Informations générales (source: ClinicalTrials.gov)
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)
Observational
University Hospital, Clermont-Ferrand (Voir sur ClinicalTrials)
mars 2013
décembre 2015
29 juin 2024
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.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHU de Clermont-Ferrand - 63003 - Clermont-Ferrand - France | Patrick LACARIN | Contact (sur clinicalTrials) | |||
Critères
Tous
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
- 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
- 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