Heart Failure, Diastolic (HFpEF)NCT06629246

Pogejiuxin Decoction Combination of Conventional Western Medicine for the Treatment of Heart Failure With Preserved Ejection Fraction

A study testing Conventional heart failure treatment and Pogejiuxin decoction combined with conventional heart failure treatment in people with Heart Failure, Diastolic (HFpEF), run by Chongqing Traditional Chinese Medicine Hospital at 1 site in China.

Completed

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

Official record

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Trial summary

The objective of this study is to investigate the potential of Pogejiuxin Decoction to enhance the efficacy and mitigate the adverse effects associated with conventional treatment in patients with heart failure and preserved ejection fraction(HFpEF), thereby establishing a foundation for its clinical application in… Read more about this study

Who is it for?: Any age
Conditions the study is for: Heart Failure, Diastolic (HFpEF)
What is being tested?: Conventional heart failure treatment and Pogejiuxin decoction combined with conventional heart failure treatment
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 1 siteChina
Study dates: 1 Sep 2021to 17 Sep 2023
Phase: Interventional
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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Inpatients with heart failure who meet the diagnostic criteria of China Guidelines for the Diagnosis and Treatment of Heart Failure 2018 and have grade II-IV heart function;
Inpatients who meet the diagnostic criteria for heart failure in TCM Internal Medicine(2012 edition);
Patients who meet the diagnostic criteria for HfpEF by heart color ultrasound;
Patients who sign informed consent and take the test voluntarily.

Who cannot join

Patients who do not meet the inclusion criteria.
Patients with severe hepatic or renal impairment (ALT/AST \> 3 times the upper limit or serum creatinine levels \> 265 umol/L or serum potassium \> 5.5 mmol/L).
Patients with severe cerebrovascular, hematological, neurological diseases, or malignant tumors that require special treatment during the study period and may affect the judgment of heart failure treatment efficacy.
Patients with severe pneumonia, serious infections, or acute exacerbation of chronic obstructive pulmonary disease.
Pregnant or nursing women.
Patients with psychiatric abnormalities or unwilling to cooperate.
Patients allergic to the components of Pogejiuxin Decoction.
Patients undergoing coronary intervention, cardiac pacemaker implantation, placement of cardiac assist devices, or other treatments during the trial period.

Trial locations and contacts

1 site in 1 country.

China1 site

Chongqing Traditional Chinese Medicine Hospital
Chongqing, Chongqing Municipality, 400000

Other trials in China

About this study

Official title: A Randomized Controlled Trial to Evaluate the Efficacy and Safety of Pogejiuxin Decoction Combination of Conventional Treatment for Heart Failure With Preserved Ejection Fraction(HFpEF)

Read the detailed description

This study recruits patients with heart failure and preserved ejection fraction(HFpEF), randomly assigning them to either the intervention group or the control group. The control group will receive the standard heart failure treatment protocol, while the intervention group will take Pogejiuxin Decoction orally in addition to the control group\&#39;s treatment. The study will compare the degree of symptom improvement, relevant auxiliary examination indicators, traditional Chinese medicine syndrome scores, and adverse reaction differences between the two groups, providing a clinical basis for the further enhancement of HFpEF treatment with the combination of Pogejiuxin Decoction and conventional therapy.

Conditions: Heart Failure, Diastolic (HFpEF)
Being tested: Conventional heart failure treatment, Pogejiuxin decoction combined with conventional heart failure treatment
Keywords: Pogejiuxin Decoction, heart failure with preserved ejection fraction
Medical subject headings: Heart Failure, Heart Murmurs

What participants receive

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

Conventional heart failure treatmentDrug
Conventional heart failure treatment, which may include pharmacological therapies such as diuretics, ACE inhibitors/ARBs, beta-blockers, or aldosterone receptor antagonists, based on the clinical requirements of the condition.
Pogejiuxin decoction combined with conventional heart failure treatmentDrug
In addition to receiving standard heart failure treatment, patients are also administered Pogejiuxin Decoction.The formula of Pogejiuxin Decoction is as follows : Processed Aconite 60g (decocted initially for 1 hour), Dried Ginger 60g, Honey-fried Licorice 60g, Cornus officinalis 60g, Ginseng 30g (decocted separately), Raw Dragon Bone 30g (decocted initially for 1 hour), Raw Oyster Shell 30g (decocted initially for 1 hour), Living Magnetite 30g, for a total of 7 prescriptions. Usage: Uniformly decocted with a herbal medicine decoction machine to obtain the medicinal liquid, one prescription per day, taken twice daily in the morning and evening, each time 100ml, for a continuous treatment of 7 days.

