Clinical Trials Logo
  1. Home
  2. Efficacy
  3. NCT05717257
  4. Details
NCT05717257 Clinical Trial

Dapagliflozin in Systemic Right Ventricle (DAPA-SERVE)

Efficacy Clinical Trial

— DAPA-SERVE  

Official title:
Safety and Efficacy of Dapagliflozin in Adult Patients With a Systemic Right Ventricle

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05717257
Other study ID # 001
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date August 1, 2022
Est. completion date August 2024

Study information
Verified date January 2023
Source Monaldi Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to describe safety and efficacy of Dapaglifozin in adults patients with a systemic right ventricle (congenitally corrected transposition of the great arteries or transposition of the great arteries following arterial switch procedure) and impaired systolic function of the systemic right ventricle.

Description:

This is a prospective double arm study aiming to describe safety and efficacy of Dapaglifozin in adults patients with a systemic right ventricle (congenitally corrected transposition of the great arteries or transposition of the great arteries following arterial switch procedure) and impaired systolic function of the systemic right ventricle. Dapagliflozin will be prescribed in a group of randomly selected patients in addition to the optimized medical therapy for heart failure with reduced ejection fraction. Changes in quality of life indicators, symptoms, biohumoral markers, exercise capacity and echocardiographic parameters of systolic right ventricular function will be evaluated in comparison with the control group, which will continue standard heart failure therapy.

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date August 2024
Est. primary completion date August 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age=18years - Optimal medical therapy or at least 3months - Systemic right ventricle ejection fraction=40%, assessed on echocardiography Exclusion Criteria: - Univentricular physiology - Systolic blood pressure<90mmHg - Glomerular filtration rate(GFR)<30ml/min

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Dapagliflozin 10mg Tab
Dapagliflozin 10 mg will be added on top of the standard optimized medical therapy for heart failure and reduced ejection fraction

Locations
Country Name City State
Italy Adult Congenital Heart Disease, Monaldi Hospital Naples

Sponsors (1)
Lead Sponsor Collaborator
Monaldi Hospital

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Adverse Events Absence of any suspected or confirmed adverse events or necessity of drug discontinuation 1 year
Primary Nt-proBNP 1 year
Primary Systemic right ventricle fractional area change 1 year
Primary Systemic right ventricle global longitudinal strain 1 year
See also
  Status Clinical Trial Phase
Not yet recruiting NCT00944268 - Efficacy and Tolerability Study to Treat Mild and Moderate Anxiety Phase 3
Completed NCT00504192 - A Phase II Study of Gemcitabine With Oxaliplatin as First Line Chemotherapy in Advanced Biliary Tract Cancer Phase 2
Recruiting NCT05580159 - New Generation mRNA Booster Vaccine Against Emerging VOCs Phase 3
Completed NCT05427305 - TAB008 Compared to Avastin® in Patients With EGFR Wild-type Non-squamous Non-small Cell Lung Cancer Phase 3
Active, not recruiting NCT05686161 - mRNA Booster Vaccine(SW-BIC-213) Compared With Pfizer andSinopharm Against Emerging VOCs Phase 3
Recruiting NCT06284746 - Tirelizumab Combined With Chemotherapy in the Treatment of HER-2 Negative Locally Advanced Gastric Cancer Phase 2
Completed NCT04260113 - Apatinib for Inoperable Advanced Chondrosarcoma N/A
Recruiting NCT06120712 - A Phase Ⅰb Study on Autologous GC101 TIL Injection for the Treatment of Advanced Melanoma (MIZAR-002) Phase 1/Phase 2
Active, not recruiting NCT04002440 - Directed Use of REmote Patient Management System AMia to Achieve Prescribed Dry Weight N/A
Recruiting NCT02693587 - Misodel or Angusta for Induction of Labour? N/A
Completed NCT01194453 - Pemetrexed Plus Cisplatin Versus Gemcitabine Plus Cisplatin for Advanced NSCLC Metastatic Non-small Cell Lung Cancer Phase 2
Recruiting NCT05276557 - PyloPlus Urea Breath Test System Pediatric Safety and Efficacy Study Phase 3
Recruiting NCT06205758 - Efficacy and Safety Prediction of Milrinone or Levosimendan as Initial Inotropic Drug Therapy in Patients With Acute and Advanced Heart Failure With Renal Insufficiency
Recruiting NCT06122454 - A Phase Ic/IIb Study to Evaluate the Efficacy，Safety and Pharmacokinetics of HST in Patients With CHB Phase 1/Phase 2
Recruiting NCT05913271 - Study on the Correlation Between NAT2(N-acetyltransferase2) Gene Polymorphism and CrCl(Creatine Clreance) and the Efficacy and Safety of Levosimendan in Patients With Severe Heart Failure
Recruiting NCT05999656 - Human Cord Blood Mononuclear Cells in the Treatment of Refractory Diabetic Foot N/A
Recruiting NCT05731258 - Observational of Adjuvant Treatment of Breast Cancer With Liposomal Doxorubicin Regimen
Recruiting NCT03908138 - RDD Versus VDD in Newly Diagnosed Patients With Multiple Myeloma Phase 4
Completed NCT05648799 - Pharmacokinetics, Safety and Efficacy Study of GP30341 (GEROPHARM, Russia) in Healthy Volunteers and Outpatients With COVID-19 N/A
Recruiting NCT03377933 - The Effects Probiotic Has on Gastromicroecology and Combined With Quadruple Regimen for H Pylori Infection N/A