Congestive Heart FailureREMOTE-CIEDNCT01691586
Patient Perspective on Remote Monitoring of Cardiovascular Implantable Electronic Devices
A study testing Remote patient monitoring and In-Clinic check-ups in people with Congestive Heart Failure, run by UMC Utrecht at 1 site in Netherlands.
Trial summary
A relatively new and promising development in the area of cardiovascular implantable electronic device therapy is remote patient monitoring (RPM). RPM systems can interrogate the device automatically and send the data from the patients' home to the physician, thereby reducing in-clinic follow-ups. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Congestive Heart Failure
- What is being tested?
- Remote patient monitoring and In-Clinic check-ups
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteNetherlands
- Study dates
- 13 Apr 2013to 15 Jan 2018
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- first time ICD/CRT-D implanted at one of the participating centers
- left ventricular ejection fraction <35%
- NYHA functional class II or III symptoms
- ICD/CRT-D device compatible with the LATITUDE(r) RPM system from Boston Scientific
Who cannot join
- On the waiting list for heart transplantation
- History of psychiatric illness others than affective/anxiety disorders
- Cognitive impairments
- Insufficient knowledge of the language to fill in the questionnaires
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Remote Monitoring of Heart Failure Patients With Cardiovascular Implantable Electronic Device: The Patient Perspective
A relatively new and promising development in the area of cardiovascular implantable electronic device therapy is remote patient monitoring (RPM). RPM systems can interrogate the device automatically and send the data from the patients' home to the physician, thereby reducing in-clinic follow-ups.
The purpose of this study is to evaluate the effect of RPM + in-clinic follow-up versus in-clinic follow-up only on patient-reported health status and device-acceptance after implantation with an implantable cardioverter defibrillator (ICD) or cardiac resynchronization defibrillator (CRT-D).
Secondary objectives are (1) to identify subgroups of patients who prefer RPM over in-clinic visits or vice versa due to specific clinical and psychological factors and (2) To investigate the cost-effectiveness of RPM + in-clinic follow-up compared to in-clinic follow-up only.
- Conditions
- Congestive Heart Failure
- Being tested
- Remote patient monitoring, In-Clinic check-ups
- Keywords
- implantable defibrillators, remote patient monitoring, patient-reported outcomes, cost-effectiveness
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote patient monitoringDevice
Also called Boston Scientific LATITUDE system
Remote monitoring of ICD and heart failure data
In-Clinic check-upsOther
Calender-based In-Clinic ICD check-up
| Study group | Role | What they receive |
|---|---|---|
| Remote patient management | Experimental | Remote patient management system + yearly in-clinic follow-up Receives: Device: Remote patient monitoring; Other: In-Clinic check-ups |
| In-Clinic follow-up | Other | In-clinic follow-up according to standard practice (every 3-6 months) Receives: Other: In-Clinic check-ups |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-reported health status
23-item Kansas City Cardiomyopathy Questionnaire (KCCQ)
Measured: 24 months
Patient-reported device acceptance
12-item Florida Patient Acceptance Scale (FPAS)
Measured: 24 months
Secondary outcomes (2)
Patient-reported satisfaction with care
- Visual Analogue Scale ranging from 0-100 (with higher score representing more satisfaction with care)
- 26-item self-made questionnaire to assess satisfaction with RPM
Measured: 24 months
Cost-effectiveness
Data regarding health care utilization is gathered from hospitals and patients.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2012 (estimated)
- Study start13 Apr 2013
- Primary completion15 Jan 2018
- Study completion15 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation, Tilburg University, Erasmus Medical Center
- Responsible party
- Principal investigator, M. Meine, UMC Utrecht
- Investigators
- Mathias Meine, MD, PhD, Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01691586
- Sponsor's protocol ID
- UMCU.DHL.001
- Acronym
- REMOTE-CIED
- Status last verified
- Jun 2018
- First submitted
- 20 Sep 2012
- Last updated
- 8 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
de Graaf G, Timmermans I, Meine M, Alings M, Pedersen SS, Mabo P, Zitron E, Redekop K, Versteeg H. Economic evaluation of remote monitoring of patients with an implantable cardiac defibrillator (REMOTE-CIED study). J Telemed Telecare. 2024 Aug;30(7):1173-1185. doi: 10.1177/1357633X221129176. Epub 2022 Oct 17.
