan Szendey, Dr.
Hermann-Josef-Krankenhaus	Recruiting
Erkelenz, Germany, 41812
Principal Investigator: Klaus-Dieter Winter, Dr.
Latvia
Latvian Center of Cardiology - Arrhythmology, P. Stradins Clinical University Hospital	Recruiting
Riga, Latvia, 1002
Principal Investigator: Oskars Kalejs, Dr.
Slovakia
Kardiologická klinika, Národný ústav srdcových a cievnych chorôb	Recruiting
Bratislava, Slovakia, 833 48
Principal Investigator: Robert Hatala, Dr.

Sponsors and Collaborators

Biotronik GmbH & Co. KG

Investigators

Principal Investigator:

Robert Hatala, Prof. MUDr.

Národný ústav srdcových a cievnych chorôb, Kardiologická klinika, Pod Krásnou Hôrkou 1, 833 48 Bratislava, Slovakia

More Information

Responsible Party:	Biotronik GmbH & Co. KG ( Karsten Wallbrück )
Study ID Numbers:	TA079
Study First Received:	February 11, 2008
Last Updated:	September 26, 2008
ClinicalTrials.gov Identifier:	NCT00619593
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Biotronik GmbH & Co. KG:

Heart failure
Ventricular Fibrillation
Sudden cardiac death

Hospitalization due to heart failure
Implantable cardioverter-defibrillator
Risk of 1st heart failure hospitalization

Study placed in the following topic categories:

Death
Heart Failure
Heart Diseases
Death, Sudden

Paroxysmal ventricular fibrillation
Heart Arrest
Death, Sudden, Cardiac
Ventricular Fibrillation

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009