Heart FailurePhase 1NCT06348498
Pharmacokinetic and Pharmacodynamic of Jia Shen Tablets in Chronic Heart Failure
A Phase 1 study testing Jia Shen Tablet in people with Heart Failure, run by Tasly Pharmaceutical Group Co., Ltd at 1 site in China.
Trial summary
Evaluate the pharmacokinetic and pharmacodynamic characteristics of Jia Shen Tablets in patients with Chronic Heart Failure. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Jia Shen Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 9 Apr 2024to 30 Jun 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years, either sex;
- Meet the diagnostic criteria for CHD and CHF;
- Meet the TCM differentiation criteria of yang deficiency and blood stasis in CHF;
- LVEF < 40% (Modified Simpson's Method);
- Class II to IⅢ for NYHA functional classification;
- Receive Steady dose of standard medication for CHF for at least 2 weeks;
- Understand the research requirements and are willing to provide written informed consent.
Who cannot join
- Acute heart failure or acute exacerbation of chronic heart failure;
- HF caused by other heart diseases, such as congenital heart disease, severe stenosis or insufficiency of heart valves, cardiomyopathy (e.g., hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy, dilated cardiomyopathy, alcoholic cardiomyopathy), moderate massive pericardial effusion, constrictive pericarditis, infective endocarditis;
- Patients with acute coronary syndrome within 30 days before receiving the trial drug，and the following situation within 6 months before receiving the trial drug，such as acute myocardial infarction，revascularization (e.g., PCI, CABG) or left ventricular reconstruction surgery, pacemaker implantation for cardiac resynchronization, and undergoing cardiothoracic surgery;
- Expect to receive an implantable device (e.g. ICD, CRT), or revascularization (e.g. PCI, CABG), or other cardiovascular surgery during the trial period;
- Severe arrhythmias [e.g., ventricular tachycardia, second degree type II or higher sinus or atrioventricular block without pacemaker placement, QT interval (QTc) greater than 480 ms after heart rate adjustment according to Fridericia's formula, or known history or symptoms of long QT syndrome];
- Combined with serious diseases of other systems, such as liver, kidney, hematopoietic system and other serious primary diseases, tumors, mental diseases, etc;
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- The presence of uncontrolled hypertension (systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg), or the presence of hypotension (systolic blood pressure < 80 mmHg and/or diastolic blood pressure < 50 mmHg);
- ALT or AST more than 3 times the upper limit of normal, and/or estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73m2;
- Glycosylated hemoglobin (HbA1c) ≥9.0%, or fasting blood glucose ≥13.9 mmol/L;
- Anemia (Hb < 110 g/L for women, Hb < 120 g/L for men);
- Blood potassium is above the upper limit of normal;
- Patients who tested positive for five hepatitis B tests (except surface antibodies) or hepatitis C, or anti-TP or HIV antibodies;
- Patients with a history of drug abuse who test positive for drug abuse (morphine, methamphetamine, ketamine, dimethyldioxyamphetamine, THC, cocaine);
- Women who are pregnant or nursing, or have a need to have children within 3 months after the last dose of the trial;
- Participating in other studies and taking investigational drugs from other studies within 3 months prior to screening;
- Allergic to Jiashen tablets or their ingredients;
- Other situations judged by the researchers to be inappropriate for this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin, Tianjin Municipality
Yuhong Huang
About this study
Official title: A Open Label, Standardise-loaded and Single-Centre Phase Ⅰb Clinical Trial：Pharmacokinetic and Pharmacodynamic of Jia Shen Tablets in Chronic Heart Failure
Evaluate the pharmacokinetic and pharmacodynamic characteristics of Jia Shen Tablets in patients with Chronic Heart Failure.
Read the detailed description
Jia Shen Tablets are oral, compound traditional chinese medicine. This open label, standardise-loaded and single-Centre phase Ⅰb clinical trial will evaluate the pharmacokinetic and pharmacodynamic characteristics of Jia Shen Tablets in treatment of coronary heart disease complicating chronic heart failure (syndrome of Yang deficiency with blood stasis) and preliminarily evaluate the efficacy and safety.
