Clinical Trials List
Protocol NumberCRD-4730-210
Not yet recruiting
2026-09-01 - 2029-06-30
Phase II
Not yet recruiting4
A phase 2, randomized, double-blind, placebo-controlled trial was conducted to evaluate the efficacy, safety, and tolerability of CRD-4730 in patients with heart failure with reduced ejection fraction (HFrEF).
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Trial Applicant
MEDPACE TAIWAN LIMITED
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Sponsor
Medpace Taiwan Limited.
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Trial scale
Multi-Regional Multi-Center
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Update
2026/09/11
Investigators and Locations
Co-Principal Investigator
- 何鴻鋆 Division of Cardiovascular Diseases
- Shang-Ju Wu Division of Cardiovascular Diseases
- 王奇彥 Division of Cardiovascular Diseases
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
- 林重佑 Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Principal Investigator
I-Chang Hsieh
Co-Principal Investigator
- 謝明哲 Division of Cardiovascular Diseases
- 陳俊吉 Division of Cardiovascular Diseases
- 何明昀 Division of Cardiovascular Diseases
- 葉日凱 Division of Cardiovascular Diseases
- 張伯丞 Division of Cardiovascular Diseases
- 陳東藝 Division of Cardiovascular Diseases
- 沃宏達 Division of Cardiovascular Diseases
- 王朝永 Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Condition/Disease
Heart failure with reduced ejection fraction
Objectives
To confirm whether the investigational drug CRD-4730 can improve cardiac function in patients with heart failure with reduced ejection fraction (HFrEF).
Test Drug
CRD-4730
Active Ingredient
CRD-4730
CRD-4730
CRD-4730
Dosage Form
Tablets
Dosage
50 mg
100 mg
100 mg
Endpoints
Assessment was conducted at 12 and 24 weeks post-treatment based on a composite functional score of multiple cardiac-related measurements. These measurements included the cardiac biomarker N-terminal pro-B-type natriuretic peptide (NT-proBNP, a marker of cardiac pressure), and cardiac angiography using echocardiography (an ultrasound scan) to measure heart size and function (the heart's filling and emptying capacity).
Inclution Criteria
To be eligible to participate in this trial, participants must meet all of the following criteria:
1. Be able to understand and be willing to comply with all trial procedures during the planned follow-up period, understand the risks involved in the trial, and provide written informed consent.
2. Be an adult male or female patient aged 18 years or older and under 85 years of age at the time of screening.
3. Have a medical history supporting a diagnosis of clinical chronic heart failure syndrome that has persisted for at least 8 weeks prior to screening, and New York Heart Association functional class II or III (based on the assessment of the trial administrator).
4. Have a centrally interpreted precordial echocardiogram (TTE) during screening showing a left ventricular ejection fraction (EF) ≤40%.
5. Have an N-terminal pro-B-type natriuretic peptide (NT-proBNP) concentration ≥600 pg/mL (70.8 pmol/L) at the time of screening. For patients with atrial fibrillation or flutter at screening, the NT-proBNP concentration must be ≥900 pg/mL (106.4 pmol/L);
6. Currently receiving optimized and stable guideline-guided treatment for heart failure (according to applicable regional or national guidelines). Stable therapy is defined as no new drug class introduced within 8 weeks prior to screening or during screening (including intravenous iron replacement therapy), and receiving a stable, optimized dose for at least 4 weeks prior to screening and during screening (excluding diuretics).
7. Female participants must meet at least one of the following criteria:
a. Non-fertile women (WOCBP) (as defined in the trial protocol)
b. Fertility-promoting women (as defined in the trial protocol) who agree to use a highly effective method of contraception and an additional effective (barrier) method of contraception, as defined in the trial protocol, for a period of 33 days (one menstrual cycle [30 days] plus 5 half-lives [approximately 3 days]) from the date of screening until the last dose of the trial intervention. Furthermore, fertility-promoting women must agree not to donate eggs for a period of 33 days (30 days plus 5 half-lives) from the date of screening until the last dose of the trial intervention. 8. Male participants must meet at least one of the following criteria:
a. Permanently sterilized (defined as having undergone bilateral orchiectomy)
b. Agree to all of the following:
i. Male participants with fertile female partners must agree to use male condoms (with or without spermicide) from screening until 93 days after the last dose of the trial intervention (estimated spermatogenesis cycle [90 days] plus 5 half-lives [approximately 3 days]). In addition, the fertile female partner should use a highly effective method of contraception (as defined in the trial protocol) during the same period.
ii. From screening until 93 days (90 days plus 5 half-lives) after the last dose of the trial intervention, male participants must agree not to donate sperm.
1. Be able to understand and be willing to comply with all trial procedures during the planned follow-up period, understand the risks involved in the trial, and provide written informed consent.
