Overview

This trial is active, not recruiting.

Condition congestive heart failure
Sponsor Saint Luke's Health System
Start date May 2007
End date December 2009
Trial size 100 participants
Trial identifier NCT00959179, REFORM

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Arm
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
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

Primary Outcomes

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

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
time frame: 9 month follow up

Eligibility Criteria

Male or female participants from 18 years up to 90 years old.

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.

Additional Information

Official title The Registry Evaluating Functional Outcomes of Resynchronization Management
Principal investigator Brian M Ramza, MD
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
Trial information was received from ClinicalTrials.gov and was last updated in August 2009.
Information provided to ClinicalTrials.gov by Saint Luke's Health System.