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

NCT02018029 | Unknown

• 1 other identifier: CHU-0173
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; Reduced Ejection Fraction

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Composite primary endpoint

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

  day of inclusion

Secondary Outcomes (13)

• Mortality from any cause

  at 6 months

• Cardiovascular Mortality

  at 6 months

• Hospitalization for heart failure

  at 6 months

• Mortality from heart failure

  at 6 months

• Hospitalization for other cardiac causes

  at 6 months

Study Arms (1)

cardiac resynchronisation therapy

Other: cardiac resynchronisation therapy

Interventions

cardiac resynchronisation therapy OTHER

cardiac resynchronisation therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patient eligible to cardiac resynchronisation therapy

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• General Electrics France: collaborator

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

MeSH Terms

Conditions

Heart Failure

Interventions

Cardiac Resynchronization Therapy

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Pacing, Artificial; Electric Stimulation Therapy; Therapeutics

Study Officials

• Romain ESCHALIER

  CHU de Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick LACARIN

CONTACT

04 73 75 11 95; placarin@chu-clermontferrand.fr

Study Design

• Study Type: observational
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2013
• First Posted: December 23, 2013
• Study Start: March 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 23, 2013

Record last verified: 2013-12

Locations

FR (1)