2. Be an adult male or female patient aged 18 years or older and under 85 years of age at the time of screening.
3. Have a medical history supporting a diagnosis of clinical chronic heart failure syndrome that has persisted for at least 8 weeks prior to screening, and New York Heart Association functional class II or III (based on the assessment of the trial administrator).
4. Have a centrally interpreted precordial echocardiogram (TTE) during screening showing a left ventricular ejection fraction (EF) ≤40%.
5. Have an N-terminal pro-B-type natriuretic peptide (NT-proBNP) concentration ≥600 pg/mL (70.8 pmol/L) at the time of screening. For patients with atrial fibrillation or flutter at screening, the NT-proBNP concentration must be ≥900 pg/mL (106.4 pmol/L);
6. Currently receiving optimized and stable guideline-guided treatment for heart failure (according to applicable regional or national guidelines). Stable therapy is defined as no new drug class introduced within 8 weeks prior to screening or during screening (including intravenous iron replacement therapy), and receiving a stable, optimized dose for at least 4 weeks prior to screening and during screening (excluding diuretics).
7. Female participants must meet at least one of the following criteria:
a. Non-fertile women (WOCBP) (as defined in the trial protocol)
b. Fertility-promoting women (as defined in the trial protocol) who agree to use a highly effective method of contraception and an additional effective (barrier) method of contraception, as defined in the trial protocol, for a period of 33 days (one menstrual cycle [30 days] plus 5 half-lives [approximately 3 days]) from the date of screening until the last dose of the trial intervention. Furthermore, fertility-promoting women must agree not to donate eggs for a period of 33 days (30 days plus 5 half-lives) from the date of screening until the last dose of the trial intervention. 8. Male participants must meet at least one of the following criteria:
a. Permanently sterilized (defined as having undergone bilateral orchiectomy)
b. Agree to all of the following:
i. Male participants with fertile female partners must agree to use male condoms (with or without spermicide) from screening until 93 days after the last dose of the trial intervention (estimated spermatogenesis cycle [90 days] plus 5 half-lives [approximately 3 days]). In addition, the fertile female partner should use a highly effective method of contraception (as defined in the trial protocol) during the same period.
ii. From screening until 93 days (90 days plus 5 half-lives) after the last dose of the trial intervention, male participants must agree not to donate sperm.
Exclusion Criteria
Participants meeting any of the following criteria will be ineligible for this trial:
1. Insufficient phonowindow according to the core laboratory assessment of the screening echocardiogram.
2. Evidence of recent worsening of heart failure within 4 weeks prior to or during screening, defined as hospitalization or the need for intravenous (IV) or subcutaneous (SQ) diuretics.
3. Requirement of routine, scheduled outpatient IV infusions for heart failure (i.e., cardiotonics, vasodilators, or diuretics) or routine scheduled ultrafiltration. Repeat administration of IV iron replacement therapy may be permitted at the discretion of the trial administrator if clinically necessary, but IV iron replacement therapy must have been initiated >8 weeks prior to screening.
4. A corrected QT interval (QTc) (Fridericia formula) ≥ 450 ms at screening, corrected for QRS if necessary. For eligibility assessment, the formula provided in the trial protocol will be used to correct the QT for the extended QRS.
Note: QTm (estimated QT interval after QRS correction) will be used to calculate the corrected QT interval using the Fridericia formula. Potential participants without extended QRS will only have their corrected QT interval calculated using the Fridericia formula (QTm calculation is not required).
5. Known family history of long QT syndrome in a first-degree relative.
6. Currently receiving long-term treatment with Vaughan Williams Class I or III antiarrhythmic medication.
7. Recently started (<2 weeks prior to screening) on any medication known to prolong the QT interval.
8. Laboratory evidence of untreated hypothyroidism at screening, defined as serum thyroid-stimulating hormone (TSH) concentration above the upper limit of normal.
9. Electrolyte imbalance at screening, defined as serum potassium, albumin-corrected serum calcium, or serum magnesium concentration below the lower limit of normal.
10. Plan to undergo elective interventional procedures (e.g., percutaneous coronary intervention, first-time implantation of a medical device, percutaneous interventional treatment for structural heart disease, or major cardiac or non-cardiac surgery) during participation in this trial, or have undergone such elective procedures within 8 weeks prior to or during the screening period.
11. Have experienced acute coronary syndrome, unstable angina, persistent angina at rest, stroke, transient ischemic attack, cardiac, carotid, or other major cardiovascular surgery, heart valve repair (surgical or non-surgical) or replacement, or carotid angioplasty within 8 weeks prior to or during the screening period.
12. Clinically suspected infiltrative cardiomyopathy (e.g., amyloid, sarcoma-like), hypertrophic cardiomyopathy (obstructive or non-obstructive), or secondary to severe valvular disease, active myocarditis, active pericarditis, or clinically significant congenital heart disease with heart failure.
