Back to resultsShengxian Quyu Decoction in the Treatment of Heart Failure With Reduced Ejection Fraction
Primary Purpose
Heart Failure With Reduced Ejection Fraction
Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Shengxian Quyu Decoction
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure With Reduced Ejection Fraction focused on measuring Shengxian Quyu Decoction, Heart failure with reduced ejection fraction, Quality of Life, Symtoms, Biomarkers, Multicenter, Randomized
Eligibility Criteria
Inclusion Criteria:
- Male or female, aged ≥18 years at the time of consent.
- Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV).
- LVEF<40%.
- NT-proBNP >600 pg/ml or BNP ≥150 pg/ml (or if hospitalized for heart failure within the previous 12 months, NT-proBNP ≥400 pg/ml or BNP ≥100 pg/ml) at enrolment.
- Provision of signed informed consent prior to any study specific procedures.
Exclusion Criteria:
- Current acute decompensated HF or hospitalization due to decompensated HF, ACS, stroke or transient ischemic attack (TIA), coronary revascularization (percutaneous coronary intervention [PCI] or coronary artery bypass grafting [CABG]) or valvular repair/replacement, or other major cardiovascular surgery within 4 weeks prior to enrolment.
- Uncontrolled severe arrhythmia.
- Planned to undergo heart transplantation or device implantation.
- 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).
- Severe infection.
- eGFR <30 mL/min/1.73 m^2 by CKD-EPI.
- Active malignancy requiring treatment at the time of visit 1.
- Women of child-bearing potential 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.
- Any condition outside the CV and renal disease area, such as but not limited to malignancy, with a life expectancy of less than 1 years based on investigator's clinical judgement.
- Systolic blood pressure < 90 mmHg, or systolic blood pressure ≥ 180 mmHg, or diastolic blood pressure ≥ 110 mmHg on 2 consecutive measurements.
- Heart failure due to infiltrative cardiomyopathies(cardiac amyloidosis, etc.), fulminant myocarditis, constrictive pericarditis.
- Participation in another clinical study.
- 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.
Sites / Locations
- China-Japan Friendship HospitalRecruiting
- Tangxian County Traditional Chinese Medicine HospitalRecruiting
- Gongyi City People's HospitalRecruiting
- The Affiliated Hospital of Qingdao UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Shengxian Quyu Decoction
placebo
Arm Description
Patients will be randomized 1:1 to either Shengxian Quyu Decoction or placebo. "Shengxian Quyu Decoction" (calculated by a medicine): 30g of Astragalus membranaceus (Huangqi), 12g of Cornus officinalis (Shanzhuyu), 9g of Talinum paniculatum (Jacq.) Gaertn. (Hongshen), 12g of Rhizoma Anemarrhena (Zhimu), 8g of Rhizoma Cimicifugae (Shengma), 8g of Radix Bupleuri (Chaihu), 10g of Platycodon grandiflorum (Jiegeng), 10g of Rhizoma Sparganii (Sanleng), 9g of Rhizoma Curcumae (Ezhu), 3g of Whitmania pigra Whitman (Shuizhi).
Placebo matching Shengxian Quyu Decoction
Outcomes
Primary Outcome Measures
Change From Baseline in the KCCQ Clinical Summary Score
KCCQ was a 23-item, self-administered questionnaire that measure the participant's perception of their health status, including their heart failure (HF) symptoms, impact on physical and social function and how their HF impacts the quality of life. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 to 100, with 0 denoting the worst and 100 the best possible status. KCCQ-clinical summary score was average of domains- physical limitation and total symptoms (average of symptom frequency and symptom burden), and transformed to a single score which ranged from 0 (worst) -100 (the best possible status), where the higher score reflected better health status.
Secondary Outcome Measures
Change From Baseline in the Traditional Chinese Medicine Syndrome Score Scale (TCMSSS)
Traditional Chinese Medicine Syndrome Score is a instrument that quantifies symptoms. Lower TCM scores reflect better health status.
Change in Exercise Capacity as Measured by the 6-Minutes-Walking-Test (6MWT) Distance
Change from baseline to week 12 in exercise capacity as measured by the distance walked in 6 minutes in standardised conditions. Change from baseline was defined as the distance walked in 6 minutes at week 12 minus the baseline value. Baseline value was defined as the last available measurement before start of treatment with randomised study medication.
