Dare-Esrd: DApagliflozin Cardiovascular Effects on Patients at End-stage REnal Disease

Sponsor

University of Campinas, Brazil (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05685394

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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 will include mean change in ejection fraction, e/e' ratio, global longitudinal and radial strain and indexed left ventricle mass.

Condition or Disease	Intervention/Treatment	Phase
End-stage Kidney Disease	Drug: Dapagliflozin	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Prospective, randomized, open-label, controlled trialProspective, randomized, open-label, controlled trial

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Dapagliflozin Cardiovascular Effects on Patients at End-stage Renal Disease

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Nov 1, 2023

Anticipated Study Completion Date :

Feb 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dapagliflozin Dapagliflozin 10mg P.O. daily for 6 months add-on to standard treatment	Drug: Dapagliflozin Dapagliflozin 10mg P.O. daily
No Intervention: Control No intervention. Patients will be followed for 6 months on their standard treatment.

Arm

Intervention/Treatment

Experimental: Dapagliflozin

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

Drug: Dapagliflozin

Dapagliflozin 10mg P.O. daily

No Intervention: Control

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

Outcome Measures

Primary Outcome Measures

NT-proBNP [6 months]
Difference between groups in NT-proBNP change from baseline

Secondary Outcome Measures

Echocardiography [6 months]
Difference between groups from baseline of the following: ejection fraction, e/e' ratio, global longitudinal and radial strain and indexed left ventricle mass

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Campinas, Brazil

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Andrei Carvalho Sposito, Full Professor of Cardiology and Chairman of the Laboratory of Atherosclerosis and Vascular Biology, University of Campinas, Brazil

ClinicalTrials.gov Identifier:

NCT05685394

Other Study ID Numbers:

First Posted:

Jan 17, 2023

Last Update Posted:

Jan 17, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Kidney Diseases

Kidney Failure, Chronic

Dapagliflozin

Study Results

No Results Posted as of Jan 17, 2023