Heart FailureRISKNCT00453622
RISK Stratification Using a Combination of Cardiac Troponin T and Brain Natriuretic Peptide in Patients Receiving CRT-D
An observational study of Heart Failure, run by Abbott Medical Devices at 1 site in United States.
Trial summary
The purpose of the study is to identify if the combined use of cardiac troponin enzyme (cTnT) and brain natriuretic peptide (BNP) can predict Heart Failure (HF)improvement and all-cause mortality in patients implanted with cardiac pacemaker-defibrillation devices (CRT-D). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Cardiac Resynchronization Therapy-Defibrillator
- Type of treatment
- Medical device
- How many people
- 222 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2005to Aug 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: heart failure patients indicated for the CRT-D therapy
Who may be able to join
- Referred for implantation of CRT-D according to currently accepted guidelines.
- 18 years or older
- Ability to independently comprehend and complete a QOL questionnaire
- Ability to provide informed consent for a study and be willing and able to comply with the prescribed follow-up
- Has stable conventional medications at least one month prior to enrollment
Who cannot join
- Inability to successfully implant an intravascular lead CRT-D device. (i.e. exclude epicardial leads)
- Myocardial infarction or unstable angina in the last 3 weeks
- Chronic atrial fibrillation (continuous AF lasting > 1 Month) within 1 year prior to enrollment or having undergone cardioversion for AF in the past month
- Status 1 classification for cardiac transplantation
- Currently participating in a clinical trial that includes an active treatment arm
- Life expectancy of less than 6 months.
- Recent (within 24 hours) administration of Nesiritide™
Trial locations and contacts
1 site in 1 country.
United States1 site
Veterans' Adminstration Pittsburgh Healthcare System
Pittsburgh, Pennsylvania, 15240
About this study
The purpose of the study is to identify if the combined use of cardiac troponin enzyme (cTnT) and brain natriuretic peptide (BNP) can predict Heart Failure (HF)improvement and all-cause mortality in patients implanted with cardiac pacemaker-defibrillation devices (CRT-D). Novel biochemical markers identifying patients with high risk cardiac mortality detected by plasma protein analysis will also be evaluated.
Hypothesis #1: The combined use of cTnT and BNP at just before implant will predict and risk stratify all cause mortality or HF hospitalization up to 12 months.
Read more
Hypothesis #2: The change in levels of said biomarkers at different points of follow-up can predict response to CRT through 12 months.
Hypothesis #3: The levels of a panel of novel inflammatory mediators, namely chemokines, will be correlated with improvement in 6-minute walk testing, quality of life, and left ventricular ejection fraction in CRT patients.
Read the detailed description
Primary Endpoint
The primary endpoint is the occurrence of either death or first HF hospitalization. HF hospitalizations must satisfy both of the following criteria:
- Admission to hospital for >24 hours with at least one of the following HF worsening symptoms:
- Increased CHF class
- Orthopnea
- Paroxysmal nocturnal dyspnea
- Edema
- Dyspnea on exertion, or
- Gastrointestinal (GI) symptoms attributable to HF
- Placement on the Status I heart transplant list AND
- One or more of the following intensive treatment(s) for HF within 24 hours of admission:
- Intravenous (IV) diuresis
- IV inotropic medications prescribed during the hospitalization, or
- Increasing frequency of dialysis for patients with chronic renal failure
2.3 Secondary Endpoints
Secondary endpoints include:
- Cause of death
- Change in NYHA functional class
- Number of HF related hospitalizations
- Performance on a standard 6-minute hall walk test
- Quality of Life as measured by the Minnesota Living with Heart Failure (MLWHFQ) questionnaire
- Patient global clinical assessment
- Left ventricular ejection fraction (LVEF) measured by echocardiography
- LV volume measured by echocardiography
- LV lead placement position
- QRS duration at baseline and with CRT
- Number of AT/AF, VT/VF episodes
- Frequency of appropriate/inappropriate ICD therapy
- % Atrial and Ventricular Pacing
- Antiarrhythmic drug utilization
- Study related complications
2.3.1 Response to CRT
- A positive response to CRT is defined by the following: Improvement in NYHA functional class by at least one grade
- Improvement in echocardiographic LVEF \& left ventricular end diastolic index (LVEDI)
- Improvement in patient global clinical assessment
- Improvement in 6-minute hall walk by 10%
- Conditions
- Heart Failure
- Being tested
- Cardiac Resynchronization Therapy-Defibrillator
- Keywords
- Heart Failure, Cardiac Resynchronization Therapy, Risk stratification, Prediction, Proteomics, Chemokine, cardiac enzymes, Brain Natriuretic Peptide
- 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
Also called CRT-D device
Implantation of a CRT-D device
What is being measured
The primary outcome is the main question the study is designed to answer.
All Cause Death
Measured: 1 year follow up
First Heart Failure Hospitalization
Measured: 1 year follow up
Secondary outcomes (1)
• Cause of death and ejection fraction
Measured: 1 year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2007 (estimated)
- Study startNov 2005
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 222 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- VA Pittsburgh Healthcare System
- Responsible party
- Sponsor
- Investigators
- Aala Shalaby, MD, FACC, Principal investigator, Veteran's Administration, Pittsburgh Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00453622
- Sponsor's protocol ID
- CRD303
- Acronym
- RISK
- Status last verified
- Feb 2019
- First submitted
- 27 Mar 2007
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Shalaby AA, Abraham WT, Fonarow GC, Bersohn MM, Gorcsan J 3rd, Lee LY, Halilovic J, Saba S, Maisel A, Singh JP, Sonel A, Kadish A. Association of BNP and Troponin Levels with Outcome among Cardiac Resynchronization Therapy Recipients. Pacing Clin Electrophysiol. 2015 May;38(5):581-90. doi: 10.1111/pace.12610. Epub 2015 Mar 30.
