Clinical Trials List
2021-05-01 - 2024-09-19
Phase II/III
Not yet recruiting1
Recruiting11
Terminated1
Study ended1
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 Randomised, Double-blind, Placebo-controlled, Multi-center Sequential Phase 2b and Phase 3 Study to Evaluate the Efficacy and Safety of AZD4831 Administered for Up to 48 Weeks in Participants with Heart Failure with Left Ventricular Ejection Fraction > 40%
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Trial Applicant
-
Sponsor
AstraZeneca
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- WEN-TER Lai Division of Cardiovascular Diseases
- Chun-Yuan Chu Division of Cardiovascular Diseases
- Hsiang Chun Lee Division of Cardiovascular Diseases
- 吳韋璁 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
- Wei-Ting Chang 未分科
- 施志遠 Division of Cardiovascular Diseases
- Zhih-Cherng Chen Division of Cardiovascular Diseases
- Chia-Te Liao Division of Cardiovascular Diseases
- 洪俊聲 Division of Cardiovascular Diseases
- 黃柏森 Division of Cardiovascular Diseases
- 周銘霆 Division of Cardiovascular Diseases
- 蔣俊彥 Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Po-Tseng Lee Division of Cardiovascular Diseases
- Ju-Yi Chen Division of Cardiovascular Diseases
- 林志展 Division of Cardiovascular Diseases
- 黃成偉 Division of Cardiovascular Diseases
- 李文煌 Division of Cardiovascular Diseases
- Chih-Hsin Hsu Division of Cardiovascular Diseases
- Ping-Yen Liu Division of Cardiovascular Diseases
- Cheng-Han Lee Division of Cardiovascular Diseases
- 陳柏偉 Division of Cardiovascular Diseases
- Po-Sheng Chen Division of Cardiovascular Diseases
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
- Chien-Yi Hsu Division of Cardiovascular Diseases
- Chun-Ming Shih Division of Cardiovascular Diseases
- 陳志維 Division of Cardiovascular Diseases
- Tsung-Lin Yang Division of Cardiovascular Diseases
- 蕭卜源 Division of Cardiovascular Diseases
- Yung-Ta Kao 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
- 林克隆 Division of Rehabilitation Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Taiwan National PI
Co-Principal Investigator
- Tse-Min Lu Division of Family Medicine
- 吳承學 Division of Cardiovascular Diseases
- Shih-Hsien Sung Division of Cardiovascular Diseases
- 黃偉銘 Division of Cardiovascular Diseases
- Hao-min Cheng 教學部
- 張俊欽 Division of Cardiovascular Diseases
- Wen-Chung Yu Division of Cardiovascular Diseases
- 黃少嵩 Division of Family Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- CHO-KAI WU Division of General Internal Medicine
- - - Division of General Internal Medicine
- JEN-KUANG LEE Division of General Internal Medicine
- 黃冠智 Division of General Internal Medicine
- 陳文翔 Division of General Internal Medicine
- YEN-HUNG LIN Division of General Internal Medicine
- 莊泓叡 Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
5 Study ended
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
• KCCQ-TSS change from baseline at 16 weeks compared with placebo
• 6MWD change from baseline at 16 weeks compared with placebo
Inclution Criteria
2. Documented stable symptomatic HF (New York Heart Association Class II-IV) for at least 1 month at Screening (Visit 1), and typical symptoms and signs of HF since at least 1 month (transient HF in the setting of an MI does not qualify) prior to Screening (Visit 1) as defined in Appendix G. Participants must be receiving an oral diuretic agent for at least 1 month prior to Visit 1 with no more than 50% dose adjustment in the last month.
3. LVEF > 40%, documented by the most recent echocardiogram, or cardiac magnetic resonance imaging within the last 12 months prior to Screening (Visit 1). All participants will undergo a local echocardiogram at the Screening (Visit 1) with central reading to confirm the LVEF > 40% eligibility criteria before randomisation.
4. 6MWD ≥ 30 meters and ≤ 400 meters at Screening (Visit 1) and Randomisation (Visit 3). Difference in 6MWD between Screening and Randomisation must be < 50 meters.
Exclusion Criteria
2. Systolic blood pressure < 90 mmHg or ≥ 160 mmHg if not on treatment with ≥ 3 BP lowering medications or ≥ 180 mmHg irrespective of treatments at Randomisation (Visit 3)
3. Heart rate > 110 bpm or < 50 bpm at Randomisation (Visit 3).
4. Life expectancy < 3 years due to other reasons than cardiovascular disease.
The Estimated Number of Participants
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Taiwan
270 participants
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Global
2450 participants
