Phase I Interaction Study of Istaroxime and Digoxin in Subjects With Stable Heart Failure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study explores a potential drug-drug interaction between istaroxime and digoxin in patients with stable CHF on chronic oral digoxin treatment.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Safety and Efficacy Study of Istaroxime in Acute Decompensated Heart Failure Patients

NCT00838253

Heart Failure

WITHDRAWN PHASE2

The Clinical Study of the Safety and Efficacy of Istaroxime in Treatment of Acute Decompensated Heart Failure

NCT02617446

Acute Decompensated Heart Failure

COMPLETED PHASE2

Study to Evaluate the Effect of Solifenacin and Mirabegron on the Digoxin Concentrations in Blood in Healthy Subjects

NCT02127034

Healthy Subjects Pharmacokinetics Drug-Drug Interaction (DDI)

COMPLETED PHASE1

A Phase II Trial to Assess Hemodynamic Effects of Istaroxime in Pts With Worsening HF and Reduced LV Systolic Function

NCT00616161

Heart Failure

COMPLETED PHASE2

Digoxin Versus Ivabradine in Heart Failure With Reduced Ejection Fraction

NCT02046044

Heart Failure

UNKNOWN PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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 three cohorts (I to III) of 16 patients each (12 patients on istaroxime and 4 patients on placebo). Digoxin will be administered non blinded in all patients, once daily in the morning after a standardized breakfast, continuing with previously personalized dosage schedule during the screening period, treatment period, post treatment period and follow up period. Prior to accrual of cohorts II and III, a Data Monitoring Committee (DMC) will advise on the continuation to the next istaroxime dose, based on a predetermined safety review.

This 37 day study includes a screening period (Days -21 to -1), a treatment period (Day 1), a post treatment period (Days 2-4), and a follow up period (which includes one patient visit on Day 14). Patients will be confined in the phase I research center from Day -2 to Day 4.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Heart Failure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

TREATMENT 0.5 μg/kg/min

Group Type EXPERIMENTAL

Istaroxime

Intervention Type DRUG

Istaroxime 0.5 μg/kg/min (30 μg/kg/h) continuous i.v. infusion for 24 hours

2

TREATMENT 1.0 μg/kg/min

Group Type EXPERIMENTAL

Istaroxime

Intervention Type DRUG

Istaroxime 1.0 μg/kg/min (60 μg/kg/h) continuous i.v. infusion for 24 hours

3

TREATMENT 1.5 μg/kg/min

Group Type EXPERIMENTAL

Istaroxime

Intervention Type DRUG

Istaroxime 1.5 μg/kg/min (90 μg/kg/h) continuous i.v. infusion for 24 hours

4

PLACEBO

Group Type PLACEBO_COMPARATOR

Istaroxime

Intervention Type DRUG

Placebo continuous i.v. infusion for 24 hours

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Istaroxime

Istaroxime 0.5 μg/kg/min (30 μg/kg/h) continuous i.v. infusion for 24 hours

Intervention Type DRUG

Istaroxime

Istaroxime 1.0 μg/kg/min (60 μg/kg/h) continuous i.v. infusion for 24 hours

Intervention Type DRUG

Istaroxime

Istaroxime 1.5 μg/kg/min (90 μg/kg/h) continuous i.v. infusion for 24 hours

Intervention Type DRUG

Istaroxime

Placebo continuous i.v. infusion for 24 hours

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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 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;

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No