Clinical Trials List
2025-03-01 - 2030-06-30
Recruiting18
ICD-10I50.20
Unspecified systolic (congestive) heart failure
ICD-10I50.21
Acute systolic (congestive) heart failure
ICD-10I50.22
Chronic systolic (congestive) heart failure
ICD-10I50.23
Acute on chronic systolic (congestive) heart failure
ICD-10I50.30
Unspecified diastolic (congestive) heart failure
ICD-10I50.31
Acute diastolic (congestive) heart failure
ICD-10I50.32
Chronic diastolic (congestive) heart failure
ICD-10I50.33
Acute on chronic diastolic (congestive) heart failure
ICD-10I50.40
Unspecified combined systolic (congestive) and diastolic (congestive) heart failure
ICD-10I50.41
Acute combined systolic (congestive) and diastolic (congestive) heart failure
ICD-10I50.42
Chronic combined systolic (congestive) and diastolic (congestive) heart failure
ICD-10I50.43
Acute on chronic combined systolic (congestive) and diastolic (congestive) heart failure
ICD-10I50.9
Heart failure, unspecified
ICD-9428.0
Congestive heart failure
A phase III, randomized, double-blind, placebo-controlled, event-driven trial was conducted to evaluate the effect of Baxdrostat in combination with Dapagliflozin compared to Dapagliflozin alone on the risk of first-time heart failure and cardiovascular death in participants at high risk of developing heart failure.
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Trial Applicant
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Sponsor
AstraZeneca Taiwan Co., Ltd.
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Trial scale
Multi-Regional Multi-Center
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Update
2026/08/10
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 王奇彥 無
- JUN-SING WANG 無
- Cheng-Hung Li 無
- 郭銘荏 無
- Pin-Kuei Fu 無
- 鄭諭聰 無
- 簡育珊 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 洪元 無
- Chien-Yi Hsu 無
- Yung-Ta Kao 無
- 陳志維 無
- 陳彥舟 無
- 鄭宇倫 無
- 蕭卜源 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Tzung-Dau Wang Division of Cardiovascular Diseases
- CHO-KAI WU Division of Cardiovascular Diseases
- JEN-KUANG LEE Division of Cardiovascular Diseases
- 孟士瑋 Division of Cardiovascular Diseases
- 林廷澤 Division of Cardiovascular Diseases
- 林柏志 Division of Cardiovascular Diseases
- MAO-HSIN LIN Division of Cardiovascular Diseases
- HUNG-JU LIN Division of Cardiovascular Diseases
- 柯宗佑 Division of Cardiovascular Diseases
- 洪啟盛 Division of Cardiovascular Diseases
- Hsien Li Kao Division of Cardiovascular Diseases
- 陳俊凱 Division of Cardiovascular Diseases
- 陳盈憲 Division of Cardiovascular Diseases
- 賀立婷 Division of Cardiovascular Diseases
- 黃慶昌 Division of Cardiovascular Diseases
- Chih-Fan Yeh Division of Cardiovascular Diseases
- 鄭人方 Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Kang-Ling Wang 無
- Chern-En Chiang 無
- Wen-Chung Yu 無
- 張俊欽 無
- 張皓智 無
- 曾致學 Division of General Internal Medicine
- 黃偉杰 無
- 黃偉銘 無
- 蔡依霖 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 王宇澄 無
- 林晏年 無
- Shih-Sheng Chang 無
- 陳恬恩 無
- Lien-Cheng Hsiao 無
- 鍾偉信 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 朱志生 Division of Cardiovascular Diseases
- Chun-Yuan Chu Division of Cardiovascular Diseases
- 吳韋璁 Division of Cardiovascular Diseases
- Mei Yueh Lee Division of Endocrinology
- 黃天祈 Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 王晟安 無
- 朱克軒 無
- Jia-Ying Sung Division of Neurology
- 李靜娥 Division of Neurology
- Yung-Kuo Lin 無
- 林辰修 無
- Yi-Chen Lin 無
- Hsing-Yu Weng 無
- 梁浩朋 無
- 莊再庚 無
- 陳右荏 無
- JOWY TANI 無
- 陳春華 無
- Chin-I Chen 無
- 黃仁弘 無
- Chih-Shan Huang 無
- 黃怡臻 無
- 楊弘宇 無
- 廖子崴 無
- Ming-Hsiung Hsieh 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Dapagliflozin
Active Ingredient
BAXDROSTAT
BAXDROSTAT
DAPAGLIFLOZIN
Dosage Form
Film-coated tablets
Dosage
2MG
0.5MG
10MG
Endpoints
• Hospitalization due to HF
• HF without hospitalization
• Death due to CV
Inclution Criteria
Age
1. Participants of any biological and psychological sex must be ≥ 40 years old at the time of signing the participant consent form.
