Clinical Trials List
2017-01-01 - 2020-06-30
Phase III
Terminated13
ICD-10I50
Heart failure
ICD-9428.0
Congestive heart failure
Study to Evaluate the Effect of Dapagliflozin on the Incidence of Worsening Heart Failure or Cardiovascular Death in Patients with Chronic Heart Failure with Reduced Ejection Fraction
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Trial Applicant
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Sponsor
AstraZeneca
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Taiwan National PI
Co-Principal Investigator
- 林幸榮 Division of Cardiovascular Diseases
- Kang-Ling Wang Division of Cardiovascular Diseases
- Shih-Hsien Sung Division of Cardiovascular Diseases
- Wen-Chung Yu Division of Cardiovascular Diseases
- 吳承學 Division of Cardiovascular Diseases
- Tse-Min Lu Division of Cardiovascular Diseases
- Hao-min Cheng Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
10 Terminated
Audit
None
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Lien-Cheng Hsiao Division of Cardiovascular Diseases
- 王宇澄 Division of Cardiovascular Diseases
- 林晏年 Division of Cardiovascular Diseases
- 吳宏彬 Division of Cardiovascular Diseases
- Pei-Ying Pai Division of Cardiovascular Diseases
- Shih-Sheng Chang Division of Cardiovascular Diseases
- 陳恬恩 Division of Cardiovascular Diseases
- 陳科維 Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Zhih-Cherng Chen Division of Cardiovascular Diseases
- 洪俊聲 Division of Cardiovascular Diseases
- Yin-Ching Chuang Division of Cardiovascular Diseases
- 張瑋婷 Division of Cardiovascular Diseases
- 周銘霆 Division of Cardiovascular Diseases
- Chia-Te Liao Division of Cardiovascular Diseases
- 蔣俊彥 Division of Cardiovascular Diseases
- Wei-Ting Chang Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 殷偉賢 Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
Audit
None
Taiwan National PI
The Actual Total Number of Participants Enrolled
6 Terminated
Audit
None
Co-Principal Investigator
Audit
None
Co-Principal Investigator
- CHO-KAI WU Division of Cardiovascular Diseases
- LIAN-YU LIN Division of Cardiovascular Diseases
- Yi-Chih Wang Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Po-Chao Hsu Division of Cardiovascular Diseases
- Chun-Yuan Chu Division of Cardiovascular Diseases
- 顏學偉 Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
Subjects Included in the Composite Endpoint of CV Death, Hospitalization Due to Heart Failure or Urgent Visit Due to Heart Failure. [ Time Frame: Up to 27.8 months. ]
Primary efficacy
Secondary Outcome Measures :
Subjects Included in the Composite Endpoint of CV Death or Hospitalization Due to Heart Failure. [ Time Frame: Up to 27.8 months. ]
Secondary
Events Included in the Composite Endpoint of Recurrent Hospitalizations Due to Heart Failure and CV Death. [ Time Frame: Up to 27.8 months. ]
Secondary
Change From Baseline in the KCCQ Total Symptom Score [ Time Frame: Baseline and 8 months or death before 8 months ]
KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. The KCCQ total symptom score incorporates the symptom domains into a single score. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
Subjects Included in the Composite Endpoint of ≥50% Sustained Decline in eGFR, ESRD or Renal Death. [ Time Frame: Up to 27.8 months. ]
Secondary
Subjects Included in the Endpoint of All-cause Mortality. [ Time Frame: Up to 27.8 months. ]
Secondary
Inclution Criteria
For inclusion in the study patients should fulfil the following criteria:
1. Provision of signed informed consent prior to any study specific procedures
2. Male or female, aged ≥18 years at the time of consent
3. Established documented diagnosis of symptomatic HFrEF (NYHA functional class
II-IV), which has been present for at least 2 months and is optimally treated with
pharmacological and/or device therapy, as indicated
NB: Patients in which additional pharmacological or device therapy is
contemplated, or should be considered, must not be enrolled until therapy has been
optimized and is stable for ≥1 month.
4. LVEF≤40% (echocardiogram, radionuclide ventriculogram, contrast angiography or
cardiac MRI ) within the last 12 months prior to enrolment (Visit 1)
If there is more than one assessment of LVEF the value from the most recent
measurement should be used in assessing eligibility
Patients undergoing coronary revascularization (percutaneous coronary
intervention (PCI) or coronary artery bypass grafting (CABG)), valve
repair/replacement or implantation of a cardiac resynchronization therapy
device (CRT) or any other surgical, device or pharmacological intervention (eg
initiation of a beta-blocker) that might improve LVEF must have a
measurement of LVEF at least 3 months after the intervention in order to be
eligible
NB: Patients with known HFrEF but without a recent (≤12 months) assessment of
LV function will undergo a local echocardiogram at the time of enrolment.