Change in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP)
Change from baseline to week 12 in N-terminal pro-brain natriuretic peptide (NT-proBNP). Baseline value was defined as the mean of all available measurements from the screening visit until start of treatment with randomised study medication.
Change in Left Ventricular Systolic Function
Change in left ventricular ejection fraction is assessed by two-dimensional directed M-mode echocardiography.
Change in Left Ventricular End-Diastolic Diameter
Change in left ventricular end-diastolic diameter is assessed by two-dimensional directed M-mode echocardiography.
Change in Left Ventricular End-Systolic Diameter
Change in left ventricular end-systolic diameter is assessed by two-dimensional directed M-mode echocardiography.
Change in Estimated Glomerular Filtration Rate from Baseline
Estimated glomerular filtration rate (eGFR) is calculated by the CKD-EPI equation.
Change From Baseline in the KCCQ Clinical Summary Score
KCCQ was a 23-item, self-administered questionnaire that measure the participant's perception of their health status, including their heart failure (HF) symptoms, impact on physical and social function and how their HF impacts the quality of life. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 to 100, with 0 denoting the worst and 100 the best possible status. KCCQ-clinical summary score was average of domains- physical limitation and total symptoms (average of symptom frequency and symptom burden), and transformed to a single score which ranged from 0 (worst) -100 (the best possible status), where the higher score reflected better health status.
Change From Baseline in the Traditional Chinese Medicine Syndrome Score Scale (TCMSSS)
Traditional Chinese Medicine Syndrome Score is a instrument that quantifies symptoms. Lower TCM scores reflect better health status.
Full Information
NCT ID
NCT05583773
First Posted
October 8, 2022
Last Updated
May 9, 2023
Sponsor
China-Japan Friendship Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05583773
Brief Title
Shengxian Quyu Decoction in the Treatment of Heart Failure With Reduced Ejection Fraction
Official Title
Effects of "Shengxian Quyu Decoction" on Quality of Life, Symptoms, and Biomarkers in Heart Failure Patients With Reduced Ejection Fraction: A Multicenter, Randomized Clinical Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 29, 2023 (Actual)
Primary Completion Date
April 30, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
China-Japan Friendship Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to conduct a multicenter, randomized clinical trial to evaluate the effect of "Shengxian Quyu Decoction" on quality of life , symptoms, and biomarkers in heart failure patients with reduced ejection fraction.
Detailed Description
This is a multicenter, prospective, randomised, placebo-controlled study in patients with chronic heart failure with reduced ejection fraction (HFrEF), evaluating the effect of "Shengxian Quyu Decoction" versus placebo, given twice daily in addition to background regional standard of care therapy. The effect of "Shengxian Quyu Decoction"on quality of life, symptoms and biomarkers will be evaluated.
The primary and secondary endpoints will be examined in subgroups determined by baseline variables reflecting demography, heart failure characteristics, Traditional Chinese Medicine syndrome type, diabetes status, kidney function, left ventricular ejection fraction, natriuretic peptide, and additional co-morbidities, concomitant medications, and others.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure With Reduced Ejection Fraction
Keywords
Shengxian Quyu Decoction, Heart failure with reduced ejection fraction, Quality of Life, Symtoms, Biomarkers, Multicenter, Randomized
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
308 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Shengxian Quyu Decoction
Arm Type
Active Comparator
Arm Description
Patients will be randomized 1:1 to either Shengxian Quyu Decoction or placebo. "Shengxian Quyu Decoction" (calculated by a medicine): 30g of Astragalus membranaceus (Huangqi), 12g of Cornus officinalis (Shanzhuyu), 9g of Talinum paniculatum (Jacq.) Gaertn. (Hongshen), 12g of Rhizoma Anemarrhena (Zhimu), 8g of Rhizoma Cimicifugae (Shengma), 8g of Radix Bupleuri (Chaihu), 10g of Platycodon grandiflorum (Jiegeng), 10g of Rhizoma Sparganii (Sanleng), 9g of Rhizoma Curcumae (Ezhu), 3g of Whitmania pigra Whitman (Shuizhi).
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Placebo matching Shengxian Quyu Decoction
Intervention Type
Drug
Intervention Name(s)
Shengxian Quyu Decoction
Intervention Description
Specification: 30ml/bag, given twice daily, per oral use.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo matching Shengxian Quyu Decoction, 30ml/bag, given twice daily, per oral use.
