Pilot Study Using Echocardiography to Evaluate Patients W... | NCT01127334

Studies
Pilot Study Using Echocardiography to Evaluate Patients With Heart Failure and Dyssynchrony Who Have a CRT-D Device

NCT01127334

Sponsor

University of Mississippi Medical Center

Status

Withdrawn

Last Update Posted

Apr 4, 2012Estimated

Enrollment

0Actual

Phase

Not provided

Conditions

Systolic Heart Failure

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2010

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Principal Investigator terminated study

Expanded Access Info

Start Date

May 2010

Primary Completion Date

May 2011Actual

Completion Date

May 2011Actual

First Submitted Date

May 19, 2010

First Submission Date that Met QC Criteria

May 19, 2010

First Posted Date

May 20, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 2, 2012

Last Update Posted Date

Apr 4, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Out of all the patients that receive a CRT-D ( a dual chamber pacemaker with defibrillator ) for cardiac resynchronization therapy there is approximately one-third that do not respond. We believe that by using a simple technique that includes routine echocardiography that are normally performed in these patients could help us better understand how to program their device to reach better optimization.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Systolic Heart Failure, Dyssynchrony, CRT-D		Patients with systolic heart failure and dyssynchrony that have a CRT-D that have not been optimized in the past 3 months.

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adults age 18-110 years
Must have a CRT-D (A biventricular pacemaker with defibrillator)
Last optimization of their device (CRT-D) must not have been done in the past 3 months
Must be optimal heart failure medical regimen. This includes target dose of beta-blocker and angiotensin converting enzyme inhibitor (ACE-I) (or equivalent; i.e angiotensin receptor blocker (ARB); or balanced preload and afterload reducers with hydralazine and nitrates.)

Exclusion Criteria:

Less than 18 years of age or greater than 110 years old.
Does not have a CRT-D
Optimization of their device has occurred in the past 3 months
Not on optimal medical therapy for heart failure as listed in the inclusion criteria.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Cardiology and electrophysiology clinics

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Donny R. Stokes, M.D.	University of Mississippi Medical Center	Principal Investigator
John P. Payne, M.D.	University of Mississippi Medical Center	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Mississippi Medical Center		Jackson	Mississippi	39216	United States

Condition Browse Module

MeSH Terms

ID	Term
D054143	Heart Failure, Systolic

Ancestor Terms

ID	Term
D006333	Heart Failure
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided