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

NCT ID: NCT01127334

Last Updated: 2012-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2010-05-31

Study Completion Date

2011-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Systolic Heart Failure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Adults age 18-110 years
2. Must have a CRT-D (A biventricular pacemaker with defibrillator)
3. Last optimization of their device (CRT-D) must not have been done in the past 3 months
4. 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

1. Less than 18 years of age or greater than 110 years old.
2. Does not have a CRT-D
3. Optimization of their device has occurred in the past 3 months
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Mississippi Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

University of Mississippi Medical Center

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Donny R. Stokes, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Mississippi Medical Center

John P. Payne, M.D.

Role: STUDY_DIRECTOR

University of Mississippi Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Mississippi Medical Center

Jackson, Mississippi, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2010-0069

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Pacing in Heart Failure With Preserved LVEF
NCT03215849 ENROLLING_BY_INVITATION NA