Survival of Patients With Primary Prophylactic ICD Indication (SPIRIT-ICD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biotronik SE & Co. KG
ClinicalTrials.gov Identifier:
NCT00619593
First received: February 11, 2008
Last updated: August 20, 2014
Last verified: February 2014
  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
Primary Prevention
Tachycardia, Ventricular
Sudden Cardiac Death
Other: Intensified diagnostic and treatment measures following 1st appropriate ICD therapy
Other: Standard follow-up
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Survival of Patients With Primary Prophylactic ICD Indication, Provided With Intensified Care After 1st ICD Therapy

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Mortality [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sudden cardiac death [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Non-sudden cardiac death [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Risk of 1st heart failure hospitalization [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • No. of VT Storms (> 3 VT/24h) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • No. of delivered ICD therapies [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 504
Study Start Date: February 2008
Study Completion Date: July 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 2
Standard follow-up in patients without appropriate ICD therapy
Other: Standard follow-up
Standard follow-up in patients without appropriate ICD therapy
Other Name: Standard follow-up
Experimental: 1
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
Other Name: Intensified diagnostic and treatment measures

  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 30 days or more before implantation
    • LVEF of 30% or less within 3 months before implantation
  • Angiography within the preceding 12 months
  • The patient is willing and able to comply with the clinical investigation plan and has provided written informed consent

Exclusion Criteria:

  • Patients with contraindication for ICD implantation
  • Conventional ICD indication (i.e. other than MADIT-II)
  • Myocardial infarction within the past 30 days
  • Coronary revascularisation within the preceding 3 months (i.e., if revascularization has been performed wait at least 3 months until enrolment, given that no appropriate/ inappropriate ICD therapy has occured)
  • 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
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: NCT00619593

  Hide Study Locations
Locations
Austria
A.ö. Krankenhaus der Stadt Linz
Linz, Austria, 4020
Landesklinikum St. Pölten
St. Poelten, Austria, 3100
Wilhelminenspital der Stadt Wien
Wien, Austria, 1160
Czech Republic
Fakultni nemocnice u Svety Anny
Brno, Czech Republic, 65691
Brno Bohunice
Brno, Czech Republic, 62500
FN Olomouc, Inerni klinika
Olomouc, Czech Republic, 77520
Institute of clinical and experimental medicine
Praha, Czech Republic, 1421
Online 24 S.R.O.
Praha, Czech Republic, 12000
Germany
University Hospital RWTH Aachen
Aachen, Germany, 52074
Herz- und Gefäss-Klinik GmbH Bad Neustadt
Bad Neustadt, Germany, 97616
Klinikum Bielefeld
Bielefeld, Germany, 33604
Universitätsklinikum Bonn
Bonn, Germany, 53105
St. Marien Hospital
Bonn, Germany, 53115
Klinikum Detmold Lippe
Detmold, Germany, 32756
Klinikum Mitte
Dortmund, Germany, 44137
Städtisches Klinikum Dresden-Friedrichstadt
Dresden, Germany, 01067
Evangelisches Krankenhaus
Düsseldorf, Germany, 40217
Hermann-Josef-Krankenhaus
Erkelenz, Germany, 41812
Justus Liebig Universität Gießen
Gießen, Germany, 35392
Medizinische Hochschule Hannover
Hannover, Germany, 30625
Krankenhaus Landshut-Achdorf
Landshut, Germany, 84034
Krankenhaus St. Franziskus
Mönchengladbach, Germany, 41063
St. Vincenz Krankenhaus
Paderborn, Germany, 33098
University Hospital Rostock
Rostock, Germany, 18055
Katharinenhospital
Unna, Germany, 59423
Hungary
Semmelweis University
Budapest, Hungary, 1122
The University of Medicine Debrecen
Debrecen, Hungary, 4012
Israel
Chaim Sheba Medical Center
Tel Hashomer, Israel, 52621
Latvia
Latvian Center of Cardiology
Riga, Latvia, 1002
New Zealand
Health Waikato, Cardiology Department
Hamilton, New Zealand
Poland
MULTI-MED PLUS Spolka z o.o
Lodz, Poland, 95336
Instytut Kardiologii
Warzawa, Poland, 04-628
Slovakia
Ssusch
Banska Bystrica, Slovakia, 97401
Kardiologická klinika
Bratislava, Slovakia, 833 48
VUSCH East Slovak Cardiology Institute
Kosice, Slovakia, 04001
Spain
H. Univ. La Fe
Valencia, Spain, 46009
Switzerland
Universitätsspital Basel
Basel, Switzerland, 4031
Sponsors and Collaborators
Biotronik SE & 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

No publications provided

Responsible Party: Biotronik SE & Co. KG
ClinicalTrials.gov Identifier: NCT00619593     History of Changes
Other Study ID Numbers: TA079
Study First Received: February 11, 2008
Last Updated: August 20, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Biotronik SE & Co. KG:
Heart failure
Ventricular Fibrillation
Sudden cardiac death
Hospitalization due to heart failure
Implantable cardioverter-defibrillator
Risk of 1st heart failure hospitalization

Additional relevant MeSH terms:
Tachycardia
Death, Sudden, Cardiac
Tachycardia, Ventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Heart Arrest
Death, Sudden
Death

ClinicalTrials.gov processed this record on October 19, 2014