Acute heart failure
Conditions
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or female = 18 years of age with body weight = 40 Kg and = 160 Kg - Systolic blood pressure =125 mmHg at the beginning of the screening period (after ICF signature) and at the end of the screening period (prior to randomization) - Admitted for AHF: Persistent dyspnea at rest or with minimal exertion, Pulmonary congestion assessed through physical examination and chest X-Ray - Furosemide at any time between admission and the start of screening - eGFR on admission: =25 and =75 mL/min/1.73 m2 Other protocol-defined inclusion criteria may apply. 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 700 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2483
Exclusion criteria
Exclusion criteria: - Dyspnea (non-cardiac causes) such as acute or chronic respiratory disorders or infections (i.e., severe chronic obstructive pulmonary disease, bronchitis, pneumonia), or primary pulmonary hypertension sufficient to cause dyspnea at rest, which may interfere with the ability to interpret the primary cause of dyspnea. - T >38.5°C - Clinical evidence of acute coronary syndrome - AHF due to arrhythmias, acute myocarditis or cardiomyopathy Other protocol-defined exclusion criteria may apply. Other protocol-defined exclusion criteria may apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): - Time to in-hospital Worsening of heart failure (WHF) requiring rescue therapy or all cause death through Day 5 post randomization. - Time will be computed in hours from randomization to the earlier of the events. ;Timepoint(s) of evaluation of this end point: Through Day 5 post randomization;Main Objective: Evaluate the time to in-hosptial Worsening of Heart Failure (WHF) requiring rescue therapy/all cause death.; Secondary Objective: - Evaluate the time to in-hospital WHF requiring rescue therapy/all cause death/readmission. - Evaluate the percentage of patients with persistent signs or symptoms of HF/ non-improvement - Evaluate the percentage of patients with renal deterioration. - Evaluate the length of stay. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Time to in-hospital Worsening of heart failure requiring rescue therapy as defined in the primary endpoint, or all cause of death or readmission for heart failure. Time will be computed in hours from randomization to the earlier of the events. - Percentage of patients with persistent symptoms or signs of Heart Failure / not showing an improvement versus baseline conditions (persisting need of IV therapy for HF). - Percentage of patients with renal deterioration, defined as = 0.3 mg/dL increase in serum creatinine. - Lengh of Stay (LOS). It will be defined as hours from the index hospitalization and the discharge. ; Timepoint(s) of evaluation of this end point: - All cause of death or readmission for heart failure and or renal failure will be evaluated through Day 14 post randomization. - Persistent symptoms or signs of HF / no improvement will be evaluated at 6, 12, 24 and 48 hours from start of drug infusion, daily through index hospitalization and through Day 5. - Renal deterioration will be evaluated at 24 and 48 hours from start of drug infusion, at Day 5 and at Day 14. - Length of stay will be evaluated through Day 30 post randomization. | — |
Countries
Austria, Belgium, Bulgaria, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Italy, Latvia, Lithuania, Norway, Poland, Portugal, Romania, Russian Federation, Serbia, Slovakia, Slovenia, Spain, Switzerland, United Kingdom
Contacts
Public ContactMedical Collaboration Centre
Novartis Pharmaceuticals UK Limited
Outcome results
None listed