PubMed 36245363Chiu CSL, Timmermans I, Versteeg H, Zitron E, Mabo P, Pedersen SS, Meine M; REMOTE-CIED Trial Investigators. Effect of remote monitoring on clinical outcomes in European heart failure patients with an implantable cardioverter-defibrillator: secondary results of the REMOTE-CIED randomized trial. Europace. 2022 Feb 2;24(2):256-267. doi: 10.1093/europace/euab221.
PubMed 34410384Versteeg H, Timmermans I, Widdershoven J, Kimman GJ, Prevot S, Rauwolf T, Scholten MF, Zitron E, Mabo P, Denollet J, Pedersen SS, Meine M. Effect of remote monitoring on patient-reported outcomes in European heart failure patients with an implantable cardioverter-defibrillator: primary results of the REMOTE-CIED randomized trial. Europace. 2019 Sep 1;21(9):1360-1368. doi: 10.1093/europace/euz140.
PubMed 31168604Timmermans I, Meine M, Szendey I, Aring J, Romero Roldan J, van Erven L, Kahlert P, Zitron E, Mabo P, Denollet J, Versteeg H. Remote monitoring of implantable cardioverter defibrillators: Patient experiences and preferences for follow-up. Pacing Clin Electrophysiol. 2019 Feb;42(2):120-129. doi: 10.1111/pace.13574. Epub 2019 Jan 2.
PubMed 30536931Timmermans I, Versteeg H, Meine M, Pedersen SS, Denollet J. Illness perceptions in patients with heart failure and an implantable cardioverter defibrillator: Dimensional structure, validity, and correlates of the brief illness perception questionnaire in Dutch, French and German patients. J Psychosom Res. 2017 Jun;97:1-8. doi: 10.1016/j.jpsychores.2017.03.014. Epub 2017 Mar 23.
PubMed 28606488
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Monitoring of Heart Failure Patients With Cardiovascular Implantable Electronic Device: The Patient Perspective
- ClinicalTrials.gov ID
- NCT01691586
- Acronym / sponsor ID
- REMOTE-CIED / UMCU.DHL.001
- Conditions
- Congestive Heart Failure
- Keywords
- implantable defibrillators, remote patient monitoring, patient-reported outcomes, cost-effectiveness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation, Tilburg University, Erasmus Medical Center
- Study start
- 13 Apr 2013 (actual)
- Primary completion
- 15 Jan 2018 (actual)
- Study completion
- 15 Jan 2018 (actual)
- First posted
- 24 Sep 2012 (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.
A relatively new and promising development in the area of cardiovascular implantable electronic device therapy is remote patient monitoring (RPM). RPM systems can interrogate the device automatically and send the data from the patients' home to the physician, thereby reducing in-clinic follow-ups.
The purpose of this study is to evaluate the effect of RPM + in-clinic follow-up versus in-clinic follow-up only on patient-reported health status and device-acceptance after implantation with an implantable cardioverter defibrillator (ICD) or cardiac resynchronization defibrillator (CRT-D).
