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

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
myocardial perfusion scintigraphy
Sponsored by
University Hospital, Caen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Service de Médecine Nucléaire du CHU de Caen

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

myocardial perfusion scintigraphy

Arm Description

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.

Outcomes

Primary Outcome Measures

measures of dyssynchrony parameters
The primary endpoint is reproducible quantitative measures of dyssynchrony parameters between two successive acquisitions basal (entropy, bandwidth, standard deviation phase histogram).

Secondary Outcome Measures

Full Information

First Posted
July 22, 2015
Last Updated
January 31, 2017
Sponsor
University Hospital, Caen
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1. Study Identification

Unique Protocol Identification Number
NCT02510677
Brief Title
Three-dimensional Assessment of Intraventricular Dyssynchrony Using Fast Dobutamine Gated SPECT
Acronym
FAST DOGS
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
myocardial perfusion scintigraphy
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
myocardial perfusion scintigraphy
Primary Outcome Measure Information:
Title
measures of dyssynchrony parameters
Description
The primary endpoint is reproducible quantitative measures of dyssynchrony parameters between two successive acquisitions basal (entropy, bandwidth, standard deviation phase histogram).
Time Frame
baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Service de Médecine Nucléaire du CHU de Caen
City
Caen
ZIP/Postal Code
14000
Country
France

12. IPD Sharing Statement

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Three-dimensional Assessment of Intraventricular Dyssynchrony Using Fast Dobutamine Gated SPECT

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