Heart Failure With Reduced Ejection FractionPhase 4NCT05737186
SGLT2 Inhibitors and Treatment of Heart Failure in Severe Renal Insufficiency
A Phase 4 study testing SGLT-2 inhibitor in people with Heart Failure With Reduced Ejection Fraction and Renal Insufficiency, Chronic, run by Peking University People's Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Heart Failure With Reduced Ejection Fraction, Renal Insufficiency, Chronic
- What is being tested?
- SGLT-2 inhibitor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteChina
- Study dates
- 9 Mar 2023to 16 Apr 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
- Being tested
- SGLT-2 inhibitor
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SGLT-2 inhibitorDrug
dapagliflozin
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Not described Receives: Drug: SGLT-2 inhibitor |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The quality of Life
The change of Quality of Life in patients by using the The Kansas City Cardiomyopathy Questionnaire(KCCQ)
Measured: 12 weeks
Secondary outcomes (5)
The quality of Life
The change of Quality of Life in patients by using the KCCQ
Measured: 2 weeks, 4weeks and 8weeks
Dose changes of diuretics
Dose changes of diuretics in subgroups of patients without dialysis
Measured: 12 weeks
Changes of eGFR
Changes of eGFR in the subgroup of non-dialysis patients at 2 and 12 weeks
Measured: 2 and 12 weeks
Changes of brain natriuretic peptide (BNP)
Changes of BNP
Measured: 12 weeks
Changes of body weight
Changes of Body weight and BMI
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start9 Mar 2023
- Primary completion16 Apr 2024
- Study completion16 Apr 2024
Why it stopped: Double blind packaged drug is up to expiration date
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Reduced Ejection FractionStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ren qian, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05737186
- Sponsor's protocol ID
- DAPA-FF
- Status last verified
- Apr 2024
- First submitted
- 12 Feb 2023
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05737186
- Acronym / sponsor ID
- DAPA-FF
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Double blind packaged drug is up to expiration date
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 9 Mar 2023 (actual)
- Primary completion
- 16 Apr 2024 (actual)
- Study completion
- 16 Apr 2024 (actual)
- First posted
- 21 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Drug: SGLT-2 inhibitor |
| Control group | No intervention | – |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SGLT-2 inhibitordapagliflozin | Drug | Intervention group |
Primary outcome
The quality of Life
Time frame: 12 weeks
The change of Quality of Life in patients by using the The Kansas City Cardiomyopathy Questionnaire(KCCQ)
5 secondary outcomes
The quality of Life
Time frame: 2 weeks, 4weeks and 8weeks
Dose changes of diuretics
Time frame: 12 weeks
Changes of eGFR
Time frame: 2 and 12 weeks
Changes of brain natriuretic peptide (BNP)
Time frame: 12 weeks
Changes of body weight
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: Double blind packaged drug is up to expiration date). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing SGLT-2 inhibitor in people with Heart Failure With Reduced Ejection Fraction and Renal Insufficiency, Chronic, run by Peking University People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Double blind packaged drug is up to expiration date). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The quality of Life (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2024.