Optimal patient Selection for CArdiac Resynchronisation Therapy using Molecular Imaging

Withdrawn

• Conditions: heart failure; Left ventricular dyssynchrony; 10019280

• Registration Number: NL-OMON38477
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 91

Inclusion Criteria

-Informed consent obtained
-Chronic heart failure;
-New York Heart Association functional class II, III or IV;
-QRS duration *150 ms for NYHA class II or *120 ms for NYHA class III/IV;
-Optimal pharmacological therapy;
-Left ventricular ejection fraction *35%.

Exclusion Criteria

-Contraindications for implantation of a CRT device;
-Age <18 years or incapacitated adult;
-Pregnancy;
-Severe aortic stenosis with a valve area or aortic valve replacement in history;
-Known allergic reaction to iobenguane;
-Participation in another clinical study that prohibits any procedures other than standard.

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>-99mTc-Tetrofosmin(MPS)-based dyssynchrony and infarct burden measurements<br /><br>-123I-metaiodobenzylguanidine(MIBG)-based Heart-to-Mediastinum(H/M)-ratio<br /><br><br /><br>The main study parameters will be compared to response to CRT as defined by:<br /><br>-Reduction in LVESV * 15%.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>-change in innervation and perfusion parameters after CRT<br /><br>-Infarct location as predictor of respons to CRT</p><br>