The Registry Evaluating Functional Outcomes of Resynchronization Management

Congestive Heart Failure Clinical Trial

— REFORM  

Official title:

The Registry Evaluating Functional Outcomes of Resynchronization Management

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00959179
• Other study ID #: REFORM
• Status: Active, not recruiting
• Phase: N/A
• First received: August 13, 2009
• Last updated: August 13, 2009
• Start date: May 2007
• Est. completion date: December 2009

Study information

• Verified date: August 2009
• Source: Saint Luke's Health System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Locations

Country	Name	City	State
United States	Provena Saint Joseph Hospital	Elgin	Illinois
United States	Oklahoma University Health Sciences Ctr.	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Saint Luke's Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare the psysocial function and quality of life of ICD patients receiving CRT with ICD therapy		3 months and 9 month follow up	No
Secondary	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		9 month follow up	No