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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00538356




Registration number
NCT00538356
Ethics application status
Date submitted
1/10/2007
Date registered
2/10/2007
Date last updated
23/12/2014

Titles & IDs
Public title
Influence of Home Monitoring on the Clinical Status of Heart Failure Patients With an Impaired Left Ventricular Function
Scientific title
IN-TIME: Influence of Home Monitoring on the Clinical Status of Heart Failure Patients
Secondary ID [1] 0 0
There is no secondary ID
Secondary ID [2] 0 0
HS042
Universal Trial Number (UTN)
Trial acronym
IN-TIME
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ventricular Fibrillation 0 0
Ventricular Tachycardia 0 0
Congestive Heart Failure 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - ICD or CRT-D with Home Monitoring feature deactivated
Treatment: Devices - ICD or CRT-D with Home Monitoring feature activated

Experimental: Home Monitoring - ICD or CRT-D with Home Monitoring feature activated Home Monitoring data will be analyzed regularly and patients will be contacted and scheduled for additional follow-up after predefined events

Active comparator: Control - ICD or CRT-D with Home Monitoring feature deactivated Patients will be treated as per standard of care in each participating clinic


Treatment: Devices: ICD or CRT-D with Home Monitoring feature deactivated
Standard care

Treatment: Devices: ICD or CRT-D with Home Monitoring feature activated
Standard care + patient management by Home Monitoring
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Composite Score of death, hospitalization for heart failure, NYHA class and global assessment (Packer Score)
Timepoint [1] 0 0
12 months
Secondary outcome [1] 0 0
Rehospitalizations due to worsening heart failure; Correlation of Home Monitoring values with the clinical status; Incidence and reasons for Home Monitoring based interventions; Home Monitoring workflow analysis
Timepoint [1] 0 0
12 months

Eligibility
Key inclusion criteria
* Indication for single chamber ICD, dual chamber ICD or CRT-D
* Chronic heart failure (= 3 months)
* NYHA Class II or III for 1 month prior to screening
* LVEF = 35% within 3 months prior to screening
* Indication for therapy with diuretics
* Patient informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Uncontrolled hypertension
* NYHA class I or IV
* Permanent atrial fibrillation
* Life expectancy < 1 year
* Restrictive, infiltrative or hypertrophic cardiomyopathy, constrictive pericarditis, acute myocarditis
* Severe mitral regurgitation
* Symptomatic aortic stenosis
* Tricuspid valve replacement
* Known drug or alcohol abuse
* Expected non-compliance
* Pregnancy
* Participation in another telemonitoring concept
* Participation in another study

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
1/07/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2013
Sample size
Target
Accrual to date
Final
720
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Sydney Adventist Hospital - Wahroonga
Recruitment postcode(s) [1] 0 0
2076 - Wahroonga
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Innsbruck
Country [2] 0 0
Czech Republic
State/province [2] 0 0
Praha
Country [3] 0 0
Denmark
State/province [3] 0 0
Aalborg
Country [4] 0 0
Denmark
State/province [4] 0 0
Hellerup
Country [5] 0 0
Denmark
State/province [5] 0 0
Odense
Country [6] 0 0
Denmark
State/province [6] 0 0
Århus N
Country [7] 0 0
Germany
State/province [7] 0 0
Bad Berka
Country [8] 0 0
Germany
State/province [8] 0 0
Bad Neustadt
Country [9] 0 0
Germany
State/province [9] 0 0
Bad Segeberg
Country [10] 0 0
Germany
State/province [10] 0 0
Berlin
Country [11] 0 0
Germany
State/province [11] 0 0
Bielefeld
Country [12] 0 0
Germany
State/province [12] 0 0
Bonn
Country [13] 0 0
Germany
State/province [13] 0 0
Coburg
Country [14] 0 0
Germany
State/province [14] 0 0
Detmold
Country [15] 0 0
Germany
State/province [15] 0 0
Essen
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
Homburg/Saar
Country [19] 0 0
Germany
State/province [19] 0 0
Leipzig
Country [20] 0 0
Germany
State/province [20] 0 0
Lübeck
Country [21] 0 0
Germany
State/province [21] 0 0
Lünen
Country [22] 0 0
Germany
State/province [22] 0 0
Munich - Schwabing
Country [23] 0 0
Germany
State/province [23] 0 0
München
Country [24] 0 0
Germany
State/province [24] 0 0
Nordhausen
Country [25] 0 0
Germany
State/province [25] 0 0
Paderborn
Country [26] 0 0
Germany
State/province [26] 0 0
Pirna
Country [27] 0 0
Israel
State/province [27] 0 0
Ashkelon
Country [28] 0 0
Israel
State/province [28] 0 0
Petach-Tikva
Country [29] 0 0
Israel
State/province [29] 0 0
Tel-Hashomer
Country [30] 0 0
Latvia
State/province [30] 0 0
Riga

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gerhard Hindricks, Prof. Dr.
Address 0 0
Herzzentrum Leipzig, Germany
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00538356