Chronic Heart FailureNCT03474315
Interactive Patient's Assistant - LUCY
An observational study of Chronic Heart Failure, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
Patients with chronic heart failure (CHF) and reduced left ventricle ejection fraction benefit from cardiac resynchronization therapy (CRT) and implantable cardioverter defibrillator (ICD). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Chronic Heart Failure
- What is being tested?
- Multivariate assessment
- How many people
- 600 participants
- Where
- 1 sitePoland
- Study dates
- Apr 2018to Feb 2019
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will be consisted of one patient group: 600 CHF patients with implanted ICD or CRT admitted to regulatory ambulatory visit.
Who may be able to join
- 18-90 years old
- Chronic heart failure (NYHA class I to III)
- Implanted ICD or CRT (at least 30 days before inclusion)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Medical Informatics and Telemedicine
Warsaw, Masovian Voivodeship, 02-097
Andrzej Cacko, MD PhD, +48 509892324, andrzej.cacko@gmail.com
About this study
Official title: Interactive Patient's Assistant to Optimize Long-term Care in Patients With Chronic Health Failure and Determine Which Parameters of CIED Indicate the Requirement for Ambulatory Follow-up
Patients with chronic heart failure (CHF) and reduced left ventricle ejection fraction benefit from cardiac resynchronization therapy (CRT) and implantable cardioverter defibrillator (ICD). Currently used devices, besides delivering low and high-energy therapies, record patient's activity and many hemodynamic parameters. However, increasing numbers of patient with CRT and ICD devices produce overload of cardiology centers where patients are admitted to ambulatory visits. Contrarily, there are technological possibilities for remote monitoring proven to be effective in recognizing damage of the implanted device and risk of exacerbation of chronic heart failure. Patients' registries show that majority of ambulatory visits are unproductive and do not result in significant modification of device's parameters. Promising experiences with application of data mining and machine learning techniques allow us to assume probable benefits from using modern methods of data analysis in determination of requirement for ambulatory follow-up on basis of data gathered through telemonitoring and clinical assessment of a patient.
Aim of the study is to find multivariate model predicting the requirement for ambulatory follow-up of IECD.
- Conditions
- Chronic Heart Failure
- Being tested
- Multivariate assessment
- Keywords
- Cardiac implantable electronic device, Cardiac resynchronization therapy, Implantable cardioverter-defibrillator, Machine learning, Mobile application, Patient's assistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multivariate assessmentDiagnostic test
Patient's status assessment according to clinical evaluation and data acquired from the implanted device.
| Study group | Role | What they receive |
|---|---|---|
| CHF and CIED patients | 600 CHF patients with ICD or CRT admitted to regulatory ambulatory visit. Receives: Diagnostic Test: Multivariate assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ambulatory visit qualified as meaningful due to change in pharmacotherapy or ICD parameters related to tachycardia detection or treatment.
Primary outcome is composed of:
- any change in pharmacotherapy (modification of agents or doses) related to patient's clinical status assessed during the visit,
- any change in tachyarrythmia counter or discriminator status,
- any change in tachyarrythmia threshold,
- ventricular undersensing or oversensing.
Measured: 1 day
Secondary outcomes (1)
Ambulatory visit qualified as meaningful due to alarming condition related to ICD.
Secondary outcome is composed of:
- sustained or treated ventricular tachyarrythmia,
- any not previously diagnosed supraventricular tachyarrythmia,
- elective replacement indicator,
- atrial undersensing or oversensing,
- atrial or ventricular ineffective pacing.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2018
- Study startApr 2018 (estimated)
- Primary completionFeb 2019 (estimated)
- Study completionFeb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcin Grabowski, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03474315
- Sponsor's protocol ID
- LUCY
- Status last verified
- Mar 2018
- First submitted
- 13 Dec 2017
- Last updated
- 22 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interactive Patient's Assistant to Optimize Long-term Care in Patients With Chronic Health Failure and Determine Which Parameters of CIED Indicate the Requirement for Ambulatory Follow-up
- ClinicalTrials.gov ID
- NCT03474315
- Acronym / sponsor ID
- LUCY
- Conditions
- Chronic Heart Failure
- Keywords
- Cardiac implantable electronic device, Cardiac resynchronization therapy, Implantable cardioverter-defibrillator, Machine learning, Mobile application, Patient's assistance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- Apr 2018 (estimated)
- Primary completion
- Feb 2019 (estimated)
- Study completion
- Feb 2019 (estimated)
- First posted
- 22 Mar 2018 (actual)
- 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.