Participant Type and Disease Characteristics
2. Diagnosed with type 2 diabetes requiring treatment (see Appendix F 1)
3. Established cardiovascular disease (ischemic heart disease, cerebrovascular disease, peripheral artery disease) (see Appendix F 1)
4. History of hypertension, with a systolic blood pressure ≥ 130 mmHg at screening and a systolic blood pressure ≥ 120 mmHg at the time of randomization return.
5. At the time of screening return, serum potassium at the central laboratory must meet the following criteria based on the estimated glomerular filtration rate (eGFR) at screening:
o For participants with an estimated glomerular filtration rate (eGFR) ≥ 45 mL/min/1.73 m² at screening, potassium at the time of screening return must be between ≥ 3.0 and ≤ 4.8 mmol/L.
For participants with an estimated glomerular filtration rate (eGFR) < 45 mL/min/1.73 m² at screening, potassium levels must be between ≥ 3.0 and ≤ 4.5 mmol/L at the follow-up screening.
6. At least one additional heart failure risk factor:
o Age ≥ 70 years
o Urine albumin to creatinine ratio (UACR) > 20 mg/g
o Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m²
o History of multivascular disease (at least two: ischemic heart disease, cerebrovascular disease, and peripheral artery disease) (see Appendix F 1)
o History of atrial fibrillation or atrial flutter
o N-terminal pro-B-type natriuretic peptide (NT-proBNP) > 125 ng/L
Sexual Behavior and Contraception/Barrier Method Requirements
7. The method of contraception used should be consistent with the contraceptive methods prescribed to clinical trial participants under local regulations.
Female Participants
8. Non-fertile female participants are defined as those who have undergone permanent sterilization (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy) or are postmenopausal. A participant is considered postmenopausal if they have not menstruated for 12 months prior to their scheduled randomization date and have no other medical cause. The following are age-specific requirements:
(a) Female participants < 50 years of age are considered postmenopausal if they have not menstruated for 12 months or longer after stopping exogenous hormone therapy and their follicle-stimulating hormone (FSH) concentration falls within the postmenopausal range.
(b) Female participants ≥ 50 years of age are considered postmenopausal if they have not menstruated for 12 months or longer after stopping all exogenous hormone therapy.
9. Fertility-promoting female participants must use a highly effective method of contraception. A highly effective method of contraception is defined as one with a failure rate of less than 1% per year when used consistently and correctly. Throughout the entire trial period, and for at least 4 weeks after the last dose of trial treatment, women of childbearing potential who have sexual intercourse with an unsterilized male partner must consent to the use of a highly effective method of contraception, as defined below. Please discuss discontinuation of contraception after this period with your attending physician.
(a) The following are not acceptable methods of contraception: periodic abstinence (natural family planning, sympathobiatic, post-ovulation methods), claims of abstinence during the trial treatment, withdrawal (coitus interruptus), spermicide-only, lactational amenorrhea, female condoms, and male condoms.
