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

Not Applicable

Completed

• Conditions: Heart Failure
• Interventions: Other: myocardial perfusion scintigraphy

• Registration Number: NCT02510677
• Lead Sponsor: University Hospital, Caen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2015-07-22
• Study First Submitted QC: 2015-07-28
• Study First Posted: 2015-07-29
• Status Verified: 2017-01
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Last Update Submitted: 2017-01-31
• Last Update Posted: 2017-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
myocardial perfusion scintigraphy	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Service de Médecine Nucléaire du CHU de Caen; 🇫🇷 Caen, France