Sodium NItroPrusside Treatment in Acute Heart Failure

NCT05027360 | Completed

• 1 other identifier: S_04_06_21_5186
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Acute Heart Failure

Keywords

Acute Heart Failure; sodium nitroprusside; NTproBNP

Outcome Measures

Primary Outcomes (1)

• NT-pro-BNP or BNP reduction

  Significant reduction (at least 25% from baseline levels) 48 hours after initiation of SNP infusion

  48 hours

Secondary Outcomes (4)

• Hospitalizations

  6 months

• Mortality

  30 days and 6 months

• Heart replacement therapies

  30 days and 6 months

• Intensive Care Unit

  through study completion, an average of 6 months

Study Arms (1)

Acute heart Failure AHF

AHF diagnosis, defined as rapid onset or worsening of symptoms and/or signs of HF

Drug: SNP - Sodium Nitroprusside

Interventions

SNP - Sodium Nitroprusside DRUG

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.

Acute heart Failure AHF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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, we plan to include approximately 300 patients.

You may qualify if:

• Age 18 years or older
• AHF diagnosis, defined as rapid onset or worsening of symptoms and/or signs of HF. According to a recently proposed new definition, HF is a clinical syndrome with current or prior Symptoms and or signs caused by a structural and/or functional cardiac abnormality (as determined by EF \<50%, abnormal cardiac chamber enlargement, E/E' \>15, moderate/severe ventricular hypertrophy or moderate/severe valvular obstructive or regurgitant lesion) and corroborated by at least one of the following: Elevated natriuretic peptide levels ; Objective evidence of cardiogenic pulmonary or systemic congestion by diagnostic modalities such as imaging (e.g. by chest X-ray or elevated filling pressures by echocardiography) or haemodynamic measurement (e.g. right heart catheterization, pulmonary artery catheter) at rest or with provocation (e.g. exercise).
• Intravenous SNP treatment

You may not qualify if:

• 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).

Sponsors & Collaborators

• Niguarda Hospital: lead

Study Sites (1)

ASST Grande Ospedale Metropolitano Niguarda

Milan, Italia, 20162, Italy

Location

Related Publications (1)

• Garatti L, Frea S, Bocchino PP, Angelini F, Cingolani M, Sacco A, Rondinara GM, Bagnardi V, Sala IM, Kapur NK, Colombo PC, De Ferrari GM, Morici N. Sodium nitroprusside in acute heart failure: A multicenter historic cohort study. Int J Cardiol. 2022 Dec 15;369:37-44. doi: 10.1016/j.ijcard.2022.08.009. Epub 2022 Aug 6.

  PMID: 35944767 DERIVED

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2021
• First Posted: August 30, 2021
• Study Start: June 1, 2021
• Primary Completion: October 15, 2021
• Study Completion: November 23, 2021
• Last Updated: November 24, 2021

Record last verified: 2021-11

Locations

IT (1)