EUCTR2005-004972-20-GR
Active, Not Recruiting
N/A
A Phase II Study to assess the hemodynamic effects of ISTAROXIME, a novel lusinotropic agent, in patients hospitalized with worsening heart failure and a reduced left ventricular systolic function. - The Horizon-HF Trial
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Chronic heart failure and left ventricular systolic dysfunction
- Sponsor
- Sigma-Tau i.f.r. S.p.A.
- Enrollment
- 120
- Status
- Active, Not Recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients will be enrolled in the study during the first 48 hours of hospitalisation (screening period).
- •Screening period inclusion criteria:
- •\- Capability of understanding the nature of the trial and willingness to participate as documented by signing the written informed consent form.
- •\- Male or female patients aged between 18 and 85 years.
- •\- Negative pregnancy test at screening, for women of childbearing potential only.
- •\- Body weight less than or equal to 100 kg.
- •\- Blood pressure not more than SAP150 or DAP 90 mmHg.
- •\- Heart rate in the range of 60\-110 bpm.
- •\- Adequate Echo window available.
- •\- Hospital admission to a monitored bed with a primary diagnosis of worsening of heart failure and Left Ventricular Ejection Fraction less than or equal to 35% documented by 2D\-Echocardiogram, or radionuclide angiography or LV angiogram within 6 months prior to screening or at hospitalisation.
Exclusion Criteria
- •\- Ongoing treatment with oral or intravenous inotropes and/or inodilators (amrinone, digoxin, dopamine, dobutamine, enoximone, levosimendan, milrinone). Patient treated with digoxin within the last week, can be randomised if the plasma concentration of digoxin are tested before randomisation and its value will be less than 0\.5 ng/ml.
- •\- Intermittent inotropes administration within 2 weeks.
- •\- Symptoms of Heart Failure at randomization e.g.: dyspnoea
- •\- Systolic blood pressure \< 90 mmHg.
- •\- Atrial fibrillation within 2 weeks.
- •\- Left Ventricular Bundle Branch Block
- •\- Cardiogenic shock.
- •\- Mechanical ventilation.
- •\- Creatinine level \> 3\.0 mg/dl or requiring dialysis treatment.
- •\- Left ventricular failure primarily from uncorrected obstructive valvular disease, hypertrophic obstructive cardiomyopathy, restrictive/obstructive cardiomyopathy, uncorrected thyroid disease, known acute myocarditis, known amyloid cardiomyopathy.
Outcomes
Primary Outcomes
Not specified
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