- Conditions
- Heart Failure
- Being tested
- Jia Shen Tablet
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jia Shen TabletDrug
Jia Shen Tablets contain 4 tablets (0.47 g per tablet), take orally, 2 times a day for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Jia Shen Tablet，4 tablets，take orally，2 times a day Receives: Drug: Jia Shen Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic characteristic evaluation：Maximum observed plasma concentration (Cmax)
To characterize the multiple dose PK of Jia Shen Tablets and assess the time required to reach steady state, the degree of accumulation and the time dependency of the PK in patients with Coronary Heart Disease Complicating Chronic Heart Failure (Syndrome of Yang Deficiency with Blood Stasis).
Measured: Day 1,27-30,56,84.
Plasma PK analysis: Time to reach peak or maximum observed concentration following drug administration (Tmax)
To characterize the multiple dose PK of Jia Shen Tablets and assess the time required to reach steady state, the degree of accumulation and the time dependency of the PK in patients with Coronary Heart Disease Complicating Chronic Heart Failure (Syndrome of Yang Deficiency with Blood Stasis).
Measured: Day 1,27-30,56,84.
Plasma PK analysis: Area under curve at steady state (AUCss)
To characterize the multiple dose PK of Jia Shen Tablets and assess the time required to reach steady state, the degree of accumulation and the time dependency of the PK in patients with Coronary Heart Disease Complicating Chronic Heart Failure (Syndrome of Yang Deficiency with Blood Stasis).
Measured: Day 1,27-30,56,84.
Secondary outcomes (5)
NT-proBNP
Change from baseline to weeks 4,8 and 12 in NT-proBNP.
Measured: Baseline to weeks 4,8 and 12.
6-Minutes-Walking-Test (6MWT)
Change from baseline to weeks 4,8 and 12 in exercise capacity as measured by the 6-Minutes-Walking-Test (6MWT) distance.
Measured: Baseline to weeks 4,8 and 12.
Echocardiogram results
Change from baseline to weeks 12 in left ventricular end diastolic diameter(LVEDD) measured by echocardiography.
Change from baseline to weeks 12 in left ventricular end diastolic volume(LVEDV) measured by echocardiography.
Change from baseline to weeks 12 in left ventricular end systolic volume(LVESV) measured by echocardiography.
Change from baseline to weeks 12 in left ventricular ejection fraction(LVEF) measured by echocardiography.
Change from baseline to weeks 12 in stroke volume(SV) measured by echocardiography.
Change from baseline to weeks 12 in cardiac output(CO) measured by echocardiography.
Measured: Baseline to weeks 12.
NYHA classification
Percentage of subjects whose NYHA classification improved/worsened/remained unchanged from baseline to weeks 4,8 and 12.
Measured: Baseline to weeks 4,8 and 12.
AEs
Number of participants with adverse events (AEs).
Measured: From baseline (Day1) till follow-up visit (Up to 12 week).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study start9 Apr 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tasly Pharmaceutical Group Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06348498
- Sponsor's protocol ID
- TSL-TCM-JSP-Ⅰb
- Status last verified
- Mar 2024
- First submitted
- 12 Mar 2024
- Last updated
- 28 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Open Label, Standardise-loaded and Single-Centre Phase Ⅰb Clinical Trial：Pharmacokinetic and Pharmacodynamic of Jia Shen Tablets in Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT06348498
- Acronym / sponsor ID
- TSL-TCM-JSP-Ⅰb
- Conditions
- Heart Failure
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Tasly Pharmaceutical Group Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 9 Apr 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 4 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the pharmacokinetic and pharmacodynamic characteristics of Jia Shen Tablets in patients with Chronic Heart Failure.
