Clinical trial NCT00996086: Risk Stratification and Benefits With Cardiac Resynchronization Therapy (CRT)
Official title: Risk Stratification and Benefits With Cardiac Resynchronization Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Ventricular Arrhythmias
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
Collaborators: name: Northwestern University
name: VA Pittsburgh Healthcare System
First posted: 2009-10-16
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who undergo implantation of a market-approved St. Jude Medical CRT defibrillator (CRT-D) and a compatible lead system may be included in the study.

Brief summary: This is an observational study to learn which patients benefit from CRT therapy and to track the clinical changes that help identify the risk-level of CRT patients.

Detailed description: The purpose of the study is two-fold. First, to determine if an algorithm can be developed based on pre-implant clinical variables to predict response to CRT-D therapy. Second, the study aims to determine in patients implanted with CRT-D if the combined use of cTnT and BNP can further predict and risk-stratify HF improvement and all-cause mortality. Additionally, novel biochemical markers defining cardiac mortality in high risk patients detected by plasma proteomic analysis in the CRT-D patients will be evaluated.

This study represents a combination of previous CRT studies that evaluated these variables independently. Data from this study will be pooled with data from previous studies to build a more complete picture of CRT therapy.

Eligibility criteria: Inclusion Criteria:

* Meets current clinical indications for CRT-D therapy
* Patient is 18 years old or older
* Ability to independently comprehend and complete all QOL questionnaires
* Patient has the ability to perform the 6-minute Hall Walk Test (6-MHW) with the only limiting factor being fatigue or shortness-of-breath
* Ability to provide informed consent for a study and be willing and able to comply with the prescribed follow-up

Exclusion Criteria:

* Inability to successfully implant an intravascular lead and CRT-D device. (i.e. exclude epicardial leads) within 30 days of initial procedure.
* Myocardial infarction in the last 3 weeks
* Unstable angina in the last 3 weeks
* Status 1 classification for cardiac transplantation
* Currently participating in a clinical trial that includes an active treatment arm
* Life expectancy of less than 12 months.
* Recent (within 1 week) administration of Nesiritide™ or inotropes
* Patients in whom revascularization is expected
* Patient is pregnant

Primary outcomes:
measure: Change in 6-minute hall walk distance between baseline and subsequent follow-up
timeFrame: 12 months
measure: Composite endpoint a. 6-minute hall walk distance b. NYHA Classification c. Quality of Life (Minnesota Living with Heart Failure, DASS, SF-36)
timeFrame: 12 months
measure: The occurrence of either death (all-cause) or first HF hospitalization.
timeFrame: 12 months
Secondary outcomes:
measure: Quality of Life
timeFrame: 12 months
measure: Change in echocardiographic variables including: a. Ejection Fraction b. Wall motion score c. Increase in TD velocity d. Yu index
timeFrame: 12 months
measure: Cause-specific mortality
timeFrame: 12 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Touro College
state: New York
city: Pittsburgh
country: United States
facility: Veterans' Adminstration Pittsburgh Healthcare System
state: Pennsylvania
Study officials:
affiliation: Northwestern University
name: Alan Kadish, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: VA Pittsburgh Healthcare System
name: Alaa Shalaby, M.D.
role: PRINCIPAL_INVESTIGATOR
References: