An European study to assess safety and efficacy of a new drug in patients with worsening chronic heart failure

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 75

Inclusion Criteria

•Written informed consent will be obtained prior to any study procedure
•Adult male subjects and female subjects without childbearing potential = 80 years
•Clinical diagnosis of WHF who were New York Heart Association (NYHA) class II III at least 3 months prior to emergency presentation to hospital.
•Eligible subjects must be enrolled short before discharge or within 8 days after discharge from an episode of decompensated HF (index event) defined as
o(a) an overnight stay in a hospital, emergency department, or medical observation facility with the capability of treating with intravenous medications and observing HF patients, or
o(b) an unscheduled outpatient visit to a HF management centre, where parenteral therapy is required for HF stabilization.
•Documented left ventricular ejection fraction (LVEF) = 40% measured by any modality within the previous 6 months in the subject’s medical history
•Subjects must also have at least one local measurement of BNP level = 400 pg/mL or NT-proBNP level =1600 pg/mL (preferred assay, local lab) at any time during the index hospitalization or before randomization.
•eGFR = 60 mL/min/1.73 m2 (MDRD) at screening
•No decrease in eGFR greater than 20% from admission to the index hospitalisation and up to the randomisation day.
•Serum potassium = 5.0 mmol/L at screening
•Systolic blood pressure = 120 mmHg (average of 3 consecutive measurements)
•Prescribed to optimal pharmacologic therapy per ESC guidelines for the diagnosis and treatment of acute and chronic heart failure 2012”, or based on the updated current clinical practice, unless contra-indicated or not-tolerated, and on a stable dose (e.g., recommended not more than double or decrease in dosage) for at least 30 days prior to enrolment.
•Taking oral loop diuretics at doses = 250 mg furosemide daily (or equivalent)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 45
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

•Age > 80
•BMI > 35kg.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 persistent or permanent atrial fibrillation (AF) (per ACC/AHA/ESC 2006 guidelines for the management of patients with AF”) within 3 months (90days) prior to enrolment
•Patients scheduled for Pacemaker (including ICD, CRT), Angioplasty, CABG or LVAD within the next 3 months
•Patients with documented chronic obstructive lung disease.
•eGFR < 60 mL/min/1.73 m2 (MDRD) at screening
•Decrease in eGFR greater than 20% from admission to the index hospitalisation and up to the randomisation day
•Serum potassium > 5.0 mmol/L at screening
•Systolic blood pressure < 120 mmHg or with signs or symptoms of hypotension
•symptomatic hypotension or orthostatic hypotension defined by a decrease of more than 30 mm Hg in the standing vs. sitting position at screening and at T0 of the D0 (before having taken the study medication)
•Insulin-requiring diabetic patients (including type 1 Diabetes)
•HbA1c = 10% at screening visit
•History of angioneurotic edema
•Patients with a life expectancy of less than 12 months per physician judgment
•Patients involved in any concurrent clinical investigation
•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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Related Trials