Clinical Trials List
2024-03-01 - 2027-12-31
Phase III
Not yet recruiting11
Recruiting10
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, Randomised, Double-blind Study to Evaluate the Effect of Balcinrenone/Dapagliflozin, Compared with Dapagliflozin, on the Risk of Heart Failure Events and Cardiovascular Death in Patients with Heart Failure and Impaired Kidney Function
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Trial Applicant
-
Sponsor
AZ
-
Trial scale
Multi-Regional Multi-Center
-
Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- 黃天祈 無
- 吳韋璁 無
- 朱志生 無
- Ye-Hsu Lu 無
- 洪啟智 無
- Chun-Yuan Chu 無
- Po-Chao Hsu 無
- Shang-Jyh Hwang 無
- Wei-Chung Tsai 無
- 卓士傑 無
- Yi wen chiu 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- JEN-KUANG LEE 無
- 洪啟盛 無
- Chih-Fan Yeh 無
- 江君揚 無
- VIN-CENT Wu 無
- 林柏志 無
- 賀立婷 無
- - - 無
- CHO-KAI WU 無
- HUNG-JU LIN 無
- 黃道民 無
- CHUN-FU LAI 無
- Tzung-Dau Wang 無
- Hsien Li Kao 無
- 蔡承烜 無
The Actual Total Number of Participants Enrolled
0 Not yet 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 Not yet recruiting
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- Chern-En Chiang 無
- 李慶威 無
- 黃偉銘 無
- Hao-min Cheng 無
- 吳承學 無
- 郭泠 無
- Tze-Fan Chao 無
- Kang-Ling Wang 無
- 黃少嵩 無
- 蔡依霖 無
- Wen-Chung Yu 無
- 張俊欽 無
- 廖若男 無
- Tse-Min Lu 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 Not yet recruiting
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- 蔣俊彥 無
- 洪俊聲 無
- Chia-Te Liao 無
- 施志遠 無
- 黃聖中 無
- 李威杰 無
- Zhih-Cherng Chen 無
- 黃沛頡 無
- 林志憲 無
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- 陳右荏 無
- 林辰修 無
- 莊再庚 無
- 朱克軒 無
- Yung-Kuo Lin 無
- Ming-Hsiung Hsieh 無
- 王晟安 無
- 黃仁弘 無
- 楊弘宇 無
The Actual Total Number of Participants Enrolled
0 Not yet 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
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
DAPAGLIFLOZIN
Dosage Form
116
Dosage
10 mg
Endpoints
the composite of:
• CV death
• HF hospitalisation
• HF event without hospitalisation
Inclution Criteria
1 Participant must be ≥ 18 years old, at the time of signing the informed consent.
Type of Participant and Disease Characteristics
2 Documented diagnosis of symptomatic HF (NYHA functional Class II to IV), present
before the last event.
3 Having had a recent HF event†, defined as either:
a. A hospitalisation primarily for a HF indication including signs and symptoms
of congestions and use of parenteral medications for HF during admission
within 6 months prior to randomisation, OR
b. An urgent HF visit with outpatient parenteral medications for HF within 6
months prior to randomisation, OR
c. Currently hospitalised due to worsening of chronic HF, but with none of the
following within the last 24 hours of randomisation:
i. Invasive or non-invasive ventilation
ii. IV vasopressor, IV vasodilator use including nitrates or IV inotropes
iii. Increase in dose of IV diuretics
4 Have a LVEF value from an assessment within the last 12 months. Participants not
assessed within that timeframe may undergo a local echocardiogram at the time of
enrolment.
a. Participant who have undergone coronary revascularisation (percutaneous
coronary intervention or coronary artery bypass grafting), valve
repair/replacement or implantation of a cardiac resynchronisation therapy
device or any other surgical, device that might improve LVEF must have had a
measurement of LVEF at least 3 months after the intervention in order to be
eligible.
5 Managed with SoC therapy for HF and impairmed kidney function according to local
guidelines (with the exception of MRA), with or without SGLT2 inhibitors.
a. SGLT2 inhibitors can be taken up to the day before randomisation (ie, start of
double-blind treatment). Participants on SGLT2i prior to randomisation will
switch to blinded study therapy at randomisation and will discontinue the
SGLT2i they were prescribed before the randomisation.
6 Not taking an MRA, for one of the following reasons:
a. Mineralocorticoid receptor antagonist not indicated due to LVEF of > 40%
(HFmrEF and HFpEF)
b. Mineralocorticoid receptor antagonist not recommended or contraindicated due
to low eGFR (as per local guidelines)
c. History of MRA adverse reaction/intolerance from approved MRA;
Hyperkalaemia, Worsening kidney function, Hypotension, Hormonal side
effects (such as gynecomastia, erectile dysfunction)
d. Specific concerns for adverse reactions from approved MRAs; hyperkalaemia,
worsening kidney function, hypotension, hormonal side effects (such as
gynecomastia, erectile dysfunction)
7 An eGFR ≥ 20 to < 60 mL/min/1.73 m2, from Visit 1*.
8 Serum or plasma potassium ≥ 3.5 mmol/L and ≤ 5.0 mmol/L at Visit 1.
9 NT-proBNP must be > 300 pg/mL at Visit 1 (> 600 pg/mL if concomitant atrial
fibrillation or atrial flutter at Visit 1). If available, a local laboratory result (serum or
plasma) from < 30 days prior to Visit 1 can be used for inclusion. For participants
randomised while hospitalised, any local value must have been collected during the
index event.
a. For participants randomised while hospitalised and where NT-proBNP is not
available in local laboratory results used to determine eligibility, BNP result
(serum or plasma) must be > 100 pg/mL if sinus rhythm (> 300 pg/mL if
concomitant atrial fibrillation at Visit 1).
Exclusion Criteria
Cardiac and vascular conditions
1 Systolic BP < 100 mmHg, or symptomatic hypotension within the past 24 hours, at
randomisation.
2 Systolic BP ≥ 160 mmHg if on treatment with < 3 blood pressure lowering
medications or ≥ 180 mmHg irrespective of treatments, at enrolment or
randomisation.
3 Acute coronary syndrome (unstable angina or myocardial infarction), stroke or
transient ischaemic attack within the previous 3 months.
4 Major cardiac surgery, coronary revascularisation or valvular repair or replacement, or
implantation of a Cardiac resynchronisation therapy device within 3 months prior to
enrolment or planned to undergo any of these operations after randomisation
5 History of the following cardiomyopathies: hypertrophic obstructive, infiltrative (such
as but not limited to diagnosed amyloidosis), restrictive, genetic or familial,
arrhythmogenic right ventricular cardiomyopathy; Chaga’s cardiomyopathy is
permitted
6 Active myocarditis or pericardial causes of HF (eg, constriction or tamponade)
7 Complex congenital heart disease or severe uncorrected primary valvular disease
8 Symptomatic bradycardia or second- or third-degree heart block without a pacemaker
9 History of mechanical circulatory support (such as left ventricular assist device), heart
transplant or on heart transplant list)
10 Probable alternative or concomitant diagnoses which could account for the
participant’s HF symptoms and signs (eg, severe anaemia, hypothyroidism, nephrotic
syndrome)
11 Primary pulmonary hypertension, chronic pulmonary embolism, severe pulmonary
disease including COPD (eg, requiring home oxygen or frequent hospitalisation) or
exacerbation of COPD requiring invasive mechanical ventilation assistance within
12 months prior to enrolment)
The Estimated Number of Participants
-
Taiwan
242 participants
-
Global
4800 participants