Primary Outcome Measure Information:
Title
Change From Baseline in the KCCQ Clinical Summary Score
Description
KCCQ was a 23-item, self-administered questionnaire that measure the participant's perception of their health status, including their heart failure (HF) symptoms, impact on physical and social function and how their HF impacts the quality of life. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 to 100, with 0 denoting the worst and 100 the best possible status. KCCQ-clinical summary score was average of domains- physical limitation and total symptoms (average of symptom frequency and symptom burden), and transformed to a single score which ranged from 0 (worst) -100 (the best possible status), where the higher score reflected better health status.
Time Frame
Up to 12 weeks
Secondary Outcome Measure Information:
Title
Change From Baseline in the Traditional Chinese Medicine Syndrome Score Scale (TCMSSS)
Description
Traditional Chinese Medicine Syndrome Score is a instrument that quantifies symptoms. Lower TCM scores reflect better health status.
Time Frame
Up to 12 weeks
Title
Change in Exercise Capacity as Measured by the 6-Minutes-Walking-Test (6MWT) Distance
Description
Change from baseline to week 12 in exercise capacity as measured by the distance walked in 6 minutes in standardised conditions. Change from baseline was defined as the distance walked in 6 minutes at week 12 minus the baseline value. Baseline value was defined as the last available measurement before start of treatment with randomised study medication.
Time Frame
Up to 12 weeks
Title
Change in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP)
Description
Change from baseline to week 12 in N-terminal pro-brain natriuretic peptide (NT-proBNP). Baseline value was defined as the mean of all available measurements from the screening visit until start of treatment with randomised study medication.
Time Frame
Up to 12 weeks
Title
Change in Left Ventricular Systolic Function
Description
Change in left ventricular ejection fraction is assessed by two-dimensional directed M-mode echocardiography.
Time Frame
Up to 12 weeks
Title
Change in Left Ventricular End-Diastolic Diameter
Description
Change in left ventricular end-diastolic diameter is assessed by two-dimensional directed M-mode echocardiography.
Time Frame
Up to 12 weeks
Title
Change in Left Ventricular End-Systolic Diameter
Description
Change in left ventricular end-systolic diameter is assessed by two-dimensional directed M-mode echocardiography.
Time Frame
Up to 12 weeks
Title
Change in Estimated Glomerular Filtration Rate from Baseline
Description
Estimated glomerular filtration rate (eGFR) is calculated by the CKD-EPI equation.
Time Frame
Up to 12 weeks
Title
Change From Baseline in the KCCQ Clinical Summary Score
Description
KCCQ was a 23-item, self-administered questionnaire that measure the participant's perception of their health status, including their heart failure (HF) symptoms, impact on physical and social function and how their HF impacts the quality of life. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 to 100, with 0 denoting the worst and 100 the best possible status. KCCQ-clinical summary score was average of domains- physical limitation and total symptoms (average of symptom frequency and symptom burden), and transformed to a single score which ranged from 0 (worst) -100 (the best possible status), where the higher score reflected better health status.
Time Frame
Up to 26 weeks
Title
Change From Baseline in the Traditional Chinese Medicine Syndrome Score Scale (TCMSSS)
Description
Traditional Chinese Medicine Syndrome Score is a instrument that quantifies symptoms. Lower TCM scores reflect better health status.
Time Frame
Up to 26 weeks
Other Pre-specified Outcome Measures:
Title
Subjects Included in the Composite Endpoint of Cardiovascular Death and Worsening Heart Failure
Description
The composite CV endpoint is defined as cardiovascular death, hospitalization due to heart failure or urgent visit required intravenous treatment due to heart failure.
Time Frame
Up to 12 weeks
Title
Subjects Included in the Composite Endpoint of Cardiovascular Death and Worsening Heart Failure
Description
The composite CV endpoint is defined as cardiovascular death, hospitalization due to heart failure or urgent visit required intravenous treatment due to heart failure.
