DApagliflozin Cardiovascular Effects on Patients at End-stage REnal Disease

NCT ID: NCT05685394

Last Updated: 2023-11-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-24
• Study Completion Date: 2024-12-01

Brief 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.

Conditions

End-stage Kidney Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dapagliflozin

Dapagliflozin 10mg P.O. daily for 6 months add-on to standard treatment

Group Type: EXPERIMENTAL

Dapagliflozin

Intervention Type: DRUG

Dapagliflozin 10mg P.O. daily

Control

No intervention. Patients will be followed for 6 months on their standard treatment.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Dapagliflozin

Dapagliflozin 10mg P.O. daily

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Campinas, Brazil

OTHER

Sponsor Role: lead

Responsible Party

Andrei Carvalho Sposito

Full Professor of Cardiology and Chairman of the Laboratory of Atherosclerosis and Vascular Biology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Centro de Pesquisas Clínicas

Campinas, São Paulo, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Joaquim Barreto, MD

Role: CONTACT

joaquimbarretoantunes@gmail.com

+55 19 3521 7959

Facility Contacts

joaquim b oliveira, md

Role: primary

+55 19 35217959

Other Identifiers

30

Identifier Type: -

Identifier Source: org_study_id