Chronic Heart Failure PatientsEarly Phase 1NCT05924958
Clinical Study on the Immunomodulatory Effect of Eprolidone on Patients With Chronic Heart Failure
A Early Phase 1 study testing Eprolidone in people with Chronic Heart Failure Patients, run by Cheng LuFeng,Principal Investigator.
Trial summary
Chronic heart failure has a high incidence, mortality rate, and disability rate. There are approximately 4 million heart failure patients among adults aged 35-74 in China, which has become a major public health issue. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Heart Failure Patients
- What is being tested?
- Eprolidone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2023to 1 Sep 2026
- Phase
- Early 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sign informed consent form, NYHA Level I, Level II Ш The left ventricular ejection fraction (LVEF) measured by radionuclide ventriculography (RNVG) after diagnosis of chronic congestive heart failure (CHF) is ≤ 45%.
Who cannot join
- Age<18 or>80, serum creatinine level>2.5 mg/deciliter, blood potassium level>5.0 mmol/liter, surgical treatment for valvular heart disease, contraindications to the study drug, use of other aldosterone receptor antagonists, malignant tumors and other life-threatening non cardiac diseases, legally incapacitated patients, history of drug and alcohol abuse, pregnant and postpartum women, and women breastfeeding during the study period. The subjects were divided into a conventional treatment group and an epridone group, with the conventional treatment group taking other conventional anti chronic heart failure drugs other than aldosterone receptor blockers as the baseline. The epridone group received conventional medication combined with 25 mg/day of epridone, gradually increasing to 50 mg/day for 4 consecutive weeks.
About this study
Official title: College of Pharmacy, Xinjiang Medical University
Chronic heart failure has a high incidence, mortality rate, and disability rate. There are approximately 4 million heart failure patients among adults aged 35-74 in China, which has become a major public health issue. In this context, accelerating the development of drugs for treating chronic heart failure has become an urgent and urgent problem to be solved. Therefore, revealing the pathogenic mechanism of chronic heart failure, finding specific drug intervention targets, conducting personalized and precise diagnosis and treatment, reducing the economic burden of patients, and promoting national economic development have significant practical significance and far-reaching strategic impact. Heart failure, as the final stage of various cardiovascular diseases, is difficult to recover once it occurs, so it is of great benefit to achieve "early detection and treatment" for heart failure. At present, biomarkers are mainly used for the diagnosis and prognosis of heart failure, and there are very few biomarkers that provide early warning information. Therefore, it is urgent to find biomarkers that can provide early warning effects. This project focuses on the effect of Eprolidone on the activity of regulatory T cells (Treg), expanding the selection of heart failure treatment drugs, improving drug efficacy, avoiding ineffective treatment, and reducing adverse reactions of the drugs. By carrying out high-quality and precise treatment, we aim to promote the update of the diagnosis and treatment guidelines for chronic heart failure, and provide treatment plans for the prevention and treatment of chronic heart failure and the formulation and adjustment of national medical and health policies.
Read the detailed description
Recruit participants subjects and sign a written informed consent form. Randomly divide the participants into a conventional treatment group and an epridone group. The conventional treatment group received other conventional anti chronic heart failure drugs that were not aldosterone receptor blockers, and the baseline was taken. The epridone group received conventional medication combined with 25 mg/day of epridone, gradually increasing to 50 mg/day for 4 consecutive weeks.The participants' venous blood was drawn once a week to test the participants' cardiac function and related immunological indicators.Regularly follow up participants to compare adverse reactions and clinical endpoints.
- Conditions
- Chronic Heart Failure Patients
- Being tested
- Eprolidone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EprolidoneDrug
This study assessed the effect of eplerenone on circulating Treg cells in patients with chronic heart failure by detecting the level of aldosterone in venous blood and the activity of Treg cells and the level of inflammatory factors related to it after taking drugs.
| Study group | Role | What they receive |
|---|---|---|
| Eprolidone intervention in patients with chronic heart failure | Experimental | The Pulidone group received conventional medication combined with 25 mg/day of Eprolidone, gradually increasing to 50 mg/day for 4 consecutive weeks Receives: Drug: Eprolidone |
| Patients in the conventional treatment group | No intervention | Other conventional anti chronic heart failure drugs for the conventional treatment group taking non aldosterone receptor blockers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expression of Kv1.3 channel protein in Treg cells in circulating blood
Detection of Treg cell activity in venous blood of patients
Measured: 4 weeks
Levels of aldosterone in blood circulation （pg/mL)
Detection of aldosterone in venous blood of patients by ELISA
Measured: 4 weeks
The levels of IL-10 and TGF-β in blood circulation （pg/mL)
Detection of plasma inflammatory factors in subjects
Measured: 4 weeks
Secondary outcomes (1)
Detection of left ventricular Ejection fraction by echocardiography
Echocardiographic detection of cardiac function in patients
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2023
- Study start1 Sep 2023 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Heart Failure PatientsStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Conventional treatment group Eprolidone group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cheng LuFeng,Principal Investigator
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital of Xinjiang Medical University
- Responsible party
- Sponsor-investigator, Cheng LuFeng,Principal Investigator, Xinjiang Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05924958
- Sponsor's protocol ID
- LFCheng
- Status last verified
- Jun 2023
- First submitted
- 6 Jun 2023
- Last updated
- 29 Jun 2023
- 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 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- College of Pharmacy, Xinjiang Medical University
- ClinicalTrials.gov ID
- NCT05924958
- Acronym / sponsor ID
- LFCheng
- Conditions
- Chronic Heart Failure Patients
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Cheng LuFeng,Principal InvestigatorUniversity, hospital or other
- Collaborators
- First Affiliated Hospital of Xinjiang Medical University
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 29 Jun 2023 (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.
