Clinical trial NCT02780180 (phase 2, status: terminated)
Conditions: heart failure
ICD codes: I50.814, I09.81, I50.82, I50.89, I50.9, T86.22, I11.0
Drugs: qgc001, placebo
SMILES: N[C@@H](CCS(O)(=O)=O)CSSC[C@@H](N)CCS(O)(=O)=O, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Reason stopped: 
    insufficient recruitment
  
Eligibility criteria:

        Inclusion Criteria:

          -  A signed and dated informed consent form prior to any study procedure

          -  Adult male subjects and female subjects without childbearing potential.

          -  Clinical diagnosis of CHF with history of NYHA class II-III for at least 3 months
             before randomisation.

          -  Documented left ventricular ejection fraction (LVEF) < 40% measured by any modality
             within the previous 12 months in the subject's medical history.

          -  Subjects must also have at least one local measurement of BNP level ≥ 300 pg/mL or
             NT-proBNP level ≥ 1200 pg/mL (preferred assay, local laboratory) at the screening
             visit (maximum 7 days before randomisation).

          -  eGFR > 30 mL/min/1.73 m2 (MDRD) at screening.

          -  Serum potassium < 5.0 mmol/L at screening.

          -  Systolic blood pressure < 110 mmHg (average of 3 consecutive measurements) at
             screening.

          -  Prescribed to optimal pharmacologic therapy per "ESC guidelines for the diagnosis and
             treatment of acute and chronic heart failure 2016", or based on the updated current
             clinical practice, unless contra-indicated or not-tolerated, and on a stable dose for
             at least 30 days prior to enrolment (the dosage of the drugs cannot be increased or
             decreased respectively by more than double or half of initial dosage).

          -  Taking oral loop diuretics at doses < 250 mg furosemide daily (or equivalent).

        Exclusion Criteria:

          -  BMI > 45 kg.m-2.

          -  Patients who require the use of HF IV therapy or oral furosemide > 250 mg (or
             equivalent) at any time during the 48 hours immediately before randomisation.

          -  Patients with unstable angina, myocardial infarction, PTCA, coronary artery bypass
             graft, cerebral vascular accident, or transient ischemic attack within previous 3
             months (90 days) before enrolment.

          -  Patients whose primary cause of heart failure is mitral or aortic valve disease or
             congenital heart disease or hypertrophic obstructive cardiomyopathy or infiltrative
             cardiomyopathy (e.g. amyloidosis, sarcoidosis) or myocarditis.

          -  Patients with "new" permanent atrial fibrillation (AF), discovered within 3 months
             prior to randomization.

          -  Heart rate > 110 beats/min at screening.

          -  Patients scheduled for Pacemaker (including ICD, CRT), Angioplasty, CABG or LVAD
             within the next 3 months.

          -  Patients with severe documented chronic obstructive lung disease (COPD), defined as
             chronic need for oxygen therapy

          -  eGFR < 30 mL/min/1.73 m2 (MDRD) at screening.

          -  Decrease in eGFR greater than 20% within 3 weeks prior to the screening visit.

          -  Serum potassium > 5.0 mmol/L at screening.

          -  Systolic blood pressure < 110 mmHg or with signs or symptoms of hypotension.

          -  Symptomatic hypotension or orthostatic hypotension defined by a decrease of systolic
             blood pressure of more than 30 mm Hg in the standing vs. sitting position at screening
             and at the basal SBP of the D0 (before having taken the study medication).

          -  A marked baseline prolongation of QT/QTc interval (e.g. repeated demonstrated of a QTc
             interval > 450 ms) AND QRS < 100 ms. In case of QRS enlargement > 100 ms (i-e bundle
             branch block, pacemakers) QT does not accurately reflect repolarization and may not be
             calculated.

          -  A history of additional risk factors for Torsade de Pointes (TdP) (e.g. hypokalemia,
             family history of long QT Syndrome).

          -  The use of concomitant medications that prolong the QT/QTc interval.

          -  Insulin-requiring diabetic patients (including type 1 Diabetes).

          -  History of angioneurotic edema.

          -  Severe liver failure at screening defined by a value of ALAT and/or ASAT≥ 5 from the
             normal value.

          -  Patients involved in any interventional clinical study, patients enrolled in
             Registries and/or in non-interventional studies may participate.

          -  Patients who take an investigational or non-approved treatment.

          -  Women of childbearing potential.

          -  Patients with a prior cardiac transplant or patients currently on the list for cardiac
             transplantation.

          -  Patient with hypersensitivity to the active substance or to one of the other
             components of the trial preparation.

          -  Patients in whom an allergy requiring chronic treatment is known or exists.

          -  Patients with a history of previous illnesses of neurological or psychiatric nature
             that affect the Central Nervous System.

          -  Patients with a life expectancy of less than 12 months per physician judgment.

          -  Frail patient who, in the opinion of the investigator will not be able to follow the
             protocol.