13. Has received or plans to receive orthotopic heart transplantation (acceptable for inclusion on the transplant list, provided the trial administrator does not anticipate a transplant within the next year).
14. Has mechanical circulatory support or plans to use it.
15. Known bleeding tendency.
16. Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m² at screening time, calculated using the 2021 formula of the Chronic Kidney Disease Epidemiology Collaborative Study Group, or is determined by the trial administrator to have rapidly deteriorating kidney disease at screening time.
17. Evidence of hepatic impairment at screening time, defined as alanine transaminase/aspartate transaminase >3 × upper limit of normal (ULN) and/or total bilirubin >1.5 × ULN; Note: Patients diagnosed with Gilbert's syndrome and with total bilirubin >1.5 × ULN may be included if their direct bilirubin at screening time is ≤ ULN.
18. Evidence of anemia at screening, defined as hemoglobin <12 g/dL.
19. Received a concentrated red blood cell transfusion within 4 weeks prior to or during screening.
20. Platelet count <100,000 cells/mm3 at screening, or a known history of a platelet count <100,000 cells/mm3 within 8 weeks prior to screening.
21. Absolute neutrophil count <1000 cells/mm3 at screening.
22. Clinically suspected latent gastrointestinal bleeding based on the trial administrator's assessment at screening.
23. Currently using a drug, food, herbal remedy, or substance known to be a potent inhibitor or inducer of cytochrome P450 3A4 (CYP3A4), or a potent inhibitor of P-glycoprotein. Patients who have previously received amiodarone (a potent P-glycoprotein [P-gp] inhibitor) must discontinue amiodarone treatment for >3 months prior to screening to be eligible.
24. Concurrent participation in other interventional clinical trials, or receiving other experimental interventions within 4 weeks prior to randomization or within 5 half-lives of the other experimental intervention, whichever is longer; Note: Patients may concurrently participate in non-invasive observational trials that will not affect the validity of this trial's results.
25. A history of alcohol or drug abuse, as determined by the trial administrator, that may interfere with the patient's ability to adhere to the trial protocol.
26. Evidence of clinically significant cardiovascular, endocrine, gastrointestinal, hematological, hepatic, immunological, neurological, neoplastic, pulmonary, psychiatric, or renal disease (i.e., acute kidney injury), or any other condition, as determined by the trial administrator, that cannot be explained by a diagnosis of heart failure and will jeopardize patient safety or affect the validity of the trial results.
27. A history of malignant tumors, excluding patients who have been disease-free for >5 years prior to screening, or patients whose only malignant tumor is successfully treated basal or squamous cell skin cancer.
28. Positive for hepatitis B surface antigen (HBsAg), human immunodeficiency virus (HIV) antibody, or hepatitis C virus (HCV) antibody (anti-HCV) plus hepatitis C virus RNA (HCV-RNA) through central laboratory testing. Patients who are anti-HCV positive but HCV-RNA negative (secondary to treatment or natural viral clearance) are eligible to participate if at least 12 months have passed since the date the record shows a negative RNA polymerase chain reaction (PCR) result after the completion of treatment.
29. Currently pregnant or lactating, where pregnancy is defined as the state from the time of conception until the termination of pregnancy, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test.
30. A history of allergy/allergic reaction to CRD-4730 or any of the excipients, which the trial administrator deems would endanger the safety of the participants.
31. Employed by Cardurion, or a person employed by Cardurion, the trial administrator, their staff, or a relative of one of their family members.
1. Insufficient phonowindow according to the core laboratory assessment of the screening echocardiogram.
2. Evidence of recent worsening of heart failure within 4 weeks prior to or during screening, defined as hospitalization or the need for intravenous (IV) or subcutaneous (SQ) diuretics.
3. Requirement of routine, scheduled outpatient IV infusions for heart failure (i.e., cardiotonics, vasodilators, or diuretics) or routine scheduled ultrafiltration. Repeat administration of IV iron replacement therapy may be permitted at the discretion of the trial administrator if clinically necessary, but IV iron replacement therapy must have been initiated >8 weeks prior to screening.
4. A corrected QT interval (QTc) (Fridericia formula) ≥ 450 ms at screening, corrected for QRS if necessary. For eligibility assessment, the formula provided in the trial protocol will be used to correct the QT for the extended QRS.
Note: QTm (estimated QT interval after QRS correction) will be used to calculate the corrected QT interval using the Fridericia formula. Potential participants without extended QRS will only have their corrected QT interval calculated using the Fridericia formula (QTm calculation is not required).
