The Safety of Dapagliflozin in Hemodialysis Patients With Heart Failure (SDHF)

May 7, 2022 updated by: Leyi Gu, RenJi Hospital

SGLT2 inhibitor is a new type of sugar-lowering medicine and is recommended to treat heart failure. eGFR lower than 30ml/min/1.73M2 is contraindication of SGLT2 inhibitor. Heart failure is one of the most frequency CVD events for hemodialysis patients. But hemodialysis patient is unable to be treated with SGLT2 inhibitors as the contraindication. However, solute and fluid clearance are dependent on dialysis, but not renal function in hemodialysis patients. There is no data of SGLT2 inhibitor on hemodialysis patients. The aim of the present study is evaluate the safety of Dapagliflozin in hemodialysis patients with heart failure.

This is a randomized, control, open study. 20 hemodialysis patients with heart failure will be recruited. 10 of 20 subjects will be treated with dapagliflozin 10mg everyday for 12 weeks. The primary outcome is the number of patients with hypoglycemia or urinary infection. The secondary outcomes is the changes of NT-.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Evaluate the safety of dapagliflozin in hemodialysis patients with heart failure is the main purpose of this study. and Estimate the change of NT-proBNP is the secondary purpose.

This is a randomized, control and open study.

The including criteria are 1. Understand the present study and sign informed consert 2. Age is between 18 and 70 3. 2 or 3 times blood purification treatments (inclusion hemodialysis, hemofiltration, hemoperfusion) every week, 4. Blood purification treatment more than 3 month 5. Using AV fistula or artificial vascular access 6. With chronic heart failure (NYHC II-IV), and NT-proBNP>11500 or BNP>500 7. ARNI or RAS inhibitor or Aldosterone inhibitors treatment for at least 4 weeks with a stable dose The exclusion criteria are 1.Blood purification less than 3 month 2.With fluid overload and URR<50% 3.Have severe hypoglycemia (more than 2 events with 4 weeks prior to sign concert information) 4.Have severe hypotension (blood pressure <90/60mmHg more than 3 times with 4 weeks prior to sign concert information) 5.Have acute pulmonary edema 6.Have ketoacidosis 7.Have active pyelnephritis and symptomatic lower urinary infection 8.Subject is pregnant , is breast feeding 9.Subject has known SGLT2 inhibitor allergy or intolerance adverse reactions 10.Subject is currentluy enrolled in or has not yet completed at least 30days since ending other investigational device or drug trials 11.Investigator believe subject is not suitable for this study

Subjects will divide into two groups. Dapa group will be treated with dapagliflozin 10mg qd and standard anti-heart failure therapy. Control group will be treated with standard anti-heart failure therapy.

The primary outcome is the number of patients with hypoglycemia or urinary tract infection. The secondary outcome is the change of NT-proBNP

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200127
        • Recruiting
        • Department of nephrology , Renji Hospital, Shanghai Jiao Tong University School of Medicine
        • Contact:
        • Principal Investigator:
          • Leyi Gu, Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Understand the present studyAgree and sign informed consert
  2. Age is between 18 and 70 Men or women ≧18 years and <70 years of age at screening
  3. Treated with maintenance blood purification 2 or 3 times blood purification treatments (including hemodialysis, hemofiltration, hemoperfusion) every week2 or 3 times a week,
  4. Blood purification treatment more than 3 month before randomization
  5. Blood purification by uUsing AV fistula or artificial vascular access
  6. DiagnosisWith chronic heart failure (NYHC II-IV), and NT-proBNP>11500 or BNP>500
  7. ARNI or RAS inhibitor or Aldosterone inhibitors or beta receptor blocker treatment for at least 4 weeks with a stable dose.

Exclusion Criteria:

  1. Blood purification less than 3 month
  2. With fluid overload and URR<50%
  3. Have severe hypoglycemia (more than 2 events with 4 weeks prior to sign concert information)
  4. Have severe hypotension (blood pressure <90/60mmHg more than 3 times with 4 weeks prior to sign concert information)
  5. Have acute pulmonary edema
  6. Have ketoacidosis
  7. Have active pyelnephritis and symptomatic lower urinary infection
  8. Subject is pregnant , is breast feeding
  9. Subject has known SGLT2 inhibitor allergy or intolerance adverse reactions
  10. Subject is currentluy enrolled in or has not yet completed at least 30days since ending other investigational device or drug trials
  11. Investigator believe subject is not suitable for this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: dapa group
subjects will be treated with dapagliflozin (10mg per day) and standard anti-heart failure therapy (including RAS inhibitors, beta-blocker, Aldosterone inhibitors)
Drug: Dapagliflozin 10Mg Tab
In both group, subjects keep blood purification and anti heart failure treatment, including ARNI, RASi, Aldosterone inhibitors and beta receptor blocker.
Other Names:
  • Control
No Intervention: control group
subjects will be treated with standard anti-heart failure therapy (including RAS inhibitors, beta-blocker, Aldosterone inhibitors)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the number of patients with hypoglycemia or urinary tract infection
Time Frame: 12 weeks
the number of patients with hypoglycemia or urinary tract infection
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of NT-proBNP
Time Frame: 12 weeks
Change of NT-proBNP
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RenJi Hospital

Investigators

  • Principal Investigator: Leyi Gu, RenJi Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 3, 2022

Primary Completion (Anticipated)

July 31, 2022

Study Completion (Anticipated)

July 31, 2022

Study Registration Dates

First Submitted

November 7, 2021

First Submitted That Met QC Criteria

November 20, 2021

First Posted (Actual)

December 2, 2021

Study Record Updates

Last Update Posted (Actual)

May 10, 2022

Last Update Submitted That Met QC Criteria

May 7, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY2021-162

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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