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SGLT2 Inhibitors and Treatment of Heart Failure in Severe Renal Insufficiency

Primary Purpose

Heart Failure With Reduced Ejection Fraction, Renal Insufficiency, Chronic

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
SGLT-2 inhibitor
Sponsored by
Peking University People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure With Reduced Ejection Fraction

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age 20-75 years Patients with clinically confirmed chronic heart failure who have received treatment for heart failure according to the guidelines in the past two months, New York Heart Association (NYHA) grade II-IV Left ventricular ejection fraction (LVEF) ≤ 40% in the past 1 year Clinically confirmed chronic renal insufficiency, eGFR<20ml/min/1.73m2 or maintenance hemodialysis Exclusion Criteria: Allergy to SGLT-2i ALT or AST >3 times the upper limit of normal value; Or total bilirubin>2 times the upper limit of normal value Urinary or reproductive system infection in the last month Blood potassium is greater than or equal to the upper limit of normal value Patients with acute heart failure Patients who need intravenous diuretics before randomization, and the dose is greater than 40mg furosemide, or other equivalent intravenous loop diuretics Patients who need intravenous vasodilators, including nitrates, before randomization Systolic blood pressure<100mmHg measured during screening or at randomization Hemoglobin<90g/L Uncontrolled serious arrhythmia Myocardial infarction, unstable angina pectoris, hemorrhagic stroke or ischemic stroke in 90 days before randomization Proliferative retinopathy or macular disease, painful diabetes neuropathy, diabetes foot, diabetes ketoacidosis, hyperglycemic hyperosmolality that needed treatment in 90 days before randomization Patients with malignant tumors Drug or alcohol addicts Patients who have donated or transfused blood within 90 days before randomization, or are expected to donate or transfuse blood during the study period Pregnant or lactating women, or patients who cannot take reliable contraceptive measures during the study period Patients with uncontrolled abnormal thyroid function Type 1 diabetes Not suitable evaluated by the investigator

Sites / Locations

  • Peking University People's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

Outcomes

Primary Outcome Measures

The quality of Life
The change of Quality of Life in patients by using the The Kansas City Cardiomyopathy Questionnaire(KCCQ)

Secondary Outcome Measures

The quality of Life
The change of Quality of Life in patients by using the KCCQ
Dose changes of diuretics
Dose changes of diuretics in subgroups of patients without dialysis
Changes of eGFR
Changes of eGFR in the subgroup of non-dialysis patients at 2 and 12 weeks
Changes of brain natriuretic peptide (BNP)
Changes of BNP
Changes of body weight
Changes of Body weight and BMI

Full Information

First Posted
February 12, 2023
Last Updated
March 28, 2023
Sponsor
Peking University People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05737186
Brief Title
SGLT2 Inhibitors and Treatment of Heart Failure in Severe Renal Insufficiency
Official Title
The Efficacy and Safety of SGLT2 Inhibitors in Improving Heart Failure in Patients With Chronic Heart Failure With Reduced Ejection Fraction (HFrEF) and Severe Renal Insufficiency
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 9, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
In the treatment of heart failure (HF), SGLT-2 inhibitor (SGLT-2i) can significantly improve the clinical outcome and quality of life related to HF. The current data show that SGLT-2i is effective and safe in improving HF outcomes in patients with chronic kidney disease (CKD) stage 4, but there is little clinical evidence in patients with eGFR<20 ml/min/1.73 m2. Therefore, our research is designed to confirm that SGLT-2i can improve the outcome of HF in patients with chronic heart failure with reduced ejection fraction (HFrEF) and severe chronic renal insufficiency (eGFR<20ml/min/1.73m2).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure With Reduced Ejection Fraction, Renal Insufficiency, Chronic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Title
Control group
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
SGLT-2 inhibitor
Intervention Description
dapagliflozin
Primary Outcome Measure Information:
Title
The quality of Life
Description
The change of Quality of Life in patients by using the The Kansas City Cardiomyopathy Questionnaire(KCCQ)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
The quality of Life
Description
The change of Quality of Life in patients by using the KCCQ
Time Frame
2 weeks, 4weeks and 8weeks
Title
Dose changes of diuretics
Description
Dose changes of diuretics in subgroups of patients without dialysis
Time Frame
12 weeks
Title
Changes of eGFR
Description
Changes of eGFR in the subgroup of non-dialysis patients at 2 and 12 weeks
Time Frame
2 and 12 weeks
Title
Changes of brain natriuretic peptide (BNP)
Description
Changes of BNP
Time Frame
12 weeks
Title
Changes of body weight
Description
Changes of Body weight and BMI
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 20-75 years Patients with clinically confirmed chronic heart failure who have received treatment for heart failure according to the guidelines in the past two months, New York Heart Association (NYHA) grade II-IV Left ventricular ejection fraction (LVEF) ≤ 40% in the past 1 year Clinically confirmed chronic renal insufficiency, eGFR<20ml/min/1.73m2 or maintenance hemodialysis Exclusion Criteria: Allergy to SGLT-2i ALT or AST >3 times the upper limit of normal value; Or total bilirubin>2 times the upper limit of normal value Urinary or reproductive system infection in the last month Blood potassium is greater than or equal to the upper limit of normal value Patients with acute heart failure Patients who need intravenous diuretics before randomization, and the dose is greater than 40mg furosemide, or other equivalent intravenous loop diuretics Patients who need intravenous vasodilators, including nitrates, before randomization Systolic blood pressure<100mmHg measured during screening or at randomization Hemoglobin<90g/L Uncontrolled serious arrhythmia Myocardial infarction, unstable angina pectoris, hemorrhagic stroke or ischemic stroke in 90 days before randomization Proliferative retinopathy or macular disease, painful diabetes neuropathy, diabetes foot, diabetes ketoacidosis, hyperglycemic hyperosmolality that needed treatment in 90 days before randomization Patients with malignant tumors Drug or alcohol addicts Patients who have donated or transfused blood within 90 days before randomization, or are expected to donate or transfuse blood during the study period Pregnant or lactating women, or patients who cannot take reliable contraceptive measures during the study period Patients with uncontrolled abnormal thyroid function Type 1 diabetes Not suitable evaluated by the investigator
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qian Ren, M.D.
Phone
00861088324102
Email
qianqianren@outlook.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xiangqing Wang, M.D.
Phone
00861088324100
Facility Information:
Facility Name
Peking University People's Hospital
City
Beijing
State/Province
Please Select
ZIP/Postal Code
100044
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qian Ren, M.D.
Phone
00861088324102
Email
qianqianren@outlook.com
First Name & Middle Initial & Last Name & Degree
Xiangqing Wang, M.D.
Phone
00861088324100

12. IPD Sharing Statement

Learn more about this trial

SGLT2 Inhibitors and Treatment of Heart Failure in Severe Renal Insufficiency

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