5. Known family history of long QT syndrome in a first-degree relative.
6. Currently receiving long-term treatment with Vaughan Williams Class I or III antiarrhythmic medication.
7. Recently started (<2 weeks prior to screening) on any medication known to prolong the QT interval.
8. Laboratory evidence of untreated hypothyroidism at screening, defined as serum thyroid-stimulating hormone (TSH) concentration above the upper limit of normal.
9. Electrolyte imbalance at screening, defined as serum potassium, albumin-corrected serum calcium, or serum magnesium concentration below the lower limit of normal.
10. Plan to undergo elective interventional procedures (e.g., percutaneous coronary intervention, first-time implantation of a medical device, percutaneous interventional treatment for structural heart disease, or major cardiac or non-cardiac surgery) during participation in this trial, or have undergone such elective procedures within 8 weeks prior to or during the screening period.
11. Have experienced acute coronary syndrome, unstable angina, persistent angina at rest, stroke, transient ischemic attack, cardiac, carotid, or other major cardiovascular surgery, heart valve repair (surgical or non-surgical) or replacement, or carotid angioplasty within 8 weeks prior to or during the screening period.
12. Clinically suspected infiltrative cardiomyopathy (e.g., amyloid, sarcoma-like), hypertrophic cardiomyopathy (obstructive or non-obstructive), or secondary to severe valvular disease, active myocarditis, active pericarditis, or clinically significant congenital heart disease with heart failure.
13. Has received or plans to receive orthotopic heart transplantation (acceptable for inclusion on the transplant list, provided the trial administrator does not anticipate a transplant within the next year).
14. Has mechanical circulatory support or plans to use it.
15. Known bleeding tendency.
16. Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m² at screening time, calculated using the 2021 formula of the Chronic Kidney Disease Epidemiology Collaborative Study Group, or is determined by the trial administrator to have rapidly deteriorating kidney disease at screening time.
17. Evidence of hepatic impairment at screening time, defined as alanine transaminase/aspartate transaminase >3 × upper limit of normal (ULN) and/or total bilirubin >1.5 × ULN; Note: Patients diagnosed with Gilbert's syndrome and with total bilirubin >1.5 × ULN may be included if their direct bilirubin at screening time is ≤ ULN.
18. Evidence of anemia at screening, defined as hemoglobin <12 g/dL.
19. Received a concentrated red blood cell transfusion within 4 weeks prior to or during screening.
20. Platelet count <100,000 cells/mm3 at screening, or a known history of a platelet count <100,000 cells/mm3 within 8 weeks prior to screening.
21. Absolute neutrophil count <1000 cells/mm3 at screening.
22. Clinically suspected latent gastrointestinal bleeding based on the trial administrator's assessment at screening.
23. Currently using a drug, food, herbal remedy, or substance known to be a potent inhibitor or inducer of cytochrome P450 3A4 (CYP3A4), or a potent inhibitor of P-glycoprotein. Patients who have previously received amiodarone (a potent P-glycoprotein [P-gp] inhibitor) must discontinue amiodarone treatment for >3 months prior to screening to be eligible.
24. Concurrent participation in other interventional clinical trials, or receiving other experimental interventions within 4 weeks prior to randomization or within 5 half-lives of the other experimental intervention, whichever is longer; Note: Patients may concurrently participate in non-invasive observational trials that will not affect the validity of this trial's results.
25. A history of alcohol or drug abuse, as determined by the trial administrator, that may interfere with the patient's ability to adhere to the trial protocol.
26. Evidence of clinically significant cardiovascular, endocrine, gastrointestinal, hematological, hepatic, immunological, neurological, neoplastic, pulmonary, psychiatric, or renal disease (i.e., acute kidney injury), or any other condition, as determined by the trial administrator, that cannot be explained by a diagnosis of heart failure and will jeopardize patient safety or affect the validity of the trial results.
27. A history of malignant tumors, excluding patients who have been disease-free for >5 years prior to screening, or patients whose only malignant tumor is successfully treated basal or squamous cell skin cancer.
28. Positive for hepatitis B surface antigen (HBsAg), human immunodeficiency virus (HIV) antibody, or hepatitis C virus (HCV) antibody (anti-HCV) plus hepatitis C virus RNA (HCV-RNA) through central laboratory testing. Patients who are anti-HCV positive but HCV-RNA negative (secondary to treatment or natural viral clearance) are eligible to participate if at least 12 months have passed since the date the record shows a negative RNA polymerase chain reaction (PCR) result after the completion of treatment.
29. Currently pregnant or lactating, where pregnancy is defined as the state from the time of conception until the termination of pregnancy, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test.
30. A history of allergy/allergic reaction to CRD-4730 or any of the excipients, which the trial administrator deems would endanger the safety of the participants.
31. Employed by Cardurion, or a person employed by Cardurion, the trial administrator, their staff, or a relative of one of their family members.
The Estimated Number of Participants
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Taiwan
16 participants
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Global
525 participants
