DApagliflozin Cardiovascular Effects on Patients at End-stage REnal Disease

NCT05685394 | Unknown Phase 4

• 1 other identifier: 30
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• NT-proBNP

  Difference between groups in NT-proBNP change from baseline

  6 months

Secondary Outcomes (1)

• Echocardiography

  6 months

Study Arms (2)

Dapagliflozin

EXPERIMENTAL

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

Drug: Dapagliflozin

Control

NO INTERVENTION

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

Interventions

Dapagliflozin DRUG

Dapagliflozin 10mg P.O. daily

Dapagliflozin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• On regular dialysis regimen for at least 3 months

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Campinas, Brazil: lead

Study Sites (1)

Centro de Pesquisas Clínicas

Campinas, São Paulo, 13083610, Brazil

RECRUITING

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Joaquim Barreto, MD

CONTACT

+55 19 3521 7959; joaquimbarretoantunes@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor of Cardiology and Chairman of the Laboratory of Atherosclerosis and Vascular Biology

Model Details: Prospective, randomized, open-label, controlled trial

Study Record Dates

• First Submitted: January 5, 2023
• First Posted: January 17, 2023
• Study Start: January 24, 2023
• Primary Completion: November 1, 2024
• Study Completion: December 1, 2024
• Last Updated: November 14, 2023

Record last verified: 2023-11

Locations

BR (1)