Heart FailurepharaoNCT01366703
Optimized Heart Failure Therapy Through Continuous Monitoring
An observational study of Heart Failure, run by Kennemer Gasthuis at 5 sites in Netherlands.
Trial summary
Patients with heart failure have a high incidence of atrial fibrillation (AF)and re-admission for heart failure. New methods have been developed to continuously monitor arrhythmia's and heart failure parameters. One such method is implantation of an implantable loop recorder. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- implantable loop recorder Medtronic reveal XT Full view
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 5 sitesNetherlands
- Study dates
- May 2011to Dec 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 50 patients with stable heart failure
Who may be able to join
- EF > 35%
- NYHA 2-3
- No AF documented
- Not on OAC
Who cannot join
- use of OAC
- documented AF > 30 sec
- planned or actual PM/ICD
- life-expectancy < 1 year
- no informed consent
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Netherlands5 sites, 5 recruiting
- Recruiting
Rijnstate ziekenhuis
Arnhem
hans bosker, MD PhD, hbosker@alysis.nl
- Recruiting
Deventer Ziekenhuis
Deventer
Ype Tuininga, MD PhD, y.s.tuininga@dz.nl
- Not yet recruiting
Martini Ziekenhuis
Groningen
Robert Tieleman, MD PhD, r.tieleman@mzh.nl
- Recruiting
Kennemer gasthuis
Haarlem, 2000 AK
raymond tukkie, MD PhD, +31 23 5453545, tukkie@kg.nl
Bob van Vlies, MD PhD, +31 23 5453545, vlies@kg.nl
- Recruiting
Rijnland Ziekenhuis
Leiderdorp
Charles Kirchhof, MD PhD, ch.kirchhof@orange.nl
About this study
Official title: Optimized Heart Failure Therapy Through Continuous Monitoring. The PHARAO Multi-centre Study
Patients with heart failure have a high incidence of atrial fibrillation (AF)and re-admission for heart failure. New methods have been developed to continuously monitor arrhythmia's and heart failure parameters. One such method is implantation of an implantable loop recorder. Also home-monitoring is available for continuous monitoring and information sending to the treating physicians, with improving detection of atrial fibrillation (AF) and/or other sever arrhythmia's we hope to improve patient care.
Objective of the study:
Read more
To investigate the clinical efficacy in detecting clinically relevant arrhythmia's (especially AF) of the Reveal XT in patients with mild to moderate heart failure and elevated risk factor for stroke and transient ischemic attack (TIA)(CHADS-score >2), currently not treated with oral anticoagulation (OAC).
Study design:
In 50 stable sinus rhythm (no known AF)patients with New York health Association (NYHA class) 2-3, a CHADS2-score>2 and no indication for a implantable cardioverter-defibrillator (ICD) or pacemaker (PM) or OAC. Patients are put on home-monitoring (CareLink) and regular outward clinic visits. The number of relevant arrhythmia's detected will count for the primary endpoint. Also the number of medication changes and institution of OAC.
Study population:
50 stable patients, recruited from the outward clinic. NYHA class 2-3. Reveal XT implantation. CHADS2-score 2 or more. No indication for ICD/PM or OAC. No AF known.
Primary study parameters/outcome of the study:
Primary endpoints
- AF burden and AF episodes detected
- Detected other relevant arrhythmia's like SVT's (not AF) or ventricular tachycardias (VT's) or bradycardias
- % patients on OAC after 1 year follow-up
- Number of clinically relevant patient activated events
- Number of treatment policy changes based on the Reveal XT
Secondary study parameters/outcome of the study
- specificity of AF detection algorithm by the Reveal
- Predictive value of the cardiac Compass data to predict worsening heart failure episodes.
Read the detailed description
no additional description needed
- Conditions
- Heart Failure
- Being tested
- implantable loop recorder Medtronic reveal XT Full view
- Keywords
- heart failure, implantable loop recorder
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
implantable loop recorder Medtronic reveal XT Full viewDevice
Also called Medtronic reveal XT Full view
Medtronic Reveal implantable loop recorder with home-monitoring using carelink will be implanted in every patient and used to continuously monitor the patients during follow-up to detect symptomatic and asymptomatic arrythmias during follow-up
| Study group | Role | What they receive |
|---|---|---|
| heart failure patients | stable heart failure patients, NYHA 1-2, EF > 35%, no AF, No OAC, CHADS score >2 Receives: Device: implantable loop recorder Medtronic reveal XT Full view |
What is being measured
The primary outcome is the main question the study is designed to answer.
registered arrhythmias with implantable loop recorder during follow-up period
Primary study parameters/outcome of the study:
- AF burden en AF episodes detected
- Detected other relevant arrhythmia's like supraventricular tachycardia's (SVT's, not AF) or ventricular tachycardia's (VT's) or bradycardias
- % patiënts on OAC after 1 year follow-up
- Number of clinically relevant patient activated events
- Number of treatment policy changes based on the Reveal XT
Measured: 1 year follow-up after last included patient
Secondary outcomes (1)
prediction of worsening heart failure through cardiac compass
Predective value of the cardiac Compass data to predict worsening heart failure episodes.
