Clinical trial NCT00959179: The Registry Evaluating Functional Outcomes of Resynchronization Management
Official title: The Registry Evaluating Functional Outcomes of Resynchronization Management
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Congestive Heart Failure
Keywords: CHF
Lead sponsor: Saint Luke's Health System
Sponsor class: OTHER
First posted: 2009-08-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Population from In-patient and out patient setting

Brief 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.

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

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Compare the psysocial function and quality of life of ICD patients receiving CRT with ICD therapy
timeFrame: 3 months and 9 month follow up
Secondary outcomes:
measure: 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
timeFrame: 9 month follow up
Other outcomes:
Locations:
city: Elgin
country: United States
facility: Provena Saint Joseph Hospital
state: Illinois
city: Oklahoma City
country: United States
facility: Oklahoma University Health Sciences Ctr.
state: Oklahoma
Study officials:
affiliation: Cardiovascular Consultants PA
name: Brian M Ramza, MD
role: PRINCIPAL_INVESTIGATOR
References: