ASST Grande Ospedale Metropolitano Niguarda
Milan, Italia, 20162, Italy
NCT Number: NCT05027360
The primary objective of this multicentric observational retrospective study is to assess the efficacy and safety of SNP as part of the treatment regimen of AHF patients and to identify predictors of efficacy. The primary efficacy endpoint is brain natriuretic peptide (BNP) or N-terminal pro b-type natriuretic peptide (NT-proBNP) reduction (at least 25% from baseline levels) 48 hours after initiation of SNP infusion. AHF presentation (de novo or ADHF), systolic blood pression at presentation, left ventricle ejection fraction and dimension, entity of mitral regurgitation and central venous pressure will be evaluated in order to identify predictors of efficacy of SNP (in terms of primary endpoint).
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Notify Me18 year and older
All sexes
Observational
Milan, Italia, 20162, Italy
The present is a multicenter, observational, retrospective study. All consecutive patients admitted with a diagnosis of AHF to the Cardiothoracovascular Departments of the ASST Grande Ospedale Metropolitano Niguarda (Milan), ASST Ospedale Papa Giovanni XXIII (Bergamo) and Ospedale Le Molinette (Torino), and treated with intravenous SNP between January 2016 and January 2020 will be included, and medical records screened. Through the collaboration of the two joining institution, the investigator plan to include approximately 300 patients. Inclusion criteria are: age 18 years or older; AHF diagnosis, defined as rapid onset or worsening of symptoms and/or signs of HF; Intravenous SNP treatment. Exclusion criteria are: Age <18 years old; AHF after cardiac surgery; AHF complicated by cardiogenic shock requiring high dosage (defined as inotropic score >10) vasoactive agents and/or short-term extracorporeal life support (i.e. VA-ECMO, Impella). Inotropic score (IS) calculated as: dopamine dose (μg/kg/min) + dobutamine dose (μg/kg/min) + 100 × epinephrine dose (μg/kg/min) + 100 × norepinephrine dose (μg/kg/min) + 10 × phosphodiesterase 3 inhibitor dose (μg/kg/min). Invasive monitoring of central venous pressure (CVP) and arterial pressure may be present. The Swan Ganz pulmonary artery catheter for continuous haemodynamic monitoring will be rarely used. Simultaneous intravenous diuretics and concomitant inotropic agents with a maximun IS<20 administration will be tolerated. SNP will be administered intravenously by a continuous infusion at a dose of 0.2 up to 2 mcg/kg/min. Titration of SNP up to the maximum tolerated dose will be based on achieving decongestion, defined as decrease in CVP and reduction of pulmonary congestion, with a target mean arterial pressure of 65 to 70 mmHg. Headache or severe hypotension, as well as documented thiocyanate toxicity, will warrant discontinuation of SNP therapy. The primary objective of our study is to assess the efficacy and safety of SNP as part of the treatment regimen of AHF patients and to identify predictors of efficacy. The primary efficacy endpoint is brain natriuretic peptide (BNP) or N-terminal pro b-type natriuretic peptide (NT-proBNP) reduction (at least 25% from baseline levels) 48 hours after initiation of SNP infusion. Secondary endpoints include: Survival free from rehospitalization for HF at 6 months; 30-day and 6-month mortality; Composite of long-term LVAD implantation or HTx at 30 days and 6 months; Length of intensive care unit and total hospital stay. Safety endpoints are: thiocyanate toxicity, headache, severe hypotension requiring discontinuation of therapy, ventricular arrhythmias The investigators will evaluate the following baseline patients' characteristics in order to identify predictors of efficacy of SNP (in terms of primary endpoint): AHF presentation (de novo or ADHF); SBP at presentation (preserved, i.e. 90-140 mmHg; elevated, i.e. >140 mmHg; low, <90 mmHg); left ventricle ejection fraction (LVEF), graded as reduced (<40%), mid-range (40-49%) or preserved (≥50%); end-diastolic diameter (EDD); entity of mitral regurgitation (none/mild or moderate/severe mitral regurgitation); CVP (< 8 mmHg or ≥8 mmHg) Patient demographics, haemodynamics, laboratory values, echocardiographic parameters, adverse events and clinical outcomes will be obtained by complete chart review.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The primary objective of our study is to assess the efficacy and safety of SNP as part of the treatment regimen of AHF patients and to identify predictors of efficacy.
Time frame: 48 hours
Significant reduction (at least 25% from baseline levels) 48 hours after initiation of SNP infusion
Time frame: 6 months
Survival free from re-hospitalizations for heart failure
Time frame: 30 days and 6 months
All-cause mortality
Time frame: 30 days and 6 months
Composite of long-term LVAD implantation or HTx
Time frame: through study completion, an average of 6 months
Length of intensive care unit and total hospital stay
Niguarda Hospital
Other
Sodium NItroPrusside Treatment in Acute Heart Failure: Multicenter, Observational, Retrospective Study
Acronym: SNIP-AHF
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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