Risk Stratification and Benefits With Cardiac Resynchronization Therapy (CRT)

Heart Failure Clinical Trial

— BENEFIT  

Official title:

Risk Stratification and Benefits With Cardiac Resynchronization Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00996086
• Other study ID #: CRD 480
• Status: Completed
• Start date: February 2010
• Est. completion date: September 2012

Study information

• Verified date: February 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Ventricular Arrhythmias

Intervention

Device:
• CRT device implant
CRT device-recipients

Locations

Country	Name	City	State
United States	Touro College	New York	New York
United States	Veterans' Adminstration Pittsburgh Healthcare System	Pittsburgh	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Abbott Medical Devices	Northwestern University, VA Pittsburgh Healthcare System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in 6-minute hall walk distance between baseline and subsequent follow-up		12 months
Primary	Composite endpoint a. 6-minute hall walk distance b. NYHA Classification c. Quality of Life (Minnesota Living with Heart Failure, DASS, SF-36)		12 months
Primary	The occurrence of either death (all-cause) or first HF hospitalization.		12 months
Secondary	Quality of Life		12 months
Secondary	Change in echocardiographic variables including: a. Ejection Fraction b. Wall motion score c. Increase in TD velocity d. Yu index		12 months
Secondary	Cause-specific mortality		12 months