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

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WITHDRAWN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

PHASE2

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.

The purpose of this study is to assess the safety and efficacy of istaroxime in patients hospitalized for Acute Decompensated Heart Failure (ADHF) not requiring inotropic therapy.This will be done by comparing the hemodynamic effect of a 24-hour infusion of three different doses of the drug versus placebo. Efficacy will be measured as a change in Pulmonary Capillary Wedge Pressure from pre-infusion to 6 hours after infusion start. Secondary objectives will include the evaluation of clinical efficacy and safety through assessment of cardiovascular and renal tolerability as well as changes in biological markers such as brain natriuretic peptide (BNP) and troponin I (TNI), and the neurohormones renin and aldosterone and also to assess the pharmacokinetics of istaroxime and its metabolites.

Related Clinical Trials

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

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

NCT02617446

Acute Decompensated Heart Failure

COMPLETED PHASE2

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

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

NCT00869115

Heart Failure

WITHDRAWN PHASE1

A Study to Assess the Hemodynamic Effects, Safety, Tolerability, and Pharmacokinetics of Intravenous APD418 in Adult Participants With Heart Failure With Reduced Ejection Fraction

NCT05139615

Acute Heart Failure With Reduced Ejection Fraction

TERMINATED PHASE2

Study to Evaluate Effects of INL1 in Patients With Heart Failure and Reduced Ejection Fraction

NCT03875183

Heart Failure Reduced Ejection Fraction

UNKNOWN PHASE2

Detailed Description

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

The 32-day study includes a 48-hour screening period, a 30-minute to 2-hour pre treatment period, a maximum 2-hour period for randomization and measurement of baseline values, a 24-hour treatment period, and a 96-hour post-treatment period. A 25-day follow-up period including a visit on Day 30 will take place after the active phase of the study When considered to be eligible, a first cohort of 88 patients will be randomized in a 3:1 ratio to receive 24-hrs treatment with istaroxime 0.5 μg/kg/min or placebo. If after the continuous safety monitoring and interim analyses the DMC determines that there are no safety issues with this dose, a second cohort of 88 patients will be randomized in a 3:1 ratio to receive 24-hrs treatment with istaroxime 1.0 μg/kg/min or placebo. If after the continuous safety monitoring and interim analyses of the second cohort the DMC determines that there are no safety issues with this dose, a third cohort of 88 patients will be randomized in a 3:1 ratio to receive 24-hrs treatment with istaroxime 1.5 μg/kg/min or placebo. In all cohorts, patients will receive standard of care therapy.

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

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

Placebo

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

* Male or female patients ≥18 years;
* Admission for ADHF
* Systolic blood pressure ≤ 120 mmHg;
* Ejection fraction (EF) ≤ 35 %
* Signed informed consent.

* Persistence of ADHF signs despite initial treatment with i.v. diuretics and/or vasodilators;
* Cardiac index ≤ 2.5 L/min/m²;
* Pulmonary capillary wedge pressure ≥ 20 mmHg
* Systolic BP between 85 and 120 mmHg (limits included) without signs or symptoms of hypoperfusion

Exclusion Criteria

* Positive pregnancy test in females of childbearing potential;
* Systolic blood pressure \< 85 mmHg or \> 120 mmHg;
* Oral treatment with digoxin within one week before current hospitalization;
* Any inotrope administered during the current hospitalization
* Presence of cardiogenic shock or its occurrence within the past month;
* Acute coronary syndrome within the past 3 months;
* Coronary artery bypass graft or percutaneous coronary intervention within the past month;
* Stroke within the past 6 months;
* Atrial fibrillation with uncontrolled HR (HR \> 100 beats per minute (bpm);
* Life threatening ventricular arrhythmia or ICD (implantable cardioverter defibrillator) shock within the past month;
* Presence of a CRT (cardiac resynchronization therapy), ICD or pacemaker devices implanted within the past month;
* Second or third degree atrio-ventricular block without pacemaker;
* Abnormal safety lab values obtained within the last 24 hours of the screening period prior to pulmonary arterial catheter (PAC) insertion

* Any inotrope administered during the current hospitalization period
* Heart rate \> 120 bpm or \< 50 bpm;
* cTnI \> 0.5 ng/mL or cTnI \> ULN and \> 1.25x the first screening assessment

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No