Predictives Factors of Cardiac Resynchronization Therapy: a Multimodal Analysis Using 2D Speckle Tracking Echocardiography Coupled With MIBG Myocardial Scintigraphy and Heart Failure Biomarkers

• Conditions: Heart Failure; Reduced Ejection Fraction
• Interventions: Other: cardiac resynchronisation therapy

• Registration Number: NCT02018029
• Lead Sponsor: University Hospital, Clermont-Ferrand

Brief Summary

Cardiac resynchronization therapy (CRT) is one of the lastest recommended treatments in patients with refractory symptomatic chronic heart failure with reduced ejection fraction (HFREF). Despite clear guidelines 20 to 40 % of implanted patients are not clinically ameliorated. They are called the "non responders". Patient selection seams to be one of the key to improve the efficiency of CRT. This protocol try to assess positive predictive factors to CRT by a multimodal approach.

Detailed Description

Cardiac resynchronization therapy (CRT) is a validated HFREF therapy. Unfortunately 20 to 40 % of implanted patients according to the guidelines do not have an improvement in their condition. The detection of "non responders" is imperfect. The selection of eligible patients to cardiac resynchronization is defined by symptomatic patients (NYHA class II to IV), a reduced Left Ventricle ejection fraction and by the duration of the left bundle branch block. No other parameter (clinical, electrical, echocardiographical) have been identified as positive predictive factor to cardiac resynchronization therapy.

The aim of the investigators study is to identify positive predictive parameters to CRT.

The investigators study included all patients eligible to CRT according to the guidelines of the European Society of Cardiology in four French centers (Clermont-Ferrand, Bordeaux, Nancy, Pasteur Toulouse).

1. At baseline a preimplantation evaluation is performed: clinical examination, laboratory assay (biological collection), echocardiography-2D Strain at rest and stress, myocardial perfusion scintigraphy and MIBG.

2. At 6 months, response to CRT is the primary endpoint. It is a composite primary endpoint, including modification of: Quality of Life Score (MINNESOTA scale) , NYHA functional status , 6-minute walk test and volume of the left ventricle. Three hundred patients are expected over a period of 24 months.

Study Timeline

• Study Start: 2013-03
• Status Verified: 2013-12
• Study First Submitted: 2013-12-17
• Study First Submitted QC: 2013-12-20
• Last Update Submitted: 2013-12-20
• Study First Posted: 2013-12-23
• Last Update Posted: 2013-12-23
• Primary Completion: 2015-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Patients over 18 year's old
• Patient eligible to CRT according guidelines of ESC 2012:

QRS ≥ 120 ms and LVEF ≤ 35% and appearance typical block left arm and NYHA III and IV in sinus rhythm, QRS ≥ 150 ms and LVEF ≤ 35 % non- appearance block left leg NYHA III and IV in sinus rhythm, QRS ≥ 130 ms and LVEF ≤ 30% and appearance typical of LBBB NYHA II

• Life expectancy expected to exceed one year with a good functional status
• Optimal pharmacological treatment of heart failure

Exclusion Criteria

• Pregnancy
• Contraindications to the CRT
• Fast atrial fibrillation
• Taking a treatment interfering with the binding of MIBG and can not be interrupted before the scan
• Contraindications to performing a scan [Hypersensitivity to the active substance (2-methoxy-isobutyl-isonitrile-(99mTc)and Iobenguane-(123l)) or any of the excipients, Pregnancy, Breastfeeding]
• Contraindication to achieve an uncontrolled stress test [Myocardial infarction in acute or very recent, unstable angina, prevent ventricular ejection (aortic stenosis, pulmonary stenosis, obstructive cardiomyopathy), severe hypertension, ventricular arrhythmia, and in all cases where it may be poorly tolerated : severe anemia , respiratory insufficiency, peripheral arterial disease, inability to walk or cycle ... ]
• No affiliation to the French social security system
• Refusal to participate
• Incapacity

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
cardiac resynchronisation therapy	cardiac resynchronisation therapy	-

Primary Outcome Measures

Name	Time	Method
Composite primary endpoint	day of inclusion	to evaluate response to CRT, modifications in NYHA class, 6-MWT, LV volumes and QOL scale.

Secondary Outcome Measures

Name	Time	Method
Mortality from any cause	at 6 months
Cardiovascular Mortality	at 6 months
Hospitalization for all causes	at 6 months
Mortality from heart failure	at 6 months
Hospitalization for other cardiac causes	at 6 months
Cardiac Transplantation	at 6 months
Hospitalization for heart failure	at 6 months
NYHA Class	at 6 months
Sudden Death recovered	at 6 months
Use of vasoactive amines	at 6 months
Test of 6-minute walk	at 6 months
Quality of life ( MINNESOTA )	at 6 months
Change in systolic and / or diastolic left ventricular volume greater than or equal to 15% off between the two periods	at 6 months

Trial Locations

Locations (1)

CHU de Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France