Three-dimensional Assessment of Intraventricular Dyssynchrony Using Fast Dobutamine Gated SPECT (FAST DOGS)

January 31, 2017 updated by: University Hospital, Caen

The prognosis of patients with heart failure has improved due to recent breakthrough in medical treatment and cardiac resynchronization devices. However, there is no paraclinical parameter to assess response to cardiac resynchronization therapy (CRT). This is a major issue since about a third of implanted patients will not be improved by CRT. CZT SPECT allows to perform myocardial perfusion imaging in less than 4 minutes and is able to study myocardial perfusion, viability, left ventricular function, but also ventricular asynchrony.

Using low-dose dobutamine gated SPECT and CZT camera, we aimed to assess left ventricular dyssynchrony in viable segments in patients with heart failure eligible for CRT.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Caen, France, 14000
        • Service de Médecine Nucléaire du CHU de Caen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient with heart failure on optimal medical therapy and targeted for cardiac resynchronization therapy according to current recommendations;
  • Age over 18 years
  • Clinically stable (without hospitalization for heart failure in the last month)
  • Sinus rhythm
  • Social security insurance
  • Signed consent form

Exclusion Criteria:

  • Recent history (less than 21 days) of acute coronary syndrome or unstable angina;
  • Recent history (less than 1 month) of acute heart failure;
  • Right bundle branch block;
  • Irregular heart rate;
  • Double-chamber cardiac pacemaker
  • Patients previously implanted with a single-chamber cardioverter-defibrillator must have at least 99 percent of unstimulated QRS.
  • Countraindication to dobutamine therapy;
  • Valvular heart disease, congenital heart disease, hypertrophic cardiomyopathy;
  • Significant Ventricular arrhythmias;
  • Hypertension (upper than 160/100 mmHg);
  • Pregnant, breastfeeding or guardianship

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: myocardial perfusion scintigraphy
Low-dose dobutamine gated SPECT and CZT camera for the assessment of parameters of left ventricular dyssynchrony in heart failure patients eligible for the implantation of a cardiac resynchronization device.
Other: myocardial perfusion scintigraphy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
measures of dyssynchrony parameters
Time Frame: baseline
The primary endpoint is reproducible quantitative measures of dyssynchrony parameters between two successive acquisitions basal (entropy, bandwidth, standard deviation phase histogram).
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Caen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

July 22, 2015

First Submitted That Met QC Criteria

July 28, 2015

First Posted (Estimate)

July 29, 2015

Study Record Updates

Last Update Posted (Estimate)

February 1, 2017

Last Update Submitted That Met QC Criteria

January 31, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-176

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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