PubMed 25677851
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 Using a Combination of Cardiac Troponin T and Brain Natriuretic Peptide in Patients Receiving CRT-D
- ClinicalTrials.gov ID
- NCT00453622
- Acronym / sponsor ID
- RISK / CRD303
- Conditions
- Heart Failure
- Keywords
- Heart Failure, Cardiac Resynchronization Therapy, Risk stratification, Prediction, Proteomics, Chemokine, cardiac enzymes, Brain Natriuretic Peptide
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 222 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Collaborators
- VA Pittsburgh Healthcare System
- Study start
- Nov 2005
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 29 Mar 2007 (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 purpose of the study is to identify if the combined use of cardiac troponin enzyme (cTnT) and brain natriuretic peptide (BNP) can predict Heart Failure (HF)improvement and all-cause mortality in patients implanted with cardiac pacemaker-defibrillation devices (CRT-D). Novel biochemical markers identifying patients with high risk cardiac mortality detected by plasma protein analysis will also be evaluated.
Hypothesis #1: The combined use of cTnT and BNP at just before implant will predict and risk stratify all cause mortality or HF hospitalization up to 12 months.
Hypothesis #2: The change in levels of said biomarkers at different points of follow-up can predict response to CRT through 12 months.
Hypothesis #3: The levels of a panel of novel inflammatory mediators, namely chemokines, will be correlated with improvement in 6-minute walk testing, quality of life, and left ventricular ejection fraction in CRT patients.
Detailed description
Primary Endpoint
The primary endpoint is the occurrence of either death or first HF hospitalization. HF hospitalizations must satisfy both of the following criteria:
- Admission to hospital for >24 hours with at least one of the following HF worsening symptoms:
- Increased CHF class
- Orthopnea
- Paroxysmal nocturnal dyspnea
- Edema
- Dyspnea on exertion, or
- Gastrointestinal (GI) symptoms attributable to HF
- Placement on the Status I heart transplant list AND
- One or more of the following intensive treatment(s) for HF within 24 hours of admission:
- Intravenous (IV) diuresis
- IV inotropic medications prescribed during the hospitalization, or
- Increasing frequency of dialysis for patients with chronic renal failure
2.3 Secondary Endpoints
Secondary endpoints include:
- Cause of death
- Change in NYHA functional class
- Number of HF related hospitalizations
- Performance on a standard 6-minute hall walk test
- Quality of Life as measured by the Minnesota Living with Heart Failure (MLWHFQ) questionnaire
- Patient global clinical assessment
- Left ventricular ejection fraction (LVEF) measured by echocardiography
- LV volume measured by echocardiography
- LV lead placement position
- QRS duration at baseline and with CRT
- Number of AT/AF, VT/VF episodes
- Frequency of appropriate/inappropriate ICD therapy
- % Atrial and Ventricular Pacing
- Antiarrhythmic drug utilization
- Study related complications
2.3.1 Response to CRT
- A positive response to CRT is defined by the following: Improvement in NYHA functional class by at least one grade
- Improvement in echocardiographic LVEF \& left ventricular end diastolic index (LVEDI)
- Improvement in patient global clinical assessment
- Improvement in 6-minute hall walk by 10%
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- heart failure patients indicated for the CRT-D therapy
Key inclusion criteria (5 listed)
- Referred for implantation of CRT-D according to currently accepted guidelines.
- 18 years or older
- Ability to independently comprehend and complete a QOL questionnaire
- Ability to provide informed consent for a study and be willing and able to comply with the prescribed follow-up
- Has stable conventional medications at least one month prior to enrollment
Key exclusion criteria (7 listed)
- Inability to successfully implant an intravascular lead CRT-D device. (i.e. exclude epicardial leads)
- Myocardial infarction or unstable angina in the last 3 weeks
- Chronic atrial fibrillation (continuous AF lasting > 1 Month) within 1 year prior to enrollment or having undergone cardioversion for AF in the past month
- 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 |
|---|---|---|
| Cardiac Resynchronization Therapy-DefibrillatorAlso: CRT-D deviceImplantation of a CRT-D device | Device | – |
Primary outcome
All Cause Death
Time frame: 1 year follow up
First Heart Failure Hospitalization
Time frame: 1 year follow up
1 secondary outcome
• Cause of death and ejection fraction
Time frame: 1 year follow up
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.
- Derived from this study: PubMed 25677851Shalaby AA, Abraham WT, Fonarow GC, Bersohn MM, Gorcsan J 3rd, Lee LY, Halilovic J, Saba S, Maisel A, Singh JP, Sonel A, Kadish A. Association of BNP and Troponin Levels with Outcome among Cardiac Resynchronization Therapy Recipients. Pacing Clin Electrophysiol. 2015 May;38(5):581-90. doi: 10.1111/pace.12610. Epub 2015 Mar 30.
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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.
Aala Shalaby, MD, FACC principal investigator
Veteran's Administration, Pittsburgh Healthcare System
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 Heart Failure, run by Abbott Medical Devices at 1 site 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 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: 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 1 site 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?
All Cause Death (time frame: 1 year follow up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00453622, which also lists 1 linked publication.
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.