Status:
WITHDRAWN
Phase I Interaction Study of Istaroxime and Digoxin in Subjects With Stable Heart Failure
Lead Sponsor:
Debiopharm International SA
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This study explores a potential drug-drug interaction between istaroxime and digoxin in patients with stable CHF on chronic oral digoxin treatment.
Detailed Description
This is a single center, randomized, double blind, placebo controlled, escalating dose phase I interaction study. The three dose levels of istaroxime or placebo will be randomized sequentially to thre...
Eligibility Criteria
Inclusion
- Main screening inclusion criteria :
- Signed informed consent;
- Male or female patients ≥18 years;
- Female patients of childbearing potential must not be pregnant;
- Chronic stable cardiac function impairment (no change in heart failure medication over the last 3 months and without any dosage adjustment in the last 4 weeks);
- Systolic blood pressure (SBP) of ≥ 90 mmHg and ≤ 140 mmHg;
- LVEF ≤ 35% by any method (to be performed at screening if not measured within the last 12 months);
- Chronic treatment (i.e. once daily dosing without interruption) with oral digoxin started at least 3 months prior to study entry and without any concomitant administration of other positive inotropic drugs;
Exclusion
- Main screening exclusion criteria :
- Need for current or intermittent intravenous positive inotrope administration within the preceding 6 months, or hemodynamic support devices;
- Acute coronary syndrome within the past 3 months;
- Coronary artery bypass graft or percutaneous coronary intervention within the past 3 months;
- Stroke within the past 6 months;
- Atrial fibrillation or uncontrolled heart rate (HR) (\> 100 beats per minute \[bpm\]);
- Significant arrhythmia or second or third degree atrio-ventricular block;
- Valvular disease as the primary cause of HF;
- Significant ECG abnormalities as assessed by appropriately qualified physician or investigator including QTcF \>450;
- Positive testing for Human Immunodeficiency Virus (HIV), Hepatitis B and/or Hepatitis C;
- Main randomization exclusion criteria:
- HR \> 100 bpm or \< 50 bpm;
- Serum potassium \> 5.3 mmol/L or \< 3.8 mmol/L and magnesium \> 1.1 mmol/L or \< 0.6 mmol/L,
- TN I \> ULN.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00869115
Start Date
June 1 2009
Last Update
October 23 2014
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