Congestive Heart FailureREFORMNCT00959179
The Registry Evaluating Functional Outcomes of Resynchronization Management
An observational study of Congestive Heart Failure, run by Saint Luke's Health System at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate the functional outcomes of resynchronization management and to describe the patient psychosocial characteristics (depression ad anxiety) and associated outcomes with electrophysiologic device therapy for chronic congestive heart failure. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Congestive Heart Failure
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2007to Dec 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Population from In-patient and out patient setting
Who may be able to join
- Patients implanted with ICD who meet Primary prevention (SCD-HeFT or MADIT II indications.
- Patients implanted with CRT-D indications (i.e. NYHA class III or IV; QRS > = to 120MS; LVEF <= TO 35%) patient willing to give informed consent and participate in follow up evaluation.
Who cannot join
- Non-English speaking patients and patients who are unable to give consent or participate in follow up protocols due to lack of a home phone or unwilling to disclose phone numbers.
- Patients with significant transient neurological impairment before, during or after device implant who have been deemed incompetent to complete the consent process, or who are unable to participate in follow-up evaluation tests.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Provena Saint Joseph Hospital
Elgin, Illinois, 60123
Oklahoma University Health Sciences Ctr.
Oklahoma City, Oklahoma
About this study
The purpose of this study is to evaluate the functional outcomes of resynchronization management and to describe the patient psychosocial characteristics (depression ad anxiety) and associated outcomes with electrophysiologic device therapy for chronic congestive heart failure.
Read the detailed description
This project will prospectively enroll all consecutive patients undergoing implantable cardioverter defibrillator (ICD) and ICD with biventricular pacemaker (CRT-D) implantation for heart failure from in-patient and out-patient setting. Primary objective: Compare the psychosocial function and quality of life of ICD patients to Patients receiving CRT-D therapy. Secondary outcome objectives: 1)Determine and compare the change in LVED (left ventricular end distolic) dimension and LVESV (left ventricular end systolic volume)from baseline to 9 month follow up in CRT and ICD patient.2)Determine and compare the change in NYHA (New York Heart Association) classification, KCCQ, optimisim and pessimism, degree of stress, and social support from baseline to 9 month follow up in CRT and ICD patients. Florida Patient Acceptance Survey and Florida Shock Anxiety Scale will be determined and compared at 3 monthe and 9 months.3)Determine and compare Clinical composite score(Packer M 2002)in patient groups where: Worsened-patient dies, improved, unchanged. Inclusion Criteria: Patient referred for device therapy (ICD or CRT-D) for chronic congestive heart failure who are willing and able to give informed consent and participate in follow-up calls. Duration of patient follow up will be 9 months. Statistical Mehtodology: Univariate, Multivariatae, Kaplan-Meier analysis
- Conditions
- Congestive Heart Failure
- Keywords
- CHF
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Device therapy patients for CHF. | enroll all consecutive patients undergoing implantable cardioverter defibrillator (ICD) and ICD with biventricular pacemaker (CRT-D) implantation for heart failure from in-patient and out-patient referral setting | |
| ICD and CRT-D patients | enroll all consecutive patients undergoing implantable cardioverter defibrillator (ICD) and ICD with biventricular pacemaker (CRT-D) implantation for heart failure from in-patient and out-patient referral setting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the psysocial function and quality of life of ICD patients receiving CRT with ICD therapy
Measured: 3 months and 9 month follow up
Secondary outcomes (1)
Compare change in LVED&LVESV in CRT and ICD patients. Determine/compare the change in NYHA class, KCCQ, optimism/pessimism, degree of stress,social support. Florida Shock Anxiety Scale & clinical composite score determined and compared at 3 and 9 month
Measured: 9 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2009 (estimated)
- Study startMay 2007
- Primary completionDec 2009 (estimated)
- Study completionDec 2009 (estimated)
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
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint Luke's Health System
- Sponsor type
- University, hospital or other
- Investigators
- Brian M Ramza, MD, Principal investigator, Cardiovascular Consultants PA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00959179
- Sponsor's protocol ID
- REFORM
- Acronym
- REFORM
- Status last verified
- Aug 2009
- First submitted
- 13 Aug 2009
- Last updated
- 14 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Registry Evaluating Functional Outcomes of Resynchronization Management
- ClinicalTrials.gov ID
- NCT00959179
- Acronym / sponsor ID
- REFORM / REFORM
- Conditions
- Congestive Heart Failure
- Keywords
- CHF
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Saint Luke's Health SystemUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 14 Aug 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.
