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

Primary Purpose

Heart Failure, Reduced Ejection Fraction

Status

Unknown status

Phase

Locations

France

Study Type

Observational

Intervention

cardiac resynchronisation therapy

About this trial

This is an observational trial for Heart Failure focused on measuring Heart failure, Cardiac Resynchronisation Therapy, collagen peptides, MIBG scintigraphy

Eligibility Criteria

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

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

Sites / Locations

CHU de Clermont-FerrandRecruiting

Arms of the Study

Arm 1

Arm Type

Arm Label

cardiac resynchronisation therapy

Arm Description

Outcomes

Primary Outcome Measures

Composite primary endpoint

to evaluate response to CRT, modifications in NYHA class, 6-MWT, LV volumes and QOL scale.

Secondary Outcome Measures

Mortality from any cause

Cardiovascular Mortality

Hospitalization for heart failure

Mortality from heart failure

Hospitalization for other cardiac causes

Hospitalization for all causes

Sudden Death recovered

Use of vasoactive amines

Cardiac Transplantation

Test of 6-minute walk

NYHA Class

Quality of life ( MINNESOTA )

Change in systolic and / or diastolic left ventricular volume greater than or equal to 15% off between the two periods

Full Information

NCT ID

NCT02018029

First Posted

December 17, 2013

Last Updated

December 20, 2013

Sponsor

University Hospital, Clermont-Ferrand

Collaborators

General Electrics France

1. Study Identification

Unique Protocol Identification Number

NCT02018029

Brief Title

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

Acronym

PREFAC-CRT

Official Title

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

Study Type

Observational

2. Study Status

Record Verification Date

December 2013

Overall Recruitment Status

Unknown status

Study Start Date

March 2013 (undefined)

Primary Completion Date

December 2015 (Anticipated)

Study Completion Date

December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Clermont-Ferrand

Collaborators

General Electrics France

4. Oversight

5. Study Description

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). 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. 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.

6. Conditions and Keywords

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

Heart Failure, Reduced Ejection Fraction

Keywords

Heart failure, Cardiac Resynchronisation Therapy, collagen peptides, MIBG scintigraphy

7. Study Design

Enrollment

300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

cardiac resynchronisation therapy

Intervention Type

Other

Intervention Name(s)

cardiac resynchronisation therapy

Primary Outcome Measure Information:

Title

Composite primary endpoint

Description

to evaluate response to CRT, modifications in NYHA class, 6-MWT, LV volumes and QOL scale.

Time Frame

day of inclusion

Secondary Outcome Measure Information:

Title

Mortality from any cause

Time Frame

at 6 months

Title

Cardiovascular Mortality

Time Frame

at 6 months

Title

Hospitalization for heart failure

Time Frame

at 6 months

Title

Mortality from heart failure

Time Frame

at 6 months

Title

Hospitalization for other cardiac causes

Time Frame

at 6 months

Title

Hospitalization for all causes

Time Frame

at 6 months

Title

Sudden Death recovered

Time Frame

at 6 months

Title

Use of vasoactive amines

Time Frame

at 6 months

Title

Cardiac Transplantation

Time Frame

at 6 months

Title

Test of 6-minute walk

Time Frame

at 6 months

Title

NYHA Class

Time Frame

at 6 months

Title

Quality of life ( MINNESOTA )

Time Frame

at 6 months

Title

Change in systolic and / or diastolic left ventricular volume greater than or equal to 15% off between the two periods

Time Frame

at 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 Population Description

All patient eligible to cardiac resynchronisation therapy

Sampling Method

Non-Probability Sample

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Patrick LACARIN

Phone

04 73 75 11 95

placarin@chu-clermontferrand.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Romain ESCHALIER

Organizational Affiliation

CHU de Clermont-Ferrand

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHU de Clermont-Ferrand

City

Clermont-Ferrand

ZIP/Postal Code

63003

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Patrick LACARIN

Phone

04 73 75 11 95

placarin@chu-clermontferrand.fr

12. IPD Sharing Statement

Learn more about this trial

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

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