The Registry Evaluating Functional Outcomes of Resynchronization Management (REFORM)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Saint Luke's Health System.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Saint Luke's Health System
ClinicalTrials.gov Identifier:
NCT00959179
First received: August 13, 2009
Last updated: NA
Last verified: August 2009
History: No changes posted
  Purpose

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.


Condition
Congestive Heart Failure

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Registry Evaluating Functional Outcomes of Resynchronization Management

Resource links provided by NLM:


Further study details as provided by Saint Luke's Health System:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: May 2007
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Population from In-patient and out patient setting

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00959179

Locations
United States, Illinois
Provena Saint Joseph Hospital
Elgin, Illinois, United States, 60123
United States, Oklahoma
Oklahoma University Health Sciences Ctr.
Oklahoma City, Oklahoma, United States
Sponsors and Collaborators
Saint Luke's Health System
Investigators
Principal Investigator: Brian M Ramza, MD Cardiovascular Consultants, PA
  More Information

No publications provided

Responsible Party: Dr. Brian M. Ramza, Saint Luke's Hospital
ClinicalTrials.gov Identifier: NCT00959179     History of Changes
Other Study ID Numbers: REFORM
Study First Received: August 13, 2009
Last Updated: August 13, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Saint Luke's Health System:
CHF

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 18, 2014