Effects of the Sodium-glucose Cotransporter 2 Inhibitors+Sacubitril/Valsartan Therapy in Patients With HFrEF.

NCT05934071 | Unknown FDA Drug

• 1 other identifier: 5428
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to investigate the effects of combination therapy with ARNI and inhibitors of SGLT2 in patients affected by HFrEF. The main questions it aims to answer are:

• What is the medium-long term impact of the ARNI + glyphozine combination therapy in terms of ventricular remodeling studied by speckle tracking echocardiography (GLS%) and by variation of volumetric indices and contractile function (LVEDV, LVEDD, FE%)?
• What is the medium-long term impact of the ARNI + glyphozine combination therapy in terms of variation of laboratory data indicative of heart failure (NT-pro-BNP)?
• What is the medium-long term impact of the ARNI + glyphozine combination therapy in terms of major cardiovascular events (MACVE)?
• What are the echocardiographic and laboratory parameters predictors of medium-long term major cardiovascular events (MACVE) and ventricular remodeling? Participants will undergo, at the time of enrollment and after approximately 3 and 12 months from the introduction of SGLT-2 inhibitor therapy, at clinical, echocardiographic and biohumoral investigations.

Conditions

Heart Failure; Ventricular Remodeling; Ventricular Dysfunction

Outcome Measures

Primary Outcomes (1)

• ventricular remodeling studied by speckle tracking echocardiography

  Evaluation of the medium-long term impact of the ARNI + glyphozine combination therapy in terms of ventricular remodeling studied through speckle tracking echocardiography and evaluated in terms of global longitudinal strain values (GLS%)

  3-12 months

Secondary Outcomes (4)

• variation of volumetric indices and contractile function

  3-12 months

• variation of laboratory data indicative of heart failure (NT-pro-BNP)

  3-12 months

• major cardiovascular events (MACVE)

  3-12 months

• echocardiographic and laboratory parameters predictors of medium-long term major cardiovascular events (MACVE) and ventricular remodeling

  3-12 months

Study Arms (1)

patients affected by HFrEF on ARNI

patients affected by HFrEF in optimized medical therapy including ARNI, eligible for glyphozine

Drug: SGLT2 inhibitor

Interventions

SGLT2 inhibitor DRUG

optimization of the medical therapy for heart failure with reduced ejection fraction with SGLT2 inhibitor, according to clinical guidelines

Also known as: Dapaglifozin, Empaglifozin

patients affected by HFrEF on ARNI

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

Patients affected by HFrEF on ARNI, eligible for glyphozine

You may qualify if:

• HFrEF on ARNI
• Ability to express written informed consent to participate in the study

You may not qualify if:

• Contraindication to glyphozine therapy (i.e., severe renal insufficiency with filtration estimated glomerular \<30ml/min/m2 or history of recurrent urinary tract infections);
• Comorbidities with expected survival of less than 1 year;
• Limited or legal inability to give written informed consent

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCSS

Roma, RM, 00168, Italy

RECRUITING

Biospecimen

Retention: NONE RETAINED

blood sample

MeSH Terms

Conditions

Heart Failure; Ventricular Remodeling; Ventricular Dysfunction

Interventions

Sodium-Glucose Transporter 2 Inhibitors

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Hypoglycemic Agents; Physiological Effects of Drugs

Study Officials

• NADIA ASPROMONTE, Prof.

  Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

NADIA ASPROMONTE, Prof.

CONTACT

00393477977895; nadia.aspromonte@policlinicogemelli.it

Study Design

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

Study Record Dates

• First Submitted: March 3, 2023
• First Posted: July 6, 2023
• Study Start: October 10, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: July 6, 2023

Record last verified: 2023-06

Locations

IT (1)