AzTrials
AzTrials

Chronic Heart FailurePhase 2NCT04515290

A Phase IIa Clinical Trial on TSG-01 in the Treatment of Chronic Heart Failure in Patients With Coronary Heart Disease.

A Phase 2 study testing TSG-01 in people with Chronic Heart Failure, run by Shanghai Hongyitang Biopharmaceutical Technology Co. Ltd. at 5 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to assess the safety, efficacy and optimal dose of TSG-01, an innovative drug with ginsenosides as its main components, in the treatment of patients with chronic heart failure(CHF). Read more about this study

Who is it for?
Ages 40 to 75 years
Conditions the study is for
Chronic Heart Failure
What is being tested?
TSG-01
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
85 participants
Where
5 sitesChina
Study dates
7 May 2020to 22 Apr 2022
Phase
Phase 2
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 40 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age: 40 to 75 years.
  • Have chronic heart failure(CHF) due to ischemic causes and defined as NYHA classification of III.
  • Left ventricular ejection fraction (LVEF) of ≤45% and ≥25% as determined by improved biplane Simpson method
  • NT-proBNP≥450pg/ml
  • Be on a stable regime of standardized therapy for CHF at least 2 weeks prior to receiving study medication and are respected to remain on a stable regime throughout the duration of the trial without the need to receive intravenously vasoactive agents or/and diuretics. Standardized therapy includes ACEI/ARB, beta-blocker, aldosterone receptor antagonist, diuretic, digitalis.
  • Is able to understand the trial and provide informed consent.

Who cannot join

  • Has hypertensive cardiopathy, pulmonary heart disease, congenital heart disease, moderate to severe pulmonary hypertension (pulmonary artery pressure ≥ 40mmHg), moderate to severe cardiac valve stenosis or insufficiency, any type of cardiomyopathy(hypertrophic, restrictive or dilated cardiomyopathy); moderate to severe pericardial effusion, constrictive pericarditis, and heart failure caused by arrhythmia.
  • Has noncardiogenic heart failure caused by diseases in kidney, lung, liver, or by rheumatic immune disorders, severe infection and chemical factors (chemotherapy, alcohol, etc.).
  • Has active tuberculosis or systemic lupus erythematosus (SLE)
  • Had acute myocardial infarction, biventricular pacemaker implantation for cardiac resynchronization, cardiothoracic surgery or was complicated with acute coronary syndrome, pulmonary embolism and acute cerebrovascular disease within 3 months prior to receiving study medication.
  • Had symptomatic ventricular tachycardia or pleomorphic ventricular tachycardia, cardiogenic shock (CGS), a progressive exacerbation of unstable angina, uncontrolled malignant arrhythmia, second degree sinoatrial or AV block Mobitz Type II or above without pacemaker implantation, QTc>550 ms and heart rate <50 bmp. Had uncontrolled hypertension, systolic blood pressure≥180/mmHg and/or diastolic blood pressure≥110mmHg, or hypotension with systolic blood pressure<90mmHg and/or diastolic blood pressure<60mmHg.
  • Had coronary revascularization procedure (percutaneous or surgical) within 12 weeks prior to receiving study medication or be expected to have coronary revascularization or left ventricular remodeling operation in next 12 weeks.
Show all 16Show fewer
  • Has hepatic abnormality defined as ALT≥1.5 times the upper limit of normal, or has impaired renal function with Cr≥1.5 times the upper limit of normal. Has severe anemia (Hb<70g/L), pheochromocytoma, hematopathy, gastrointestinal bleeding (consecutive fecal occult blood tests positive, except bleeding caused by hemorrhoids or other anal diseases).
  • Has a body weight>200kg.
  • The subject has the need for mechanical ventilation, or has a history of a stroke or any malignancy within 4 weeks prior to receiving study medication.
  • Has psychosis with poor control, or is a drug addict who has not been detoxified.
  • Allergic to the study drug.
  • Has participated in any clinical trial involving experimental therapy 3 months prior to screening.
  • If female, being pregnant or lactating, or plan to get pregnant in next 3 months.
  • Has a survival time less than 3 months according to the investigator's judgement.
  • Subject who are taking Entresto (Sacubitril Valsartan Sodium Tablets) medication.
  • Unable to complete the study or comply with the requirements of the study (for management or other reasons) according to the investigator's judgement.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