The purpose of this study is to evaluate the functional outcomes of resynchronization management and to describe the patient psychosocial characteristics (depression ad anxiety) and associated outcomes with electrophysiologic device therapy for chronic congestive heart failure.
Detailed description
This project will prospectively enroll all consecutive patients undergoing implantable cardioverter defibrillator (ICD) and ICD with biventricular pacemaker (CRT-D) implantation for heart failure from in-patient and out-patient setting. Primary objective: Compare the psychosocial function and quality of life of ICD patients to Patients receiving CRT-D therapy. Secondary outcome objectives: 1)Determine and compare the change in LVED (left ventricular end distolic) dimension and LVESV (left ventricular end systolic volume)from baseline to 9 month follow up in CRT and ICD patient.2)Determine and compare the change in NYHA (New York Heart Association) classification, KCCQ, optimisim and pessimism, degree of stress, and social support from baseline to 9 month follow up in CRT and ICD patients. Florida Patient Acceptance Survey and Florida Shock Anxiety Scale will be determined and compared at 3 monthe and 9 months.3)Determine and compare Clinical composite score(Packer M 2002)in patient groups where: Worsened-patient dies, improved, unchanged. Inclusion Criteria: Patient referred for device therapy (ICD or CRT-D) for chronic congestive heart failure who are willing and able to give informed consent and participate in follow-up calls. Duration of patient follow up will be 9 months. Statistical Mehtodology: Univariate, Multivariatae, Kaplan-Meier analysis
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Device therapy patients for CHF. | – | –enroll all consecutive patients undergoing implantable cardioverter defibrillator (ICD) and ICD with biventricular pacemaker (CRT-D) implantation for heart failure from in-patient and out-patient referral setting |
| ICD and CRT-D patients | – | –enroll all consecutive patients undergoing implantable cardioverter defibrillator (ICD) and ICD with biventricular pacemaker (CRT-D) implantation for heart failure from in-patient and out-patient referral setting |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Population from In-patient and out patient setting
Key inclusion criteria (2 listed)
- Patients implanted with ICD who meet Primary prevention (SCD-HeFT or MADIT II indications.
- Patients implanted with CRT-D indications (i.e. NYHA class III or IV; QRS > = to 120MS; LVEF <= TO 35%) patient willing to give informed consent and participate in follow up evaluation.
Key exclusion criteria (2 listed)
- Non-English speaking patients and patients who are unable to give consent or participate in follow up protocols due to lack of a home phone or unwilling to disclose phone numbers.
- Patients with significant transient neurological impairment before, during or after device implant who have been deemed incompetent to complete the consent process, or who are unable to participate in follow-up evaluation tests.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Compare the psysocial function and quality of life of ICD patients receiving CRT with ICD therapy
Time frame: 3 months and 9 month follow up
1 secondary outcome
Compare change in LVED&LVESV in CRT and ICD patients. Determine/compare the change in NYHA class, KCCQ, optimism/pessimism, degree of stress,social support. Florida Shock Anxiety Scale & clinical composite score determined and compared at 3 and 9 month
Time frame: 9 month follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 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 M Ramza, MD principal investigator
Cardiovascular Consultants PA
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 Saint Luke's Health System 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 2 inclusion and 2 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 14 Aug 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. 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?
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?
Compare the psysocial function and quality of life of ICD patients receiving CRT with ICD therapy (time frame: 3 months and 9 month follow up). 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 14 Aug 2009.