Congestive Heart FailureMULTITUDE-HFNCT01501331
Multiparametric Heart Failure Evaluation in Internal Cardioverter Defibrillators (ICD) Patients
An observational study of Congestive Heart Failure, run by University of Rome Tor Vergata at 2 sites in Italy.
Trial summary
The Boston Scientific Energen family is capable of measuring the respiratory rate trend (RRT) on a daily basis and transmission of data via the Remote Monitoring technology. This may result in early detection of imminent decompensation at a presymptomatic stage. 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?
- CRTD or ICD (Energen)
- Type of treatment
- Medical device
- How many people
- 180 participants
- Where
- 2 sitesItaly
- Study dates
- Dec 2011to Nov 2014
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients implanted with an Energen device or successor using the RRT diagnostic tool
Who may be able to join
- Patient eligible for 1-, 2- or 3-chamber ICD implantation according to current guidelines or patient already implanted within the past 45 days with a Energen device or successor
- Able to provide written informed consent
Who cannot join
- Life expectancy <12 months
- Anticipated non-compliance with the follow-up scheme
- Moderate to severe Chronic Obstructive Pulmonary Disease
- Primary pulmonary hypertension
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Multiparametric Evaluation of Heart Failure in Device-implanted Patients.
The Boston Scientific Energen family is capable of measuring the respiratory rate trend (RRT) on a daily basis and transmission of data via the Remote Monitoring technology. This may result in early detection of imminent decompensation at a presymptomatic stage. The study will assess the respiratory trends correlation with clinically relevant heart failure events.
- Conditions
- Congestive Heart Failure
- Being tested
- CRTD or ICD (Energen)
- Keywords
- Congestive Heart Failure, Cardiac Resynchronization Therapy, Internal Cardioverter Defibrillators
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRTD or ICD (Energen)Device
RRT measurement by cardiac resynchronization therapy devices and implantable cardioverter defibrillators
| Study group | Role | What they receive |
|---|---|---|
| RRT diagnostic tool | Patients implanted with an Energen device or successor. Receives: Device: CRTD or ICD (Energen) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prediction by RRT of cardiovascular death or rehospitalization for worsening of heart failure symptoms.
Respiratory rate changes (maximum, median and minimum values) before a primary event (3-, 2-, 1-week before and on the day of the event) will be compared to those at baseline (6 weeks prior the event).
Pts with less than 30-day of RR data or events without sufficient baseline will be excluded from the analysis
Measured: 24 months
Secondary outcomes (3)
Proportion of in-hospital consultations with relevant findings (i.e. necessitating changes in medical therapy, device programming or re-hospitalisations/ interventions)
Respiratory rate changes (maximum, median and minimum values) before the event (3-, 2-, 1-week before and on the day of the event) will be compared to those at baseline (6 weeks prior the event).
Pts with less than 30-day of RR data or events without sufficient baseline will be excluded from the analysis
Measured: 24 months
Correlation of RRT with appropriate ICD therapy (ATP or Shock)
Respiratory rate changes (maximum, median and minimum values) before the event (3-, 2-, 1-week before and on the day of the event) will be compared to those at baseline (6 weeks prior the event).
Pts with less than 30-day of RR data or events without sufficient baseline will be excluded from the analysis
Measured: 24 months
Correlation of RRT with atrial and ventricular arrhythmias
Respiratory rate changes (maximum, median and minimum values) before the event (3-, 2-, 1-week before and on the day of the event) will be compared to those at baseline (6 weeks prior the event).
Pts with less than 30-day of RR data or events without sufficient baseline will be excluded from the analysis
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 posted29 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive 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
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rome Tor Vergata
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giovanni B Forleo, University of Rome Tor Vergata
- Investigators
- Giovanni B Forleo, MD, PhD, Principal investigator, University of Rome Tor VergataLuca Santini, MD, PhD, Principal investigator, University of Rome Tor Vergata
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01501331
- Sponsor's protocol ID
- PTVCARDIO2011_01
- Acronym
- MULTITUDE-HF
- Status last verified
- Nov 2014
- First submitted
- 6 Dec 2011
- Last updated
- 18 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiparametric Evaluation of Heart Failure in Device-implanted Patients.
- ClinicalTrials.gov ID
- NCT01501331
- Acronym / sponsor ID
- MULTITUDE-HF / PTVCARDIO2011_01
- Conditions
- Congestive Heart Failure
- Keywords
- Congestive Heart Failure, Cardiac Resynchronization Therapy, Internal Cardioverter Defibrillators
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University of Rome Tor VergataUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 29 Dec 2011 (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.
The Boston Scientific Energen family is capable of measuring the respiratory rate trend (RRT) on a daily basis and transmission of data via the Remote Monitoring technology. This may result in early detection of imminent decompensation at a presymptomatic stage. The study will assess the respiratory trends correlation with clinically relevant heart failure events.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RRT diagnostic tool | – | Device: CRTD or ICD (Energen)Patients implanted with an Energen device or successor. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients implanted with an Energen device or successor using the RRT diagnostic tool
Key inclusion criteria (2 listed)
- Patient eligible for 1-, 2- or 3-chamber ICD implantation according to current guidelines or patient already implanted within the past 45 days with a Energen device or successor
- Able to provide written informed consent
Key exclusion criteria (4 listed)
- Life expectancy <12 months
- Anticipated non-compliance with the follow-up scheme
- Moderate to severe Chronic Obstructive Pulmonary Disease
- Primary pulmonary hypertension
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 |
|---|---|---|
| CRTD or ICD (Energen)RRT measurement by cardiac resynchronization therapy devices and implantable cardioverter defibrillators | Device | RRT diagnostic tool |
Primary outcome
Prediction by RRT of cardiovascular death or rehospitalization for worsening of heart failure symptoms.
Time frame: 24 months
Respiratory rate changes (maximum, median and minimum values) before a primary event (3-, 2-, 1-week before and on the day of the event) will be compared to those at baseline (6 weeks prior the event). Pts with less than 30-day of RR data or events without sufficient baseline will be excluded from the analysis
3 secondary outcomes
Proportion of in-hospital consultations with relevant findings (i.e. necessitating changes in medical therapy, device programming or re-hospitalisations/ interventions)
Time frame: 24 months
Correlation of RRT with appropriate ICD therapy (ATP or Shock)
Time frame: 24 months
Correlation of RRT with atrial and ventricular arrhythmias
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 18 Nov 2014.
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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.
Giovanni B Forleo, MD, PhD principal investigator
University of Rome Tor Vergata
Luca Santini, MD, PhD principal investigator
University of Rome Tor Vergata
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congestive Heart Failure, run by University of Rome Tor Vergata at 2 sites in Italy.
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 2 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 18 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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?
Prediction by RRT of cardiovascular death or rehospitalization for worsening of heart failure symptoms. (time frame: 24 months). 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 18 Nov 2014.