Time Frame
Up to 26 weeks
Title
Renal Composite Endpoint
Description
The renal composite endpoint included composite of doubling of serum creatinine (DoSC), end-stage kidney disease (ESKD), and renal death. DoSC: from the baseline average determination (sustained and confirmed by repeat central laboratory measure after at least 30 days and preferably within 60 days). ESKD: initiation of maintenance dialysis for at least 30 days, or renal transplantation, or an eGFR value of <15 mL/min/1.73 m^2 (sustained and confirmed by repeat central laboratory measure after at least 30 days and preferably within 60 days). Renal death: death in participants who have reached ESKD, died without initiating renal replacement therapy, and no other cause of death was determined via adjudication. Adjudication of these events by the EAC was performed in a blinded fashion. Event rate estimated based on the time to the first occurrence of the renal composite endpoint are presented.
Time Frame
Up to 12 weeks
Title
Renal Composite Endpoint
Description
The renal composite endpoint included composite of doubling of serum creatinine (DoSC), end-stage kidney disease (ESKD), and renal death. DoSC: from the baseline average determination (sustained and confirmed by repeat central laboratory measure after at least 30 days and preferably within 60 days). ESKD: initiation of maintenance dialysis for at least 30 days, or renal transplantation, or an eGFR value of <15 mL/min/1.73 m^2 (sustained and confirmed by repeat central laboratory measure after at least 30 days and preferably within 60 days). Renal death: death in participants who have reached ESKD, died without initiating renal replacement therapy, and no other cause of death was determined via adjudication. Adjudication of these events by the EAC was performed in a blinded fashion. Event rate estimated based on the time to the first occurrence of the renal composite endpoint are presented.
Time Frame
Up to 26 weeks
Title
Liver Injury
Description
Liver injury is defined as: i) a rise of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) to 3 times above the upper limit of normal [ULN], or ii) a rise of total bilirubin to 2 times above the upper limit of normal [ULN].
Time Frame
Up to 12 weeks
Title
Liver Injury
Description
Liver injury is defined as: i) a rise of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) to 3 times above the upper limit of normal [ULN], or ii) a rise of total bilirubin to 2 times above the upper limit of normal [ULN].
Time Frame
Up to 26 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female, aged ≥18 years at the time of consent.
Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV).
LVEF<40%.
NT-proBNP >600 pg/ml or BNP ≥150 pg/ml (or if hospitalized for heart failure within the previous 12 months, NT-proBNP ≥400 pg/ml or BNP ≥100 pg/ml) at enrolment.
Provision of signed informed consent prior to any study specific procedures.
Exclusion Criteria:
Current acute decompensated HF or hospitalization due to decompensated HF, ACS, stroke or transient ischemic attack (TIA), coronary revascularization (percutaneous coronary intervention [PCI] or coronary artery bypass grafting [CABG]) or valvular repair/replacement, or other major cardiovascular surgery within 4 weeks prior to enrolment.
Uncontrolled severe arrhythmia.
Planned to undergo heart transplantation or device implantation.
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).
Severe infection.
eGFR <30 mL/min/1.73 m^2 by CKD-EPI.
Active malignancy requiring treatment at the time of visit 1.
Women of child-bearing potential 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.
Any condition outside the CV and renal disease area, such as but not limited to malignancy, with a life expectancy of less than 1 years based on investigator's clinical judgement.
Systolic blood pressure < 90 mmHg, or systolic blood pressure ≥ 180 mmHg, or diastolic blood pressure ≥ 110 mmHg on 2 consecutive measurements.
Heart failure due to infiltrative cardiomyopathies(cardiac amyloidosis, etc.), fulminant myocarditis, constrictive pericarditis.
Participation in another clinical study.
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mengxi Yang, Dr.
Phone
+8615120049452
Email
mxtezuka@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jiang Liu, Dr.
Phone
+8619800361320
Facility Information:
Facility Name
China-Japan Friendship Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiang Liu
Phone
+86 19800361320
Email
674754301@qq.com
Facility Name
Tangxian County Traditional Chinese Medicine Hospital
City
Baoding
State/Province
Hebei
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianfei Guan
Phone
+8613483208655
Facility Name
Gongyi City People's Hospital
City
Gongyi
State/Province
Henan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jijie Wang
Phone
+8613838199975
Facility Name
The Affiliated Hospital of Qingdao University
City
Qingdao
State/Province
Shandong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hui Xin
Phone
+86 18661801287
Email
xinhuiqy@163.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Shengxian Quyu Decoction in the Treatment of Heart Failure With Reduced Ejection Fraction
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