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

Heart Failure Clinical Trial

— FAST DOGS  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02510677
• Other study ID #: 12-176
• Status: Completed
• Phase: N/A
• First received: July 22, 2015
• Last updated: January 31, 2017
• Start date: June 2013
• Est. completion date: January 2017

Study information

• Verified date: January 2017
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Other:
• myocardial perfusion scintigraphy

Locations

Country	Name	City	State
France	Service de Médecine Nucléaire du CHU de Caen	Caen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	baseline