China5 sites

  • Zhejiang Provincial Hospital of Chinese Medicine

    Hangzhou, Zhejiang, 310006

  • Affiliated Hospital of Nanjing University of Chinese Medicine

    Nanjing, Jiangsu, 210029

  • Shanghai Shuguang Hospital

    Shanghai, Shanghai Municipality, 200021

  • Henan Province Hospital of TCM

    Zhengzhou, Henan, 450000

  • The first Affiliated Hospital of Henan University of CM

    Zhengzhou, Henan, 450000

Other trials in China

About this study

The purpose of this study is to assess the safety, efficacy and optimal dose of TSG-01, an innovative drug with ginsenosides as its main components, in the treatment of patients with chronic heart failure(CHF). Preclinical studies have revealed that TSG-01 promote myocardial energy metabolism and ATP production, reduce the damage of human pulmonary microvascular endothelial cell connection, resist arrhythmia, and regulate the lipid metabolism disorder caused by myocardial ischemia. Results from CHF animal models(dog, rat) showed that TSG-01 significantly increase coronary blood supply, improve myocardial contractility, reduce heart expansion and pulmonary edema. Besides its potency of improving heart function, TSG-01 was found to induce diuresis without obvious effect on urine potassium in rats. TSG-01 has been approved by CFDA for a clinical trial on the treatment of CHF (Approval No. 2018L03012). A randomized, double-blind, multicenter, placebo-controlled phase IIa clinical trial is now being conducted in 5 hospitals in China. A total of 90 cases of CHF caused by coronary heart disease are included and randomly divided into three groups: high-dose, low-dose of TSG-01 and placebo group. NYHA functional class, 6-minute walk test(6MHWT) distance, NT-proBNP, left ventricular ejection fraction(LVEF), echocardiographic parameters (LVESV, LVEDV, and heart size) and MLHFQ score are measured before, during and after treatment to evaluate the benefits of TSG-01 therapy in patients with CHF.

Being tested
TSG-01, TSG-01 and Placebo, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TSG-01Drug

    Two tablets of TSG-01 (0.35g/tablet) were given by oral with 3 times a day for 12 weeks; High dose group.

  • TSG-01 and PlaceboDrug

    One tablet of TSG-01 (0.35g/tablet) and one tablet of placebo (0.35g/tablet) were given by oral with 3 times a day for 12 weeks; Low dose group.

  • PlaceboDrug

    Two tablets of placebo (0.35g/tablet) were given by oral with 3 times a day for 12 weeks.

Study groups in NCT04515290
Study groupRoleWhat they receive
TSG-01-HExperimentalTwo tablets of TSG-01 per time.
Receives: Drug: TSG-01
TSG-01-LExperimentalOne tablet of TSG-01 and One tablet of Placebo per time.
Receives: Drug: TSG-01 and Placebo
ControlPlacebo comparatorTwo tablets of Placebo per time.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. New York Heart Association (NYHA) Classification

    Change from baseline and placebo in NYHA class status. NYHA Classification is a heart function classification which divides impaired cardiac function into four levels according to the action capacity of the patient. And among NYHA classification, Class I represents the mildest symptoms, while Class IV represents the most severe case.

    Measured: 12th week after intervention

  2. Six(6)-minute walk test

    To measure the distance that the patient is instructed to walk along a hallway as far as he(or she) can in 6 minutes.

    Measured: 12th week after intervention

Secondary outcomes (6)

  1. Change of NT-proBNP (N-Terminal Pro-B-Type Natriuretic Peptide) Level from baseline and placebo

    Measured: 12th week after intervention

  2. Change in LVEF from screening/baseline as determined by echocardiography

    Measured: 12th week after intervention

  3. Change in LVESV from screening/baseline as determined by echocardiography

    Measured: 12th week after intervention

  4. Change in LVEDV from screening/baseline as determined by echocardiography

    Measured: 12th week after intervention

  5. Change in cardiac size from screening/baseline as determined by echocardiography

    Measured: 12th week after intervention

  6. Minnesota Living with Heart Failure Questionnaire (MLHFQ)

    Measured: 12th week after intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2020
  2. Study start7 May 2020
  3. Primary completion22 Apr 2022
  4. Study completion22 Apr 2022

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
85 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04515290
Sponsor's protocol ID
HYT-CT-01
Status last verified
Oct 2022
First submitted
13 Aug 2020
Last updated
26 Oct 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TSG-01 in people with Chronic Heart Failure, run by Shanghai Hongyitang Biopharmaceutical Technology Co. Ltd. at 5 sites 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 6 inclusion and 16 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: finished, as of the sponsor's last update on 26 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

New York Heart Association (NYHA) Classification (time frame: 12th week after intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04515290.

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 26 Oct 2022; AzTrials last refreshed its copy on 6 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in