Measured: during follow-up (1 year after last included patient)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2011 (estimated)
- Study startMay 2011
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kennemer Gasthuis
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Principal investigator, Dr. R. Tukkie MD PhD FESC, Kennemer Gasthuis
- Investigators
- raymond tukkie, MD PhD, Principal investigator, Kennemer Gasthuis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01366703
- Sponsor's protocol ID
- pharao multicentre study
- Acronym
- pharao
- Status last verified
- May 2012
- First submitted
- 2 Jun 2011
- Last updated
- 15 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimized Heart Failure Therapy Through Continuous Monitoring. The PHARAO Multi-centre Study
- ClinicalTrials.gov ID
- NCT01366703
- Acronym / sponsor ID
- pharao / pharao multicentre study
- Conditions
- Heart Failure
- Keywords
- heart failure, implantable loop recorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Kennemer GasthuisUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- May 2011
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 6 Jun 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.
Patients with heart failure have a high incidence of atrial fibrillation (AF)and re-admission for heart failure. New methods have been developed to continuously monitor arrhythmia's and heart failure parameters. One such method is implantation of an implantable loop recorder. Also home-monitoring is available for continuous monitoring and information sending to the treating physicians, with improving detection of atrial fibrillation (AF) and/or other sever arrhythmia's we hope to improve patient care.
Objective of the study:
To investigate the clinical efficacy in detecting clinically relevant arrhythmia's (especially AF) of the Reveal XT in patients with mild to moderate heart failure and elevated risk factor for stroke and transient ischemic attack (TIA)(CHADS-score >2), currently not treated with oral anticoagulation (OAC).
Study design:
In 50 stable sinus rhythm (no known AF)patients with New York health Association (NYHA class) 2-3, a CHADS2-score>2 and no indication for a implantable cardioverter-defibrillator (ICD) or pacemaker (PM) or OAC. Patients are put on home-monitoring (CareLink) and regular outward clinic visits. The number of relevant arrhythmia's detected will count for the primary endpoint. Also the number of medication changes and institution of OAC.
Study population:
50 stable patients, recruited from the outward clinic. NYHA class 2-3. Reveal XT implantation. CHADS2-score 2 or more. No indication for ICD/PM or OAC. No AF known.
Primary study parameters/outcome of the study:
Primary endpoints
- AF burden and AF episodes detected
- Detected other relevant arrhythmia's like SVT's (not AF) or ventricular tachycardias (VT's) or bradycardias
- % patients on OAC after 1 year follow-up
- Number of clinically relevant patient activated events
- Number of treatment policy changes based on the Reveal XT
Secondary study parameters/outcome of the study
- specificity of AF detection algorithm by the Reveal
- Predictive value of the cardiac Compass data to predict worsening heart failure episodes.
Detailed description
no additional description needed
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| heart failure patients | – | Device: implantable loop recorder Medtronic reveal XT Full viewstable heart failure patients, NYHA 1-2, EF > 35%, no AF, No OAC, CHADS score >2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 50 patients with stable heart failure
Key inclusion criteria (4 listed)
- EF > 35%
- NYHA 2-3
- No AF documented
- Not on OAC
Key exclusion criteria (5 listed)
- use of OAC
- documented AF > 30 sec
- planned or actual PM/ICD
- life-expectancy < 1 year
- no informed consent
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 |
|---|---|---|
| implantable loop recorder Medtronic reveal XT Full viewAlso: Medtronic reveal XT Full viewMedtronic Reveal implantable loop recorder with home-monitoring using carelink will be implanted in every patient and used to continuously monitor the patients during follow-up to detect symptomatic and asymptomatic arrythmias during follow-up | Device | heart failure patients |
Primary outcome
registered arrhythmias with implantable loop recorder during follow-up period
Time frame: 1 year follow-up after last included patient
Primary study parameters/outcome of the study: * AF burden en AF episodes detected * Detected other relevant arrhythmia's like supraventricular tachycardia's (SVT's, not AF) or ventricular tachycardia's (VT's) or bradycardias * % patiënts on OAC after 1 year follow-up * Number of clinically relevant patient activated events * Number of treatment policy changes based on the Reveal XT
1 secondary outcome
prediction of worsening heart failure through cardiac compass
Time frame: during follow-up (1 year after last included patient)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2012.
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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.
raymond tukkie, MD PhD principal investigator
Kennemer Gasthuis
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Kennemer Gasthuis at 5 sites 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 5 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 15 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact raymond tukkie, MD PhD (+31 23 5453545, tukkie@kg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
registered arrhythmias with implantable loop recorder during follow-up period (time frame: 1 year follow-up after last included patient). 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 15 May 2012.