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Clinical Trials/NL-OMON35472
NL-OMON35472WithdrawnNot Applicable

The evaluation of the effect of S 44121 (ryanodine channel complex stabilizer) on MTWA in patients with chronic heart failure (CHF). - Calcium cycling dynamics and MTWA

Academisch Medisch Centrum0 sites5 target enrollmentStarted: TBDLast updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
Enrollment
5
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18 to 99 (—)

Inclusion Criteria

  • •-Male or female, Aged >=18 years and<= 85 years
  • •-Received an lCD for primary or secondary prevention of ventricular arrhythmia at least 3 months
  • •before selection,
  • •-Symptomatic chronic heart failure for at least 6 months before selection,
  • •-NYHA functional class I, II or Ill,
  • •-Stable condition with regards to heart failure symptoms for at least 4 weeks before selection,
  • •-Ischemic disease or idiopathic dilated cardiomyopathy as main cause for CHF,
  • •-Treated with optimal and unchanged CHF treatment and dosages for at least 4 weeks before
  • •-Treated with a maximal tolerated dosis beta-blocker for at least 3 months before selection
  • •(Patient can receive less than the daily target dose of the bela-blocker recommended in the ESC
  • •guidelines 2008)
  • •- Regular sinusal or atrial rhythm, paced or spontaneous, and provided that atrial contraction
  • •preceeds ventricular contraction

Exclusion Criteria

  • •-Women who are pregnant,
  • •-Women who are breast·feeding,
  • •-Women of childbearing potential not using estro-progestative or progestative or intra-uterine
  • •contraception, or women using estro-progestative or progestative or intra-uterine contraception,
  • •but who consider stopping it during the planned duration of the study,
  • •-Participation in another drug or device trial at the same time or during the 30 days prior to
  • •selection. Marketed drugs used for unapproved indications are considered to be investigational
  • •-Unstable condition within the previous 4 weeks before selection (e.g. documented hospital
  • •admission due to worsening of chronic heart failure)
  • •-Recent (less than 3 months before selection): myocardial infarction, unstable angina, coronary
  • •revascularisation,cerebral stroke or TIA
  • •- Severe valvular disease, congenital heart disease or pericardia! disease,
  • •-Scheduled surgery for valvular heart disease, for revascularisation (PC I or CABG),
  • •-Jntracardiac thrombus,
  • •-Active myocarditis,
  • •-Previous cardiac transplantation or on Jist for cardiac transplantation,
  • •-Cardiac resynchronisation therapy (CRT) started within the previous 3 months before selection,
  • •-Change in the anti-arrhythmic treatment or dose within the previous 4 weeks before selection,
  • •-Episode of reverted ventricular fibrillation or Torsade de Pointes in the last 4 weeks,
  • •-History of cardioversion or ablation for to treat atrial fibrillation or ventricular tachycardia in the
  • •previous 3 months before selection,
  • •-Atrio-ventricular block of second or third degree (documented on a resting ECG),
  • •-Corrected QT interval duration (Bazett's formula) > 480 ms,
  • •·Family history of long QT syndrome or congenital long QT syndrome,
  • •-INR < 1.4 or > 3.4 in patients taking anti-vitamin K oral anticoagulation,
  • •-Severe or uncontrolled hypertension (systolic blood pressure> 180 mmHg or diastolic blood
  • •pressure> 110 mmHg),
  • •-Unstable clinical condition or change in the CHF or anti-arrhythmic treatment or dosage since the
  • •selection visit,
  • •- Biological parameters: Sodium or Potassium out of range, creatinine > 200 ~molll, ALA T and/or
  • •ASAT > x3 ULN
  • •-Systolic blood pressure < 90 mmHg

Investigators

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