Secondary objectives are (1) to identify subgroups of patients who prefer RPM over in-clinic visits or vice versa due to specific clinical and psychological factors and (2) To investigate the cost-effectiveness of RPM + in-clinic follow-up compared to in-clinic follow-up only.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remote patient management | Experimental | Device: Remote patient monitoring, Other: In-Clinic check-upsRemote patient management system + yearly in-clinic follow-up |
| In-Clinic follow-up | Other | Other: In-Clinic check-upsIn-clinic follow-up according to standard practice (every 3-6 months) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- first time ICD/CRT-D implanted at one of the participating centers
- left ventricular ejection fraction <35%
- NYHA functional class II or III symptoms
- ICD/CRT-D device compatible with the LATITUDE(r) RPM system from Boston Scientific
Key exclusion criteria (4 listed)
- On the waiting list for heart transplantation
- History of psychiatric illness others than affective/anxiety disorders
- Cognitive impairments
- Insufficient knowledge of the language to fill in the questionnaires
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 |
|---|---|---|
| Remote patient monitoringAlso: Boston Scientific LATITUDE systemRemote monitoring of ICD and heart failure data | Device | Remote patient management |
| In-Clinic check-upsCalender-based In-Clinic ICD check-up | Other | In-Clinic follow-up, Remote patient management |
Primary outcome
Patient-reported health status
Time frame: 24 months
23-item Kansas City Cardiomyopathy Questionnaire (KCCQ)
Patient-reported device acceptance
Time frame: 24 months
12-item Florida Patient Acceptance Scale (FPAS)
2 secondary outcomes
Patient-reported satisfaction with care
Time frame: 24 months
Cost-effectiveness
Time frame: 24 months
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 8 Jun 2018.
- Derived from this study: PubMed 36245363de Graaf G, Timmermans I, Meine M, Alings M, Pedersen SS, Mabo P, Zitron E, Redekop K, Versteeg H. Economic evaluation of remote monitoring of patients with an implantable cardiac defibrillator (REMOTE-CIED study). J Telemed Telecare. 2024 Aug;30(7):1173-1185. doi: 10.1177/1357633X221129176. Epub 2022 Oct 17.
- Derived from this study: PubMed 34410384Chiu CSL, Timmermans I, Versteeg H, Zitron E, Mabo P, Pedersen SS, Meine M; REMOTE-CIED Trial Investigators. Effect of remote monitoring on clinical outcomes in European heart failure patients with an implantable cardioverter-defibrillator: secondary results of the REMOTE-CIED randomized trial. Europace. 2022 Feb 2;24(2):256-267. doi: 10.1093/europace/euab221.
- Derived from this study: PubMed 31168604Versteeg H, Timmermans I, Widdershoven J, Kimman GJ, Prevot S, Rauwolf T, Scholten MF, Zitron E, Mabo P, Denollet J, Pedersen SS, Meine M. Effect of remote monitoring on patient-reported outcomes in European heart failure patients with an implantable cardioverter-defibrillator: primary results of the REMOTE-CIED randomized trial. Europace. 2019 Sep 1;21(9):1360-1368. doi: 10.1093/europace/euz140.
- Derived from this study: PubMed 30536931Timmermans I, Meine M, Szendey I, Aring J, Romero Roldan J, van Erven L, Kahlert P, Zitron E, Mabo P, Denollet J, Versteeg H. Remote monitoring of implantable cardioverter defibrillators: Patient experiences and preferences for follow-up. Pacing Clin Electrophysiol. 2019 Feb;42(2):120-129. doi: 10.1111/pace.13574. Epub 2019 Jan 2.
- Derived from this study: PubMed 28606488Timmermans I, Versteeg H, Meine M, Pedersen SS, Denollet J. Illness perceptions in patients with heart failure and an implantable cardioverter defibrillator: Dimensional structure, validity, and correlates of the brief illness perception questionnaire in Dutch, French and German patients. J Psychosom Res. 2017 Jun;97:1-8. doi: 10.1016/j.jpsychores.2017.03.014. Epub 2017 Mar 23.
Related trials for Congestive Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
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.
Mathias Meine, MD, PhD principal investigator
UMC Utrecht
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote patient monitoring and In-Clinic check-ups in people with Congestive Heart Failure, run by UMC Utrecht at 1 site in Netherlands.
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 4 inclusion and 4 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 8 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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?
Patient-reported health status (time frame: 24 months). The study lists 2 primary outcomes in all. 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 NCT01691586, which also lists 5 linked publications.
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 8 Jun 2018.