Clinical trial NCT00616161 (phase 2, status: completed)
Conditions: heart failure
ICD codes: I50.814, I09.81, I50.82, I50.89, I50.9, T86.22, I11.0
Drugs: istaroxime, istaroxime, istaroxime, placebo
SMILES: C[C@]12CC[C@H]3[C@@H](CC(=O)[C@H]4C\C(CC[C@]34C)=N\OCCN)[C@@H]1CCC2=O, C[C@]12CC[C@H]3[C@@H](CC(=O)[C@H]4C\C(CC[C@]34C)=N\OCCN)[C@@H]1CCC2=O, C[C@]12CC[C@H]3[C@@H](CC(=O)[C@H]4C\C(CC[C@]34C)=N\OCCN)[C@@H]1CCC2=O, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          -  Signing of a written informed consent form.

          -  Male or female patients aged between 18 and 85 years.

          -  Negative pregnancy test at screening, for women of childbearing potential.

          -  Body weight less or equal to 100 kg.

          -  Blood pressure not more than SAP=150 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 LV Ejection Fraction less or equal to 35% documented by 2D-Echocardiogram,
             or radionuclide angiography or LV angiogram within 6 months prior to screening or at
             hospitalization.

          -  the clinical condition of the patient are stabilized within 48 hours from
             hospitalization and do not require continuous iv drug treatments

          -  no need for additional new oral treatments or any intravenous treatment administration
             over the following 8 hours is foreseen

        Randomisation period inclusion criteria:

          -  Any residual sign of heart failure (e.g.: Jugular Venous Distension, and/or Rales
             and/or Peripheral Oedema) associated with a PCWP more or equal to 20 mmHg,

          -  The last three consecutive determinations of PCWP, obtained during the stabilization
             period, have to be in a maximum range of variability of 10%.

        Exclusion Criteria:

          -  Ongoing treatment with oral or intravenous inotropes and/or inodilators.

          -  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 or 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.

          -  Artificial heart valve.

          -  Electrical device implanted (ICD, CRT)

          -  Evidence of acute coronary syndrome within 3 months.

          -  History of stroke or transient ischemic attack in the 6 months prior to screening.

          -  History of sustained ventricular tachycardia.

          -  Coronary by-pass grafting or PTCA within the last 30 days

          -  INR > 1.5.

          -  Status post successful cardiac resuscitation.

          -  Serum K < 3.5 mEq/l or > 5.3 mEq/l just prior to treatment.

          -  ALT, AST > 3 times the upper normal limit just prior to treatment.

          -  Hemoglobin < 10 g/dl (either gender) just prior to treatment.

          -  Other clinically significant laboratory or medical conditions, which in the opinion of
             the Investigator make the patient unsuitable for evaluation in the study.

          -  Anticipated survival of less than 2 months for concomitant diseases.