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

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

ChemIDplus related topics:

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

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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
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 October 17, 2008

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