Investigating the effects of a combination therapy for heart failure
Evaluation of the Effects of the Sodium-glucose Cotransporter 2 Inhibitors+Sacubitril/Valsartan Combined Therapy in Patients With HFrEF: an Echocardiographic Study.
Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT05934071
This study is testing if combining two heart medications can help people with heart failure feel better and improve their heart function over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 160 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS (other) |
| Locations | 1 site (Roma, RM) |
| Trial ID | NCT05934071 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the impact of combining ARNI therapy with SGLT2 inhibitors in patients with heart failure and reduced ejection fraction (HFrEF). It will assess medium to long-term effects on ventricular remodeling using echocardiography and laboratory markers indicative of heart failure. Participants will undergo evaluations at enrollment and again at approximately 3 and 12 months to measure changes in heart function and major cardiovascular events. The study seeks to clarify the mechanisms and benefits of this combination therapy in managing HFrEF.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with HFrEF who are currently on ARNI therapy and can provide informed consent.
Not a fit: Patients with contraindications to SGLT2 inhibitors or those with severe comorbidities limiting survival may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for patients with heart failure, potentially enhancing heart function and reducing cardiovascular events.
How similar studies have performed: While the combination of ARNI and SGLT2 inhibitors is a relatively novel approach, existing studies have shown promising results with SGLT2 inhibitors in heart failure management.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * HFrEF on ARNI * Ability to express written informed consent to participate in the study Exclusion Criteria: * 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
Where this trial is running
Roma, RM
- Fondazione Policlinico Universitario A. Gemelli IRCSS — Roma, RM, Italy (RECRUITING)
Study contacts
- Principal investigator: NADIA ASPROMONTE, Prof. — Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
- Study coordinator: NADIA ASPROMONTE, Prof.
- Email: nadia.aspromonte@policlinicogemelli.it
- Phone: 00393477977895
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Heart Failure, Ventricular Remodeling, Ventricular Dysfunction