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

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

Status
Unknown
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON35472
Enrollment
5
Registered
2011-11-08
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

arrhythmia heart failure reduced heart function

Interventions

None listed

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: -Male or female, Aged >=18 years and

Exclusion criteria

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 drugs, -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 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

Design outcomes

Primary

MeasureTime frame
Alteration in presence or absence of MTWA before and after drug admission.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)