Heart FailureInContactNCT01200381
INvestigation on Routine Follow-up in CONgestive HearT FAilure Patients With Remotely Monitored Implanted Cardioverter Defibrillators (ICD) SysTems
A study testing Quarterly remote follow ups and remote monitoring, Quarterly remote follow ups + additional phone calls and remote monitoring and Quarterly in clinic follow ups and remote monitoring in people with Heart Failure, run by Abbott Medical Devices at 17 sites in Germany.
Trial summary
It's the aim of this study to analyze the benefit of personal patient / physician contacts in heart failure patients with remotely monitored implanted cardioverter defibrillators (ICD) or ICD with cardiac resynchronization therapy (CRT-D). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Quarterly remote follow ups and remote monitoring, Quarterly remote follow ups + additional phone calls and remote monitoring and Quarterly in clinic follow ups and remote monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 17 sitesGermany
- Study dates
- Feb 2010to Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Indication for implantation (new, boxchange, upgrade) of ICD/ CRT-D
- Written informed consent
- Ejection Fraction <= 35%
- New York Heart Association (NYHA) Class I-III
- Age >=18 and <=80 years
- In patient's home environment sufficient infrastructure (analog phone line or sufficient strength of GSM (Global System for Mobile communication) mobile phone network) for running a Merlin@home transmitter is available
Who cannot join
- Arterio ventricular (AV) Block III / AV Block II Type Mobitz
- Severe renal insufficiency
- Coronary angiology intervention within previous 3 months
- Myocardial infarction within previous month
- Life expectancy < 1 year
- Expected poor data quality / compliance
- Pregnancy
- Patient is already participating to another study with active therapy arm
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
Germany17 sites
SLK-Kliniken Heilbronn GmbH Klinikum am Plattenwald
Bad Friedrichshall, 74177
Asklepios Klinik Bad Oldesloe
Bad Oldesloe, 23843
Segeberger Kliniken GmbH
Bad Segeberg, 23795
Evangelisches Krankenhaus Bielefeld gGmbH
Bielefeld, 33617
Evangelisches Krankenhaus Kalk
Cologne, 51103
Universitätsklinikum Essen (AöR)
Essen, 45122
Herzkatheterlabor der Kardiologischen Praxis am Krankenhaus Neu-Bethlehem gGmbH
Göttingen, 37073
Asklepios Klinik St. Georg
Hamburg, 20099
Asklepios Klinik Barmbek
Hamburg, 22307
Klinikum Ingolstadt GmbH
Ingolstadt, 85049
Kardiologische Praxis - Partnergesellschaft
Ludwigsburg, 71634
Städtisches Klinikum Lüneburg gGmbH
Lüneburg, 21339
Marienhaus Klinikum St. Elisabeth-Krankenhaus
Neuwied, 56564
Praxis Dr. med. Balbach / Ruppert
Nürtingen, 72622
Kardiologische Gemeinschaftspraxis am Park Sanssouci
Potsdam, 14471
Klinikum Sindelfingen-Böblingen gGmbH
Sindelfingen, 71065
Marienhospital Stuttgart
Stuttgart, 70199
About this study
Official title: INvestigation on Routine Follow-up in CONgestive HearT FAilure Patients With Remotely Monitored ICD SysTems
It's the aim of this study to analyze the benefit of personal patient / physician contacts in heart failure patients with remotely monitored implanted cardioverter defibrillators (ICD) or ICD with cardiac resynchronization therapy (CRT-D).
The personal follow up (in clinic or phone calls) will be compared to completely automatic remote follow ups.
All patients will receive remote monitoring for automatic daily alarm checks and will undergo in clinic follow ups in 12 months intervals
- Conditions
- Heart Failure
- Being tested
- Quarterly remote follow ups and remote monitoring, Quarterly remote follow ups + additional phone calls and remote monitoring, Quarterly in clinic follow ups and remote monitoring
- Keywords
- ICD, CRTD, Remote care, Remote monitoring, Heart failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quarterly remote follow ups and remote monitoringOther
Quarterly remote follow ups and remote monitoring
Quarterly remote follow ups + additional phone calls and remote monitoringOther
Quarterly remote follow ups + additional phone calls and remote monitoring
Quarterly in clinic follow ups and remote monitoringOther
Quarterly in clinic follow ups and remote monitoring
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Automatic anonymous ICD/CRTD follow up (quarterly remote follow ups) Receives: Other: Quarterly remote follow ups and remote monitoring |
| Group B1 | Active comparator | Personal ICD/CRTD follow up (phone calls + quarterly remote follow ups) Receives: Other: Quarterly remote follow ups + additional phone calls and remote monitoring |
| Group B2 | Active comparator | Personal ICD/CRTD follow up (Quarterly visits) Receives: Other: Quarterly in clinic follow ups and remote monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of patients with worsened outcome in reference to Packer's "Heart Failure Clinical Composite Response"
Measured: 12 months (between 1 and 13 months post implant)
Secondary outcomes (7)
Mortality
Measured: 12 months (between 1 and 13 months post implant)
Heart failure hospitalizations
Measured: 12 months (between 1 and 13 months post implant)
Cardiovascular events
Measured: 12 months (between 1 and 13 months post implant)
Number of additional, unscheduled follow ups
Measured: 12 months (between 1 and 13 months post implant)
Number of follow ups with relevant findings
Measured: 12 months (between 1 and 13 months post implant)
Number of delivered / appropriate ICD therapies
Measured: 12 months (between 1 and 13 months post implant)
Quality of life (MLHFQ)
Measured: 12 months (between 1 and 13 months post implant)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2010 (estimated)
- Study startFeb 2010
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christian Weiss, Prof. Dr. med., Study chair, Städtisches Klinikum Lüneburg gGmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01200381
- Sponsor's protocol ID
- T94
- Acronym
- InContact
- Status last verified
- Feb 2019
- First submitted
- 10 Sep 2010
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Hansen C, Loges C, Seidl K, Eberhardt F, Troster H, Petrov K, Gronefeld G, Bramlage P, Birkenhauer F, Weiss C. INvestigation on Routine Follow-up in CONgestive HearT FAilure Patients with Remotely Monitored Implanted Cardioverter Defibrillators SysTems (InContact). BMC Cardiovasc Disord. 2018 Jun 28;18(1):131. doi: 10.1186/s12872-018-0864-7.
