Heart FailureCORRELATE-HFNCT00758121
Correlation Of Respiratory Rate Level And Trend Evaluation in Heart Failure Patients
An observational study of Heart Failure, run by Boston Scientific Corporation at 2 sites in 2 countries.
Trial summary
The objective of the study is to determine if there is any relationship between respiratory rate and Heart Failure events. 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?
- Cardiac Resynchronization Therapy Defibrillator
- Type of treatment
- Medical device
- How many people
- 56 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Nov 2008to Oct 2009
- 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: Heart failure patients with an implanted CRT-D.
Who may be able to join
- Implanted COGNIS device or future commercially available Boston Scientific CRT-D, that contains the Sensor Trend for Respiratory Rate, with a right ventricular lead and left ventricular lead actively implanted
- Respiratory Sensor programmed "On"
- Classified as having NYHA Class III heart failure documented, in the past 12 months
- Age 18 or above, or of legal age to give informed consent specific to state and national law
- Willing and capable of providing informed consent, participating in all testing associated with this clinical investigation at an approved clinical investigational center and at the intervals defined by this protocol
Who cannot join
- Inability or refusal to sign the patient Informed Consent
- Inability or refusal to comply with the follow-up schedule
- Patients that have received routinely scheduled intravenous inotropic therapy as part of their drug regimen within the past 90 days
- Patients prescribed to positive airway pressure therapy
- A life expectancy of less than 180 days, per physician discretion
- Enrolled in any concurrent study without prior written approval from Boston Scientific CRM
- Women who are pregnant or plan to become pregnant in the next twelve months
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
San Diego Cardiac Center
San Diego, California, 91213
About this study
Official title: CORRELATE-HF: Correlation Of Respiratory Rate Level And Trend Evaluation in Heart Failure Patients
The objective of the study is to determine if there is any relationship between respiratory rate and Heart Failure events.
Read the detailed description
The purpose of the CORRELATE-HF study is to collect RRT data in heart failure patients to gain a better understanding of how respiratory rate changes in relation to all cause clinical events as well as other diagnostic features, including but not limited to, activity level, heart rate, and lead impedance.
- Conditions
- Heart Failure
- Being tested
- Cardiac Resynchronization Therapy Defibrillator
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac Resynchronization Therapy DefibrillatorDevice
CRT-D observational study
| Study group | Role | What they receive |
|---|---|---|
| Observation | Heart failure patients with an implanted CRT-D Receives: Device: Cardiac Resynchronization Therapy Defibrillator |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2008 (estimated)
- Study startNov 2008
- Primary completionOct 2009
- Study completionOct 2009
Why it stopped: Inappropriate therapy associated with certain right ventricular (RV) lead complications may occur more frequently if the Respiratory Sensor is programmed On
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.
- More trials run by Boston Scientific CorporationThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Brian Jaski, MD, Principal investigator, San Diego Cardiac CenterPedro Brugada, MD, Principal investigator, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00758121
- Sponsor's protocol ID
- CR-CA-091008-H
- Acronym
- CORRELATE-HF
- Status last verified
- Nov 2009
- First submitted
- 19 Sep 2008
- Last updated
- 6 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CORRELATE-HF: Correlation Of Respiratory Rate Level And Trend Evaluation in Heart Failure Patients
- ClinicalTrials.gov ID
- NCT00758121
- Acronym / sponsor ID
- CORRELATE-HF / CR-CA-091008-H
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Inappropriate therapy associated with certain right ventricular (RV) lead complications may occur more frequently if the Respiratory Sensor is programmed On
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 23 Sep 2008 (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 objective of the study is to determine if there is any relationship between respiratory rate and Heart Failure events.
Detailed description
The purpose of the CORRELATE-HF study is to collect RRT data in heart failure patients to gain a better understanding of how respiratory rate changes in relation to all cause clinical events as well as other diagnostic features, including but not limited to, activity level, heart rate, and lead impedance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observation | – | Device: Cardiac Resynchronization Therapy DefibrillatorHeart failure patients with an implanted CRT-D |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Heart failure patients with an implanted CRT-D.
Key inclusion criteria (5 listed)
- Implanted COGNIS device or future commercially available Boston Scientific CRT-D, that contains the Sensor Trend for Respiratory Rate, with a right ventricular lead and left ventricular lead actively implanted
- Respiratory Sensor programmed "On"
- Classified as having NYHA Class III heart failure documented, in the past 12 months
- Age 18 or above, or of legal age to give informed consent specific to state and national law
- Willing and capable of providing informed consent, participating in all testing associated with this clinical investigation at an approved clinical investigational center and at the intervals defined by this protocol
Key exclusion criteria (7 listed)
- Inability or refusal to sign the patient Informed Consent
- Inability or refusal to comply with the follow-up schedule
- Patients that have received routinely scheduled intravenous inotropic therapy as part of their drug regimen within the past 90 days
- Patients prescribed to positive airway pressure therapy
- A life expectancy of less than 180 days, per physician discretion
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 |
|---|---|---|
| Cardiac Resynchronization Therapy DefibrillatorCRT-D observational study | Device | Observation |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Inappropriate therapy associated with certain right ventricular (RV) lead complications may occur more frequently if the Respiratory Sensor is programmed On). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2009.
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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.
Brian Jaski, MD principal investigator
San Diego Cardiac Center
Pedro Brugada, MD principal investigator
Universitair Ziekenhuis Brussel
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Boston Scientific Corporation at 2 sites in 2 countries.
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 5 inclusion and 7 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: stopped early, as of the sponsor's last update on 6 Nov 2009. 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 United States, Belgium. 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 was stopped early (reason given: Inappropriate therapy associated with certain right ventricular (RV) lead complications may occur more frequently if the Respiratory Sensor is programmed On). Results are not available in the source record.
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.
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 6 Nov 2009.