(b) Highly effective methods of contraception include: complete abstinence, provided this is acceptable to the participant's usual lifestyle (defined as prohibition of heterosexual intercourse during the overall period of risk associated with the trial treatment); partners who have undergone vasectomy; use of Implanon® (subdermal implant); bilateral tubal ligation; intrauterine contraceptive/levonorgestrel system; home contraceptive injection (Depo-Provera™); ovulation-suppressing oral contraceptives and contraceptive patches (Evra Patch™ and Xulane™); or vaginal contraceptive ring (NuvaRing®).
10. All women of childbearing age must have a negative pregnancy test result at screening and must not be breastfeeding.
Informed Consent
11. The participant must be able to sign a participant consent form, including compliance with the participant consent form and the requirements and limitations set forth in this trial protocol.
12. Before conducting any trial-specific procedures, provide a signed and dated participant consent form (the participant consent form collected during screening).
Exclusion Criteria
1. Pre-existing diagnosis and treatment of heart failure
2. Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m² at screening
3. Known hyperkalemia, defined as potassium ≥ 5.5 mmol/L within the 3 months prior to screening
4. Type 1 diabetes or uncontrolled type 2 diabetes at screening, with glycated hemoglobin (HbA1c) > 10.5% (> 91 mmol/mol)
5. Serum sodium < 135 mmol/L as measured by the central laboratory at screening
6. History of stroke, transient ischemic attack, valve implantation or replacement, carotid artery surgery, carotid angioplasty, or cardiac surgery within the 3 months prior to randomization
7. History of myocardial infarction within the 3 months prior to randomization or within the 1 month prior to randomization (if no further revascularization is planned)
8. History of... 9. Underwent percutaneous coronary intervention within the past 3 months.
10. Known for severe liver dysfunction, defined as Child-Pugh grade C, based on confirmed medical history records.
11. History of adrenal insufficiency (as recorded).
12. Underwent any dialysis (including for acute kidney injury) within the past 3 months.
13. Any acute kidney injury within the past 3 months.
14. Known or known allergy to the trial treatment (e.g., sodium-glucose cotransporter-2 inhibitors (SGLT2i) or active substances or excipients), as determined by the trial administrator.
15. History of organ or bone marrow transplantation, or planned organ transplantation (including kidney transplantation) within 6 months of randomization.
16. Any clinical condition requiring systemic immunosuppressive therapy other than maintenance therapy (maintaining stability for at least 3 months prior to screening).
17. Drug or alcohol abuse deemed unsuitable for participation by the trial administrator.
Previous/combined therapies.
18. Within 4 months prior to screening. 18. Use of any mineralogypsum receptor antagonist (e.g., spironolactone, eplerenone, or finerenone) or aldosterone synthase inhibitor during the week and/or trial period
19. Therapy used in combination with potent cytochrome P450 (CYP) 3A inducers (e.g., apalutamide, avasimibe, carbamazepine, enzalutamide, lumacaftor, mitone, phenytoin, rifampin, rifapentine, St. John's wort)
10. Use of potassium-sparing diuretics (e.g., triamterene or amiloride) and direct renin inhibitors (e.g., aliskiren) at screening
21. Use of potassium-binding agents (e.g., sodium zirconium cyclosilicate, patiromer, or sodium polystyrene) within 4 weeks prior to screening (sulfonate)
Other Exclusion Criteria
21. Any other disease or treatment, as determined by the trial administrator or the commissioning party, that would make the participant unsuitable for participation in this trial, including diseases or treatments that the trial administrator anticipates would prevent the participant from participating throughout the planned trial period (e.g., active malignancy or other diseases that reduce life expectancy to less than 12 months).
22. Participation in another clinical trial using the investigational drug within 3 months prior to randomization.
23. Participation in the planning and/or execution of the trial (applicable to AstraZeneca personnel and/or trial center personnel).
24. For women of childbearing age, a positive pregnancy test result and/or breastfeeding at the time of screening.
The Estimated Number of Participants
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Taiwan
400 participants
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Global
11300 participants
