Clinical Trials List
2018-11-19 - 2022-12-01
Phase III
Recruiting13
ICD-10I50
Heart failure
An International, Double-blind, Randomised, Placebo-Controlled Phase III Study to Evaluate the Effect of Dapagliflozin on Reducing CV Death or Worsening Heart Failure in Patients With Heart Failure With Preserved Ejection Fraction (HFpEF)
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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
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 林晏年 Division of Cardiovascular Diseases
- 陳恬恩 Division of Cardiovascular Diseases
- 王宇澄 Division of Cardiovascular Diseases
- Shih-Sheng Chang Division of Cardiovascular Diseases
- Lien-Cheng Hsiao Division of Cardiovascular Diseases
- 陳科維 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
- 董穎璋 Division of Cardiovascular Diseases
- 詹益欣 Division of Cardiovascular Diseases
- 王俊力 Division of Cardiovascular Diseases
- Wan-Jing Ho Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 王奇彥 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
- 林志展 Division of Cardiovascular Diseases
- 黃成偉 Division of Cardiovascular Diseases
- 謝棟漢 Division of Cardiovascular Diseases
- Cheng-Han Lee Division of Cardiovascular Diseases
- Ju-Yi Chen Division of Cardiovascular Diseases
- Wei-Chuan Tsai Division of Cardiovascular Diseases
- Chih-Hsin Hsu Division of Cardiovascular Diseases
- Shih-Hung Chan Division of Cardiovascular Diseases
- Po-Tseng Lee Division of Cardiovascular Diseases
- 李文煌 Division of Cardiovascular Diseases
- 陳柏偉 Division of Cardiovascular Diseases
- Yen-Wen Liu Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Recruiting
Audit
None
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
Audit
None
Co-Principal Investigator
Audit
None
Co-Principal Investigator
- HUNG-JU LIN Division of General Internal Medicine
- - - Division of General Internal Medicine
- YEN-HUNG LIN Division of General Internal Medicine
- 林柏志 Division of General Internal Medicine
- 洪啟盛 Division of General Internal Medicine
- 張恬君 Division of General Internal Medicine
- 黃惠君 Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Audit
None
Co-Principal Investigator
- Yung-Ta Kao Division of Cardiovascular Diseases
- Tsung-Lin Yang Division of Cardiovascular Diseases
- Chien-Yi Hsu Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Hsiang Chun Lee Division of Cardiovascular Diseases
- Chun-Yuan Chu Division of Cardiovascular Diseases
- WEN-TER Lai Division of Cardiovascular Diseases
- 吳韋璁 Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Recruiting
Taiwan National PI
Co-Principal Investigator
- Kang-Ling Wang Division of Cardiovascular Diseases
- Wen-Chung Yu Division of Cardiovascular Diseases
- 黃少嵩 Division of Cardiovascular Diseases
- Hao-min Cheng Division of Cardiovascular Diseases
- Shih-Hsien Sung Division of Cardiovascular Diseases
- Tse-Min Lu Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
40 Recruiting
Audit
None
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
Time to the first occurrence of any of the components of this composite: 1) CV death; 2) Hospitalisation for HF; 3) Urgent HF visit (e.g., emergency department or outpatient visit) [ Time Frame: Up to approximately 39 months ]
To determine whether dapagliflozin is superior to placebo, when added to standard of care, in reducing the composite of CV death and HF events (hospitalisation for HF or urgent HF visit) in patients with HF and preserved systolic function in
full study population
subpopulation with LVEF <60%
Secondary Outcome Measures :
Total number of HF events (first and recurrent) and CV death [ Time Frame: up to approximately 39 months ]
To determine whether dapagliflozin is superior to placebo in reducing the total number of HF events (hospitalisation for HF or urgent HF visit) and CV death in
full study population
subpopulation with LVEF <60%
Change from baseline in the total symptom score (TSS) of the KCCQ at 8 months [ Time Frame: Evaluated at 8 months after randomization ]
To determine whether dapagliflozin is superior to placebo in improving Patient Reported Outcomes measured by KCCQ
Time to the occurrence of CV death [ Time Frame: up to approximately 39 months ]
To determine whether dapagliflozin is superior to placebo in reducing CV death
Time to the occurrence of death from any cause [ Time Frame: up to approximately 39 months ]
To determine whether dapagliflozin is superior to placebo in reducing all-cause mortality
Inclution Criteria
Subjects are eligible to be randomised in the study only if all of the following inclusion criteria
and none of the exclusion criteria apply:
1. Provision of signed informed consent prior to any study specific procedures.
2. Male or female patients age ≥40 years.
3. Documented diagnosis of symptomatic heart failure (NYHA class II-IV) at enrolment, and a medical history of typical symptoms/signs2 of heart failure ≥6 weeks before enrolment with at least intermittent need for diuretic treatment.