Patients with chronic heart failure (CHF) and reduced left ventricle ejection fraction benefit from cardiac resynchronization therapy (CRT) and implantable cardioverter defibrillator (ICD). Currently used devices, besides delivering low and high-energy therapies, record patient's activity and many hemodynamic parameters. However, increasing numbers of patient with CRT and ICD devices produce overload of cardiology centers where patients are admitted to ambulatory visits. Contrarily, there are technological possibilities for remote monitoring proven to be effective in recognizing damage of the implanted device and risk of exacerbation of chronic heart failure. Patients' registries show that majority of ambulatory visits are unproductive and do not result in significant modification of device's parameters. Promising experiences with application of data mining and machine learning techniques allow us to assume probable benefits from using modern methods of data analysis in determination of requirement for ambulatory follow-up on basis of data gathered through telemonitoring and clinical assessment of a patient.
Aim of the study is to find multivariate model predicting the requirement for ambulatory follow-up of IECD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CHF and CIED patients | – | Diagnostic Test: Multivariate assessment600 CHF patients with ICD or CRT admitted to regulatory ambulatory visit. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will be consisted of one patient group: 600 CHF patients with implanted ICD or CRT admitted to regulatory ambulatory visit.
Key inclusion criteria (3 listed)
- 18-90 years old
- Chronic heart failure (NYHA class I to III)
- Implanted ICD or CRT (at least 30 days before inclusion)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Multivariate assessmentPatient's status assessment according to clinical evaluation and data acquired from the implanted device. | Diagnostic test | CHF and CIED patients |
Primary outcome
Ambulatory visit qualified as meaningful due to change in pharmacotherapy or ICD parameters related to tachycardia detection or treatment.
Time frame: 1 day
Primary outcome is composed of: * any change in pharmacotherapy (modification of agents or doses) related to patient's clinical status assessed during the visit, * any change in tachyarrythmia counter or discriminator status, * any change in tachyarrythmia threshold, * ventricular undersensing or oversensing.
1 secondary outcome
Ambulatory visit qualified as meaningful due to alarming condition related to ICD.
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2018.
- Individual participant dataSharing planned: No
Related trials for Chronic Heart Failure
Recruiting
Laser Acupuncture for Fatigue in Hemodialysis Patients
ESRD (End Stage Renal Disease), Dialysis
RecruitingPhase 3
Qishen Yiqi Dripping Pills in Treatment of Chronic Heart FailUre
Heart Failure
RecruitingObservational study
Sensor-based Congestion ALert for Events in Peritoneal Dialysis (SCALE-PD)
Kidney Disease, Peritoneal Dialysis (PD)
Active, not recruitingObservational study
Expanded Studies on the SCAPIS Stockholm Reexamination Cohort
Coronary Artery Disease, Arterial Stiffness, Blood Pressure
Not yet recruiting
Exercise, Mediterranean Diet and Inflammation in Heart Failure
Heart Failure, Heart Failure Preserved Ejection Fraction
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Heart Failure, run by Medical University of Warsaw at 1 site in Poland.
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 3 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 22 Mar 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 Poland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrzej Cacko, MD PhD (+48 509892324, andrzej.cacko@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ambulatory visit qualified as meaningful due to change in pharmacotherapy or ICD parameters related to tachycardia detection or treatment. (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Mar 2018.