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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00619593




Registration number
NCT00619593
Ethics application status
Date submitted
11/02/2008
Date registered
21/02/2008
Date last updated
12/01/2015

Titles & IDs
Public title
Survival of Patients With Primary Prophylactic ICD Indication
Scientific title
Survival of Patients With Primary Prophylactic ICD Indication, Provided With Intensified Care After 1st ICD Therapy
Secondary ID [1] 0 0
TA079
Universal Trial Number (UTN)
Trial acronym
SPIRIT-ICD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Primary Prevention 0 0
Tachycardia, Ventricular 0 0
Sudden Cardiac Death 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Intensified diagnostic and treatment measures following 1st appropriate ICD therapy
Other interventions - Standard follow-up

Active comparator: 2 - Standard follow-up in patients without appropriate ICD therapy

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 interventions: 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 interventions: Standard follow-up
Standard follow-up in patients without appropriate ICD therapy
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mortality
Timepoint [1] 0 0
12 months
Secondary outcome [1] 0 0
Sudden cardiac death
Timepoint [1] 0 0
12 months
Secondary outcome [2] 0 0
Non-sudden cardiac death
Timepoint [2] 0 0
12 months
Secondary outcome [3] 0 0
Risk of 1st heart failure hospitalization
Timepoint [3] 0 0
12 months
Secondary outcome [4] 0 0
No. of VT Storms (> 3 VT/24h)
Timepoint [4] 0 0
12 months
Secondary outcome [5] 0 0
No. of delivered ICD therapies
Timepoint [5] 0 0
12 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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)

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2014
Sample size
Target
Accrual to date
Final
504
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Linz
Country [2] 0 0
Austria
State/province [2] 0 0
St. Poelten
Country [3] 0 0
Austria
State/province [3] 0 0
Wien
Country [4] 0 0
Czech Republic
State/province [4] 0 0
Brno
Country [5] 0 0
Czech Republic
State/province [5] 0 0
Olomouc
Country [6] 0 0
Czech Republic
State/province [6] 0 0
Praha
Country [7] 0 0
Germany
State/province [7] 0 0
Aachen
Country [8] 0 0
Germany
State/province [8] 0 0
Bad Neustadt
Country [9] 0 0
Germany
State/province [9] 0 0
Bielefeld
Country [10] 0 0
Germany
State/province [10] 0 0
Bonn
Country [11] 0 0
Germany
State/province [11] 0 0
Detmold
Country [12] 0 0
Germany
State/province [12] 0 0
Dortmund
Country [13] 0 0
Germany
State/province [13] 0 0
Dresden
Country [14] 0 0
Germany
State/province [14] 0 0
Düsseldorf
Country [15] 0 0
Germany
State/province [15] 0 0
Erkelenz
Country [16] 0 0
Germany
State/province [16] 0 0
Gießen
Country [17] 0 0
Germany
State/province [17] 0 0
Hannover
Country [18] 0 0
Germany
State/province [18] 0 0
Landshut
Country [19] 0 0
Germany
State/province [19] 0 0
Mönchengladbach
Country [20] 0 0
Germany
State/province [20] 0 0
Paderborn
Country [21] 0 0
Germany
State/province [21] 0 0
Rostock
Country [22] 0 0
Germany
State/province [22] 0 0
Unna
Country [23] 0 0
Hungary
State/province [23] 0 0
Budapest
Country [24] 0 0
Hungary
State/province [24] 0 0
Debrecen
Country [25] 0 0
Israel
State/province [25] 0 0
Tel Hashomer
Country [26] 0 0
Latvia
State/province [26] 0 0
Riga
Country [27] 0 0
New Zealand
State/province [27] 0 0
Hamilton
Country [28] 0 0
Poland
State/province [28] 0 0
Lodz
Country [29] 0 0
Poland
State/province [29] 0 0
Warzawa
Country [30] 0 0
Slovakia
State/province [30] 0 0
Banska Bystrica
Country [31] 0 0
Slovakia
State/province [31] 0 0
Bratislava
Country [32] 0 0
Slovakia
State/province [32] 0 0
Kosice
Country [33] 0 0
Spain
State/province [33] 0 0
Valencia
Country [34] 0 0
Switzerland
State/province [34] 0 0
Basel

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Biotronik SE & Co. KG
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00619593
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Robert Hatala, Prof. MUDr.
Address 0 0
Národný ústav srdcových a cievnych chorôb, Kardiologická klinika, Pod Krásnou Hôrkou 1, 833 48 Bratislava, Slovakia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00619593