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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Re-hospitalizations or deaths by worsening heart failure are often preceded by distinct
trends of clinical parameters such as atrial or ventricular arrhythmia, activity, heart rate
variability, or ventricular ectopy. The Home Monitoring™ capability offered by BIOTRONIK
active implants has the potential to detect some of these trends early and thus to offer the
possibility to intervene in time for prevention of fatal worsening of heart failure.

To investigate the predictive value of Home Monitoring parameters, patients with symptomatic
heart failure and reduced ejection fraction receiving an implantable
cardioverter-defibrillator (ICD) or an ICD in combination with cardiac resynchronization
therapy (CRT-D) will be randomized between prospective patient management by Home Monitoring
analysis or standard care. The influence of Home Monitoring on the clinical status of heart
failure patients will be assessed.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00538356
Trial related presentations / publications
Arya A, Block M, Kautzner J, Lewalter T, Mortel H, Sack S, Schumacher B, Sogaard P, Taborsky M, Husser D, Hindricks G; IN-TIME investigators. Influence of Home Monitoring on the clinical status of heart failure patients: Design and rationale of the IN-TIME study. Eur J Heart Fail. 2008 Nov;10(11):1143-8. doi: 10.1016/j.ejheart.2008.08.004. Epub 2008 Sep 19.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00538356