G-STROPHANTHIN for Acute heart failure

Inclusion criteria

• {"criterion_text":"- 1.\tProvide written informed consent according to local regulations."}
• {"criterion_text":"- 2.\tMales and females aged > 18 years."}
• {"criterion_text":"- 3.\tUnplanned hospitalization or emergency department visit for AHF. Acute HF is defined as including all of the following criteria: •\tDyspnoea at rest in a recumbent sitting position (30 to 45 degrees), which has worsened within the past week. •\tRadiological evidence of HF on a chest X-ray (if an appropriate chest computerized tomography scan is done the X-ray need not be performed). •\tBrain natriuretic peptide (BNP) >500 pg/mL or NT-pro BNP >2000 pg/mL."}
• {"criterion_text":"- 4.\tSerum lactate level above or equal to 18.0 mg/dl (≥ 1.99 mmol/L)."}
• {"criterion_text":"- 5.\tEjection Fraction (EF) < 40% (echocardiography)."}
• {"criterion_text":"- 6.\tAbility to start the study drug administration within 12 h after initial clinical assessment."}
• {"criterion_text":"- 7.\tSystolic blood pressure ≥ 90 mmHg and ≤ 165 mmHg at the time of initial clinical assessment."}

Exclusion criteria

• {"criterion_text":"- 1.\tWomen of child-bearing potential (i.e., pre-menopausal women) and breast-feeding women without documentation of a negative blood pregnancy assay within 12 h prior to randomization."}
• {"criterion_text":"- 2.\tPatients with Heart Failure NYHA I and II."}
• {"criterion_text":"- 3.\tKnown active myocarditis, obstructive hypertrophic cardiomyopathy, congenital heart disease, restrictive cardiomyopathy, constrictive pericarditis, uncorrected clinically significant primary valvular disease."}
• {"criterion_text":"- 4.\tSerum lactate level below 18.0 mg/dl < 1.99 mmol/L."}
• {"criterion_text":"- 5.\tClinical diagnosis of acute coronary syndrome meeting any 2 of the following 3 criteria: •\tProlonged chest pain at rest, or an accelerated pattern of angina •\tElectrocardiogram changes indicative of ischemia or myocardial injury defined as: a new ST elevation at the J point of two anatomically contiguous leads with the cut-off points: ≥0.2 mV in men ≥40 years (>0.25 mV in men <40 years) or ≥0.15 mV in women in leads V2-V3 and/or ≥0.1 mV in other leads; or ST depression and T wave changes. New horizontal or down sloping ST depression ≥0.05 mV in two contiguous leads; and/or new T inversion ≥0.3 mV in two contiguous leads. •\tSerum troponin >3 times upper limit of normal."}
• {"criterion_text":"- 6.\tTerminal illness other than congestive HF with expected survival <180 days."}
• {"criterion_text":"- 7.\tClinically suspected acute mechanical cause of ADHF (e.g., papillary muscular rupture). The diagnosis need not be confirmed by imaging or cardiac catheterization."}
• {"criterion_text":"- 8.\tBody temperature ≥ 38°C just prior to randomization."}
• {"criterion_text":"- 9.\tAcute or chronic respiratory disorder (e.g., severe chronic obstructive pulmonary disease) or primary pulmonary hypertension sufficient to cause dyspnea at rest, which may interfere with the ability to interpret dyspnea assessments or hemodynamic measurements."}
• {"criterion_text":"- 10.\tCreatinine clearance <25 mL/min/1.73m² (as measured by the MDRD formula) at the time of screening."}
• {"criterion_text":"- 11.\tAnemia (hemoglobin <9 g/dL or a hematocrit <25%)"}
• {"criterion_text":"- 12.\tPatients with severe hepatic impairment."}
• {"criterion_text":"- 13.\tCurrent drug abuse or chronic alcoholism sufficient to impair participation and compliance to the study protocol."}
• {"criterion_text":"- 14.\tKnown vasculitis, active infective endocarditis, or suspected infections, e.g., pneumonia, acute hepatitis, systemic inflammatory syndrome, or sepsis."}
• {"criterion_text":"- 15.\tParticipation in an investigational clinical drug study within 30 days prior to randomization."}
• {"criterion_text":"- 16.\t Males and females aged < 18 years."}
• {"criterion_text":"- 17.\t Missing informed consent."}
• {"criterion_text":"- 18.\tAny condition that, in the Investigator's opinion, makes the patient unsuitable for study participation."}

Primary endpoints

• {"endpoint_text":"- Reduction of lactate during 90 minutes after first dose, reported as area under the curve.","definition_or_measurement_approach":"Lactate reduction measured over 90 minutes after first dose and reported as area under the curve (AUC)."}
• {"endpoint_text":"- Reduction of NT-proBNP 72 hours after first dose.","definition_or_measurement_approach":"NT-proBNP measured 72 hours after first dose."}

Secondary endpoints

• {"endpoint_text":"- Symptomatic and clinical improvement: a) Echocardiography (Visit 1 compared to Visit 6) b) Kansas City Cardiomyopathy Questionnaire (KCCQ-23): Visit 1 compared to Visit 10 and 11.","definition_or_measurement_approach":"Echocardiography comparisons between Visit 1 and Visit 6; KCCQ-23 comparisons between Visit 1 and Visits 10 and 11."}
• {"endpoint_text":"- Symptomatic and clinical improvement: Outcome differences NYHA III compared to NYHA IV, Duration of hospital stay, Mortality and Rate of Re-Hospitalisation","definition_or_measurement_approach":"Outcome differences by NYHA class (III vs IV), length of hospital stay, mortality, and rehospitalisation rate as measured during study follow-up."}

Germany

Earliest CTIS Part Ii Submission Date

21-11-2023

Latest Decision Or Authorization Date

04-03-2024

Processing Time Days

104

Number Of Sites

1

Number Of Participants

40

Primary sponsor

Full Name

Ananda Pharma GmbH

Organisation Type

Pharmaceutical company

Country Of Registered Address

Germany