5. NT-proBNP >600 pg/ml (or if hospitalized for heart failure within the previous 12
months, NT-proBNP ≥400 pg/ml) at enrolment (visit 1)
If concomitant atrial fibrillation at Visit 1, NT-proBNP must be ≥900 pg/ml
(irrespective of history of heart failure hospitalization)
6. Patients should receive background standard of care for HFrEF and be treated
according to locally recognized guidelines with both drugs and devices, as
appropriate. Guideline-recommended medications should be used at recommended
doses unless contraindicated or not tolerated. Therapy should have been
individually optimized and stable for ≥4 weeks (this does not apply to diuretics –
see NB below) before visit 1 and include (unless contraindicated or not tolerated):
an ACE inhibitor, or ARB or sacubitril/valsartan
and
a beta-blocker
and
if considered appropriate by the patient’s treating physician; a mineralcorticoid
receptor antagonist (MRA)
NB: Most patients with heart failure require treatment with a diuretic to control
sodium and water retention leading to volume overload. It is recognized that
diuretic dosing may be titrated to symptoms, signs, weight and other information
and may thus vary. Each patient should, however, be treated with a diuretic
regimen aimed at achieving optimal fluid/volume status for that individual.
7. eGFR ≥30 ml/min/1.73 m2 (CKD-EPI formula) at enrolment (visit 1)
Exclusion Criteria
Patients should not enter the study if any of the following exclusion criteria are fulfilled:
1. Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or
previous intolerance of an SGLT2 inhibitor
2. Type 1 diabetes mellitus (T1D)
3. Symptomatic hypotension or systolic BP <95 mmHg on 2 consecutive
measurements
4. Current acute decompensated HF or hospitalization due to decompensated HF <4
weeks prior to enrolment
5. MI, unstable angina, stroke or transient ischemic attack (TIA) within 12 weeks prior
to enrolment
6. Coronary revascularization (percutaneous coronary intervention [PCI] or coronary
artery bypass grafting [CABG]) or valvular repair/replacement within 12 weeks
prior to enrolment or planned to undergo any of these operations after
randomization
7. Implantation of a cardiac CRT within 12 weeks prior to enrolment or intent to
implant a CRT device
8. Previous cardiac transplantation or implantation of a ventricular assistance device
(VAD) or similar device, or implantation expected after randomization
9. HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis,
hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
10. Symptomatic bradycardia or second or third degree heart block without a
pacemaker
11. Any condition outside the CV and renal disease area, such as but not limited to
malignancy, with a life expectancy of less than 2 years based on investigator´s
clinical judgement
12. Active malignancy requiring treatment at the time of visit 1(with the exception of
successfully treated basal cell or treated squamous cell carcinoma)
13. Hepatic impairment aspartate transaminase [AST] or alanine transaminase [ALT]
>3x the upper limit of normal [ULN]; or total bilirubin >2x ULN at time of
enrolment)
14. Known blood-borne diseases such as specified in Appendix B (category A and B)
15. Severe (eGFR <30 mL/min/1.73 m2 by CKD-EPI), unstable or rapidly progressing
renal disease at the time of randomization
16. Women of child-bearing potential (ie, those who are not chemically or surgically
sterilised or who are not post-menopausal) who are not willing to use a medically
accepted method of contraception that is considered reliable in the judgment of the
investigator OR women who have a positive pregnancy test at enrolment or
randomization OR women who are breast-feeding
17. Involvement in the planning and/or conduct of the study (applies to both
AstraZeneca personnel and/or personnel at the study site)
18. Previous randomization in the present study
19. Participation in another clinical study with an IP during the last month prior to
enrolment
20. Inability of the patient, in the opinion of the investigator, to understand and/or
comply with study medications, procedures and/or follow-up OR any conditions
that, in the opinion of the investigator, may render the patient unable to complete
the study
NB: Patients who cannot complete the ePRO assessments can still participate in the
study (see Section 5.1.11.5 for details regarding the patient exclusion from the ePRO
assessments during certain circumstances)
Procedures for withdrawal of incorrectly enrolled patients see Section 3.4.
The Estimated Number of Participants
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Taiwan
141 participants
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Global
4744 participants