Chronic heart failure has a high incidence, mortality rate, and disability rate. There are approximately 4 million heart failure patients among adults aged 35-74 in China, which has become a major public health issue. In this context, accelerating the development of drugs for treating chronic heart failure has become an urgent and urgent problem to be solved. Therefore, revealing the pathogenic mechanism of chronic heart failure, finding specific drug intervention targets, conducting personalized and precise diagnosis and treatment, reducing the economic burden of patients, and promoting national economic development have significant practical significance and far-reaching strategic impact. Heart failure, as the final stage of various cardiovascular diseases, is difficult to recover once it occurs, so it is of great benefit to achieve "early detection and treatment" for heart failure. At present, biomarkers are mainly used for the diagnosis and prognosis of heart failure, and there are very few biomarkers that provide early warning information. Therefore, it is urgent to find biomarkers that can provide early warning effects. This project focuses on the effect of Eprolidone on the activity of regulatory T cells (Treg), expanding the selection of heart failure treatment drugs, improving drug efficacy, avoiding ineffective treatment, and reducing adverse reactions of the drugs. By carrying out high-quality and precise treatment, we aim to promote the update of the diagnosis and treatment guidelines for chronic heart failure, and provide treatment plans for the prevention and treatment of chronic heart failure and the formulation and adjustment of national medical and health policies.
Detailed description
Recruit participants subjects and sign a written informed consent form. Randomly divide the participants into a conventional treatment group and an epridone group. The conventional treatment group received other conventional anti chronic heart failure drugs that were not aldosterone receptor blockers, and the baseline was taken. The epridone group received conventional medication combined with 25 mg/day of epridone, gradually increasing to 50 mg/day for 4 consecutive weeks.The participants' venous blood was drawn once a week to test the participants' cardiac function and related immunological indicators.Regularly follow up participants to compare adverse reactions and clinical endpoints.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Conventional treatment group Eprolidone group
| Arm | Type | Receives |
|---|---|---|
| Eprolidone intervention in patients with chronic heart failure | Experimental | Drug: EprolidoneThe Pulidone group received conventional medication combined with 25 mg/day of Eprolidone, gradually increasing to 50 mg/day for 4 consecutive weeks |
| Patients in the conventional treatment group | No intervention | –Other conventional anti chronic heart failure drugs for the conventional treatment group taking non aldosterone receptor blockers |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Sign informed consent form, NYHA Level I, Level II Ш The left ventricular ejection fraction (LVEF) measured by radionuclide ventriculography (RNVG) after diagnosis of chronic congestive heart failure (CHF) is ≤ 45%.
Key exclusion criteria (1 listed)
- Age<18 or>80, serum creatinine level>2.5 mg/deciliter, blood potassium level>5.0 mmol/liter, surgical treatment for valvular heart disease, contraindications to the study drug, use of other aldosterone receptor antagonists, malignant tumors and other life-threatening non cardiac diseases, legally incapacitated patients, history of drug and alcohol abuse, pregnant and postpartum women, and women breastfeeding during the study period. The subjects were divided into a conventional treatment group and an epridone group, with the conventional treatment group taking other conventional anti chronic heart failure drugs other than aldosterone receptor blockers as the baseline. The epridone group received conventional medication combined with 25 mg/day of epridone, gradually increasing to 50 mg/day for 4 consecutive weeks.
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 |
|---|---|---|
| EprolidoneThis study assessed the effect of eplerenone on circulating Treg cells in patients with chronic heart failure by detecting the level of aldosterone in venous blood and the activity of Treg cells and the level of inflammatory factors related to it after taking drugs. | Drug | Eprolidone intervention in patients with chronic heart failure |
Primary outcome
Expression of Kv1.3 channel protein in Treg cells in circulating blood
Time frame: 4 weeks
Detection of Treg cell activity in venous blood of patients
Levels of aldosterone in blood circulation （pg/mL)
Time frame: 4 weeks
Detection of aldosterone in venous blood of patients by ELISA
The levels of IL-10 and TGF-β in blood circulation （pg/mL)
Time frame: 4 weeks
Detection of plasma inflammatory factors in subjects
1 secondary outcome
Detection of left ventricular Ejection fraction by echocardiography
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Eprolidone in people with Chronic Heart Failure Patients, run by Cheng LuFeng,Principal Investigator.
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 1 inclusion and 1 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 29 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
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?
Expression of Kv1.3 channel protein in Treg cells in circulating blood (time frame: 4 weeks). 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 29 Jun 2023.