DApagliflozin Cardiovascular Effects on Patients at End-stage REnal Disease

End-stage Kidney Disease Clinical Trial

— Dare-Esrd  

Official title:

Dapagliflozin Cardiovascular Effects on Patients at End-stage Renal Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05685394
• Other study ID #: 30
• Status: Recruiting
• Phase: Phase 4
• Start date: January 24, 2023
• Est. completion date: December 1, 2024

Study information

• Verified date: November 2023
• Source: University of Campinas, Brazil
• Contact: Joaquim Barreto, MD
• Phone: +55 19 3521 7959
• Email: joaquimbarretoantunes[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Treatment with sodium glucose co-transporter type 2 inhibitors (Sglt2i) reduced the incidence of cardiovascular death and hospitalization for heart failure by 29% in individuals with moderate chronic kidney disease. Recent observations found that beyond its effect on natriuresis, Sglt2i directly interacts with cardiomyocytes inducing improvement of myocardial function. This effect is not mitigated as glomerular filtration rate declines. Therefore, plausibly treatment with Sglt2i may attenuate heart failure in individuals end-stage kidney disease (ESKD) requiring dialysis, in whom cardiovascular disease remains the leading cause of death.

In this context, this project was designed to estimate the effect of dapagliflozin on myocardial function of dialysis subjects. Individuals with diagnosed ESKD on dialysis for at least 3 months, from both sexes, aged more than 18 years of age are eligible. Exclusion criteria are pregnant woman, hepatic failure, and known allergy to study medications. Eligible patients will be recruited from the Nephrology Division of the Clinics Hospital of the University of Campinas (Unicamp). The study was designed as a prospective, randomized, open-label, phase 4 clinical trial. Patients will be randomized, 1:1, for a 6-months treatment with either dapagliflozin 10mg/day (n=40) add to standard treatment or standard treatment alone (n=40). At the randomization visit, all patients will undergo a detailed interview and medical examination by the physician-researcher, echocardiogram and blood samples will be collected for further biochemical analysis and follow up visits will be scheduled every month for endpoints disclosure and medications dispensation until the end of study participation at the 6th month visit when echocardiogram and blood sample collection will be repeated.

Primary goal will be the difference between groups in mean change of NTproBNP levels during treatment. Secondary endpoints encompass the mean change in ejection fraction, e/e' ratio, global longitudinal and radial strain and indexed left ventricle mass. Changes in bone metabolsm and structure, assessed by serum levels of FGF-23 and α-Klotho, and changes in bone mineral density will be compared between groups as an exploratory analysis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 1, 2024
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 18 years or older

• On regular dialysis regimen for at least 3 months

Exclusion Criteria:

• Known allergy to any of the investigational drug components

• Current use of sodium-glucose co-transporter 2 inhibitors

• Pregnant woman

• Myocardial infarction or myocardial revascularization in the past 3 months

Related Conditions & MeSH terms

• End-stage Kidney Disease
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

Drug:
• Dapagliflozin
Dapagliflozin 10mg P.O. daily

Locations

Country	Name	City	State
Brazil	Centro de Pesquisas Clínicas	Campinas	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Campinas, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NT-proBNP	Difference between groups in NT-proBNP change from baseline	6 months
Secondary	Echocardiography	Difference between groups from baseline of the following: ejection fraction, e/e' ratio, global longitudinal and radial strain and indexed left ventricle mass	6 months