4. Left Ventricular Ejection Fraction (LVEF) >40% and evidence of structural heart disease (i.e. left ventricular hypertrophy or left atrial enlargement3 ) documented by the most recent echocardiogram, and/or cardiac MR within the last 12 months prior to
enrolment. For patients with prior acute cardiac events or procedures that may reduce LVEF, e.g. as defined in exclusion criterion 6, qualifying cardiac imaging assessment at least 12 weeks following the procedure/event is required.
5. NT-pro BNP ≥300 pg/ml at Visit 1 for patients without ongoing atrial fibrillation/flutter. If ongoing atrial fibrillation/flutter at Visit 1, NT-pro BNP must be ≥600 pg/mL.
6. Patients may be ambulatory, or hospitalized; patients must be off intravenous heart failure therapy (including diuretics) for at least 12 hours prior to enrolment and 24 hours prior to randomisation.
Exclusion Criteria
1. Receiving therapy with an SGLT2 inhibitor within 4 weeks prior to randomisation or previous intolerance to an SGLT2 inhibitor
2. Type 1 diabetes mellitus (T1D)
3. eGFR <25 mL/min/1.73 m2 (CKD-EPI formula) at Visit 1
4. Systolic blood pressure (BP) <95 mmHg on 2 consecutive measurements at 5-minute intervals, at Visit 1 or at Visit 2
5. Systolic BP≥160 mmHg if not on treatment with ≥3 blood pressure lowering medications
or ≥180 mmHg irrespective of treatments, on 2 consecutive measurements at 5-minute intervals, at Visit 1 or at Visit 2.
6. MI, unstable angina, coronary revascularization (percutaneous coronary intervention (PCI)
or coronary artery bypass grafting (CABG)), ablation of atrial flutter/fibrillation, valve
repair/replacement within 12 weeks prior to enrolment. Before enrolment, these patients
must have their qualifying echocardiography and/or cardiac MRI examination at least 12 weeks after the event.
7. Planned coronary revascularization, ablation of atrial flutter/fibrillation and valve repair/replacement.
8. Stroke or transient ischemic attack (TIA) within 12 weeks prior to enrolment
9. Probable alternative or concomitant diagnoses which in the opinion of the investigator
could account for the patient's HF symptoms and signs (e.g. anaemia, hypothyroidism)
10. Body mass index >50 kg/m2
11. Primary pulmonary hypertension, chronic pulmonary embolism, severe pulmonary disease
including COPD (i.e., requiring home oxygen, chronic nebulizer therapy or chronic oral
steroid therapy, or hospitalisation for exacerbation of COPD requiring ventilatory assist
within 12 months prior to enrolment)
12. Previous cardiac transplantation, or complex congenital heart disease. Planned cardiac
resynchronisation therapy.
13. HF due to any of the following: known infiltrative cardiomyopathy (e.g. amyloid, sarcoid,
lymphoma, endomyocardial fibrosis), active myocarditis, constrictive pericarditis, cardiac
tamponade, known genetic hypertrophic cardiomyopathy or obstructive hypertrophic
cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy/dysplasia (ARVC/D),
or uncorrected primary valvular disease
14. A life expectancy of less than 2 years due to any non-cardiovascular condition, based on
investigator's clinical judgement.
15. 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
16. Active malignancy requiring treatment (with the exception of basal cell or squamous cell
carcinomas of the skin).
17. Acute or chronic liver disease with severe impairment of liver function (e.g., ascites,
oesophageal varices, coagulopathy)
18. Women of child-bearing potential (i.e. those who are not chemically or surgically sterilised
or post-menopausal) not willing to use a medically accepted method of contraception
considered reliable in the judgment of the investigator OR who have a positive pregnancy
test at randomisation OR who are breast-feeding
19. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca
personnel and/or personnel at the study site)
20. Previous randomisation in the present study
21. Participation in another clinical study with an IP or device during the last month prior to enrolment
The Estimated Number of Participants
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Taiwan
300 participants
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Global
4700 participants
