Heart FailureBENEFITNCT00996086
Risk Stratification and Benefits With Cardiac Resynchronization Therapy (CRT)
An observational study of Heart Failure and Ventricular Arrhythmias, run by Abbott Medical Devices at 2 sites in United States.
Trial summary
This is an observational study to learn which patients benefit from CRT therapy and to track the clinical changes that help identify the risk-level of CRT patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Ventricular Arrhythmias
- What is being tested?
- CRT device implant
- Type of treatment
- Medical device
- How many people
- 154 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2010to Sep 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: All patients who undergo implantation of a market-approved St. Jude Medical CRT defibrillator (CRT-D) and a compatible lead system may be included in the study.
Who may be able to join
- Meets current clinical indications for CRT-D therapy
- Patient is 18 years old or older
- Ability to independently comprehend and complete all QOL questionnaires
- Patient has the ability to perform the 6-minute Hall Walk Test (6-MHW) with the only limiting factor being fatigue or shortness-of-breath
- Ability to provide informed consent for a study and be willing and able to comply with the prescribed follow-up
Who cannot join
- Inability to successfully implant an intravascular lead and CRT-D device. (i.e. exclude epicardial leads) within 30 days of initial procedure.
- Myocardial infarction in the last 3 weeks
- Unstable angina in the last 3 weeks
- Status 1 classification for cardiac transplantation
- Currently participating in a clinical trial that includes an active treatment arm
- Life expectancy of less than 12 months.
Show all 9Show fewer
- Recent (within 1 week) administration of Nesiritide™ or inotropes
- Patients in whom revascularization is expected
- Patient is pregnant
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Touro College
New York, New York, 10010
Veterans' Adminstration Pittsburgh Healthcare System
Pittsburgh, Pennsylvania, 15240
About this study
Official title: Risk Stratification and Benefits With Cardiac Resynchronization Therapy
This is an observational study to learn which patients benefit from CRT therapy and to track the clinical changes that help identify the risk-level of CRT patients.
Read the detailed description
The purpose of the study is two-fold. First, to determine if an algorithm can be developed based on pre-implant clinical variables to predict response to CRT-D therapy. Second, the study aims to determine in patients implanted with CRT-D if the combined use of cTnT and BNP can further predict and risk-stratify HF improvement and all-cause mortality. Additionally, novel biochemical markers defining cardiac mortality in high risk patients detected by plasma proteomic analysis in the CRT-D patients will be evaluated.
This study represents a combination of previous CRT studies that evaluated these variables independently. Data from this study will be pooled with data from previous studies to build a more complete picture of CRT therapy.
- Conditions
- Heart Failure, Ventricular Arrhythmias
- Being tested
- CRT device implant
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRT device implantDevice
CRT device-recipients
| Study group | Role | What they receive |
|---|---|---|
| CRT device-recipients | Not described Receives: Device: CRT device implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 6-minute hall walk distance between baseline and subsequent follow-up
Measured: 12 months
Composite endpoint a. 6-minute hall walk distance b. NYHA Classification c. Quality of Life (Minnesota Living with Heart Failure, DASS, SF-36)
Measured: 12 months
The occurrence of either death (all-cause) or first HF hospitalization.
Measured: 12 months
Secondary outcomes (3)
Quality of Life
Measured: 12 months
Change in echocardiographic variables including: a. Ejection Fraction b. Wall motion score c. Increase in TD velocity d. Yu index
Measured: 12 months
Cause-specific mortality
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2009 (estimated)
- Study startFeb 2010
- Primary completionSep 2012
- Study completionSep 2012
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 Abbott Medical DevicesThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Northwestern University, VA Pittsburgh Healthcare System
- Responsible party
- Sponsor
- Investigators
- Alan Kadish, M.D., Principal investigator, Northwestern UniversityAlaa Shalaby, M.D., Principal investigator, VA Pittsburgh Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00996086
- Sponsor's protocol ID
- CRD 480
- Acronym
- BENEFIT
- Status last verified
- Feb 2019
- First submitted
- 14 Oct 2009
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Stratification and Benefits With Cardiac Resynchronization Therapy
- ClinicalTrials.gov ID
- NCT00996086
- Acronym / sponsor ID
- BENEFIT / CRD 480
- Conditions
- Heart Failure, Ventricular Arrhythmias
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Collaborators
- Northwestern University, VA Pittsburgh Healthcare System
- Study start
- Feb 2010
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 16 Oct 2009 (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.
This is an observational study to learn which patients benefit from CRT therapy and to track the clinical changes that help identify the risk-level of CRT patients.
Detailed description
The purpose of the study is two-fold. First, to determine if an algorithm can be developed based on pre-implant clinical variables to predict response to CRT-D therapy. Second, the study aims to determine in patients implanted with CRT-D if the combined use of cTnT and BNP can further predict and risk-stratify HF improvement and all-cause mortality. Additionally, novel biochemical markers defining cardiac mortality in high risk patients detected by plasma proteomic analysis in the CRT-D patients will be evaluated.
This study represents a combination of previous CRT studies that evaluated these variables independently. Data from this study will be pooled with data from previous studies to build a more complete picture of CRT therapy.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CRT device-recipients | – | Device: CRT device implant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who undergo implantation of a market-approved St. Jude Medical CRT defibrillator (CRT-D) and a compatible lead system may be included in the study.
Key inclusion criteria (5 listed)
- Meets current clinical indications for CRT-D therapy
- Patient is 18 years old or older
- Ability to independently comprehend and complete all QOL questionnaires
- Patient has the ability to perform the 6-minute Hall Walk Test (6-MHW) with the only limiting factor being fatigue or shortness-of-breath
- Ability to provide informed consent for a study and be willing and able to comply with the prescribed follow-up
Key exclusion criteria (9 listed)
- Inability to successfully implant an intravascular lead and CRT-D device. (i.e. exclude epicardial leads) within 30 days of initial procedure.
- Myocardial infarction in the last 3 weeks
- Unstable angina in the last 3 weeks
- Status 1 classification for cardiac transplantation
- Currently participating in a clinical trial that includes an active treatment arm
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 |
|---|---|---|
| CRT device implantCRT device-recipients | Device | CRT device-recipients |
Primary outcome
Change in 6-minute hall walk distance between baseline and subsequent follow-up
Time frame: 12 months
Composite endpoint a. 6-minute hall walk distance b. NYHA Classification c. Quality of Life (Minnesota Living with Heart Failure, DASS, SF-36)
Time frame: 12 months
The occurrence of either death (all-cause) or first HF hospitalization.
Time frame: 12 months
3 secondary outcomes
Quality of Life
Time frame: 12 months
Change in echocardiographic variables including: a. Ejection Fraction b. Wall motion score c. Increase in TD velocity d. Yu index
Time frame: 12 months
Cause-specific mortality
Time frame: 12 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 4 Feb 2019.
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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.
Alan Kadish, M.D. principal investigator
Northwestern University
Alaa Shalaby, M.D. principal investigator
VA Pittsburgh Healthcare System
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 Heart Failure and Ventricular Arrhythmias, run by Abbott Medical Devices at 2 sites in United States.
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 9 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 4 Feb 2019. 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. 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?
Change in 6-minute hall walk distance between baseline and subsequent follow-up (time frame: 12 months). The study lists 3 primary outcomes in all. 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 4 Feb 2019.