Detailed description
Jia Shen Tablets are oral, compound traditional chinese medicine. This open label, standardise-loaded and single-Centre phase Ⅰb clinical trial will evaluate the pharmacokinetic and pharmacodynamic characteristics of Jia Shen Tablets in treatment of coronary heart disease complicating chronic heart failure (syndrome of Yang deficiency with blood stasis) and preliminarily evaluate the efficacy and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Drug: Jia Shen TabletJia Shen Tablet，4 tablets，take orally，2 times a day |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18-75 years, either sex;
- Meet the diagnostic criteria for CHD and CHF;
- Meet the TCM differentiation criteria of yang deficiency and blood stasis in CHF;
- LVEF < 40% (Modified Simpson's Method);
- Class II to IⅢ for NYHA functional classification;
Key exclusion criteria (17 listed)
- Acute heart failure or acute exacerbation of chronic heart failure;
- HF caused by other heart diseases, such as congenital heart disease, severe stenosis or insufficiency of heart valves, cardiomyopathy (e.g., hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy, dilated cardiomyopathy, alcoholic cardiomyopathy), moderate massive pericardial effusion, constrictive pericarditis, infective endocarditis;
- Patients with acute coronary syndrome within 30 days before receiving the trial drug，and the following situation within 6 months before receiving the trial drug，such as acute myocardial infarction，revascularization (e.g., PCI, CABG) or left ventricular reconstruction surgery, pacemaker implantation for cardiac resynchronization, and undergoing cardiothoracic surgery;
- Expect to receive an implantable device (e.g. ICD, CRT), or revascularization (e.g. PCI, CABG), or other cardiovascular surgery during the trial period;
- Severe arrhythmias [e.g., ventricular tachycardia, second degree type II or higher sinus or atrioventricular block without pacemaker placement, QT interval (QTc) greater than 480 ms after heart rate adjustment according to Fridericia's formula, or known history or symptoms of long QT syndrome];
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Jia Shen TabletJia Shen Tablets contain 4 tablets (0.47 g per tablet), take orally, 2 times a day for 12 weeks | Drug | Treatment Group |
Primary outcome
Pharmacokinetic characteristic evaluation：Maximum observed plasma concentration (Cmax)
Time frame: Day 1,27-30,56,84.
To characterize the multiple dose PK of Jia Shen Tablets and assess the time required to reach steady state, the degree of accumulation and the time dependency of the PK in patients with Coronary Heart Disease Complicating Chronic Heart Failure (Syndrome of Yang Deficiency with Blood Stasis).
Plasma PK analysis: Time to reach peak or maximum observed concentration following drug administration (Tmax)
Time frame: Day 1,27-30,56,84.
To characterize the multiple dose PK of Jia Shen Tablets and assess the time required to reach steady state, the degree of accumulation and the time dependency of the PK in patients with Coronary Heart Disease Complicating Chronic Heart Failure (Syndrome of Yang Deficiency with Blood Stasis).
Plasma PK analysis: Area under curve at steady state (AUCss)
Time frame: Day 1,27-30,56,84.
To characterize the multiple dose PK of Jia Shen Tablets and assess the time required to reach steady state, the degree of accumulation and the time dependency of the PK in patients with Coronary Heart Disease Complicating Chronic Heart Failure (Syndrome of Yang Deficiency with Blood Stasis).
5 secondary outcomes
NT-proBNP
Time frame: Baseline to weeks 4,8 and 12.
6-Minutes-Walking-Test (6MWT)
Time frame: Baseline to weeks 4,8 and 12.
Echocardiogram results
Time frame: Baseline to weeks 12.
NYHA classification
Time frame: Baseline to weeks 4,8 and 12.
AEs
Time frame: From baseline (Day1) till follow-up visit (Up to 12 week).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Jia Shen Tablet in people with Heart Failure, run by Tasly Pharmaceutical Group Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rui Liu (022-86343626, liurui2@tasly.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic characteristic evaluation：Maximum observed plasma concentration (Cmax) (time frame: Day 1,27-30,56,84.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2024.