PubMed 29954340
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INvestigation on Routine Follow-up in CONgestive HearT FAilure Patients With Remotely Monitored ICD SysTems
- ClinicalTrials.gov ID
- NCT01200381
- Acronym / sponsor ID
- InContact / T94
- Conditions
- Heart Failure
- Keywords
- ICD, CRTD, Remote care, Remote monitoring, Heart failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 13 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It's the aim of this study to analyze the benefit of personal patient / physician contacts in heart failure patients with remotely monitored implanted cardioverter defibrillators (ICD) or ICD with cardiac resynchronization therapy (CRT-D).
The personal follow up (in clinic or phone calls) will be compared to completely automatic remote follow ups.
All patients will receive remote monitoring for automatic daily alarm checks and will undergo in clinic follow ups in 12 months intervals
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Other: Quarterly remote follow ups and remote monitoringAutomatic anonymous ICD/CRTD follow up (quarterly remote follow ups) |
| Group B1 | Active comparator | Other: Quarterly remote follow ups + additional phone calls and remote monitoringPersonal ICD/CRTD follow up (phone calls + quarterly remote follow ups) |
| Group B2 | Active comparator | Other: Quarterly in clinic follow ups and remote monitoringPersonal ICD/CRTD follow up (Quarterly visits) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Indication for implantation (new, boxchange, upgrade) of ICD/ CRT-D
- Written informed consent
- Ejection Fraction <= 35%
- New York Heart Association (NYHA) Class I-III
- Age >=18 and <=80 years
Key exclusion criteria (8 listed)
- Arterio ventricular (AV) Block III / AV Block II Type Mobitz
- Severe renal insufficiency
- Coronary angiology intervention within previous 3 months
- Myocardial infarction within previous month
- Life expectancy < 1 year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quarterly remote follow ups and remote monitoringQuarterly remote follow ups and remote monitoring | Other | Group A |
| Quarterly remote follow ups + additional phone calls and remote monitoringQuarterly remote follow ups + additional phone calls and remote monitoring | Other | Group B1 |
| Quarterly in clinic follow ups and remote monitoringQuarterly in clinic follow ups and remote monitoring | Other | Group B2 |
Primary outcome
Amount of patients with worsened outcome in reference to Packer's "Heart Failure Clinical Composite Response"
Time frame: 12 months (between 1 and 13 months post implant)
7 secondary outcomes
Mortality
Time frame: 12 months (between 1 and 13 months post implant)
Heart failure hospitalizations
Time frame: 12 months (between 1 and 13 months post implant)
Cardiovascular events
Time frame: 12 months (between 1 and 13 months post implant)
Number of additional, unscheduled follow ups
Time frame: 12 months (between 1 and 13 months post implant)
Number of follow ups with relevant findings
Time frame: 12 months (between 1 and 13 months post implant)
Number of delivered / appropriate ICD therapies
Time frame: 12 months (between 1 and 13 months post implant)
Quality of life (MLHFQ)
Time frame: 12 months (between 1 and 13 months post implant)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
- Derived from this study: PubMed 29954340Hansen C, Loges C, Seidl K, Eberhardt F, Troster H, Petrov K, Gronefeld G, Bramlage P, Birkenhauer F, Weiss C. INvestigation on Routine Follow-up in CONgestive HearT FAilure Patients with Remotely Monitored Implanted Cardioverter Defibrillators SysTems (InContact). BMC Cardiovasc Disord. 2018 Jun 28;18(1):131. doi: 10.1186/s12872-018-0864-7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Weiss, Prof. Dr. med. study chair
Städtisches Klinikum Lüneburg gGmbH
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quarterly remote follow ups and remote monitoring, Quarterly remote follow ups + additional phone calls and remote monitoring and Quarterly in clinic follow ups and remote monitoring in people with Heart Failure, run by Abbott Medical Devices at 17 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of patients with worsened outcome in reference to Packer's "Heart Failure Clinical Composite Response" (time frame: 12 months (between 1 and 13 months post implant)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01200381, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2019.