Study groups in NCT06629246
Study group	Role	What they receive
control group	Active comparator	The control group will receive conventional heart failure treatment, which may include pharmacological therapies such as diuretics, ACE inhibitors/ARBs, beta-blockers, or aldosterone receptor antagonists, based on the clinical requirements of the condition, for a treatment period of 7 days. Receives: Drug: Conventional heart failure treatment
intervention group	Active comparator	The intervention group will receive Pogejiuxin Decoction orally, in addition to the treatment protocol given to the control group.The specific medicinal formula is as follows: Processed Aconite 60g (decocted initially for 1 hour), Dried Ginger 60g, Honey-fried Licorice 60g, Cornus officinalis 60g, Ginseng 30g (decocted separately), Raw Dragon Bone 30g (decocted initially for 1 hour), Raw Oyster Shell 30g (decocted initially for 1 hour), Living Magnetite 30g, for a total of 7 prescriptions. Usage: Uniformly decocted with a herbal medicine decoction machine to obtain the medicinal liquid, one prescription per day, taken twice daily in the morning and evening, each time 100ml, for a continuous treatment of 7 days. Receives: Drug: Pogejiuxin decoction combined with conventional heart failure treatment

What is being measured

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

NT-proBNP
NT-proBNP, secreted by cardiac muscle cells, serves as a biomarker that reflects cardiac function. Under normal conditions, the body contains a small amount of NT-proBNP. However, in cases of heart failure, the levels of NT-proBNP increase, making it one of the indicators for diagnosing heart failure and assessing the effectiveness of heart failure treatment. The specific diagnostic criteria are as follows:
For patients under 50 years of age: over 450 ng/L; For patients aged from 50 to 75: over 900 ng/L; For patients over 75 years of age: over 1800 ng/L; For patients with impaired renal function (glomerular filtration rate over 60 mL/min): over 1200 ng/L.
Measured: From enrollment to the end of treatment at 7 days
Echocardiography(LVEF, LVEDD and LVESD)
Echocardiography is used to assess cardiac function. LVEF Left ventricular ejection fraction (LVEF) is the most commonly used indicator to evaluate left ventricular systolic function in clinical practice. LVEF is calculated from the measurements of end-diastolic volume (EDV) and end-systolic volume (ESV), using the following formula:LVEF = (EDV - ESV) / EDV × 100%. An LVEF of less than 52% in males and less than 53% in females suggests abnormal left ventricular systolic function. An LVEF between 40% and 52% indicates mildly reduced left ventricular systolic function, 30% to 40% indicates moderately reduced function, and less than 30% indicates severely reduced function.
LVEDD and LVESD In males, a left ventricular end-diastolic diameter (LVEDD) over 55 mm and in females over 50 mm, and a left ventricular end-systolic diameter (LVESD) over 37 mm in males and over 35 mm in females, suggest left ventricular dilation and impaired left ventricular function.
Measured: From enrollment to the end of treatment at 7 days
hs-CRP
High-sensitivity C-reactive protein (hs-CRP) is one of the most potent predictors of cardiovascular risk events, with the following clinical implications:
A level of under 1 mg/L indicates low risk; A level of 1-3 mg/L indicates moderate risk; A level above 3 mg/L indicates high risk.
Measured: From enrollment to the end of treatment at 7 days
Inflammatory Factors(TNF-α, IL-6, and IL-8)
Clinical practice has confirmed that levels of inflammatory cytokines such as TNF-α, IL-6, and IL-8 are elevated in patients with heart failure compared to the general population. These inflammatory factors can further exacerbate myocardial damage and participate in the process of ventricular remodeling. Therefore, monitoring TNF-α, IL-6, and IL-8 can be used to assess the condition of patients with heart failure. Elevated levels of TNF-α over 5 ng/L (bioactivity assay), IL-6 over 10 ng/L, and IL-8 over 21.3 μg/L (ELISA method) suggest the presence of inflammation in the body.
Measured: From enrollment to the end of treatment at 7 days
Minnesota Living with Heart Failure Questionnaire (MLHFQ)
The Minnesota Living with Heart Failure Questionnaire (MLHFQ) is a widely used instrument for assessing health-related quality of life in patients with heart failure (HF). It evaluates quality life of patients across three domains: physical, emotional, and other. The questionnaire consists of 21 items, with responses rated on a scale from zero to five, indicating none (0 points), very little (1 point), a little (2 points), moderate (3 points), quite a bit (4 points), and severe (5 points). The scores of all items are summed up, with higher scores indicating poorer quality of life.
Measured: From enrollment to the end of treatment at 7 days

Secondary outcomes (1)

Traditional Chinese Medicine (TCM) Symptom Score
According to the Guiding Principles for Clinical Research of New Drugs in Traditional Chinese Medicine. The Traditional Chinese Medicine (TCM) symptoms are categorized into primary and secondary symptoms and are scored based on their severity. Primary symptoms include palpitations, fatigue, dyspnea, and lower limb edema, each rated on a scale of four levels: none (0 points), mild (2 points), moderate (4 points), and severe (6 points). Secondary symptoms include lethargy, abdominal distension, oliguria, spontaneous sweating, and dull complexion/cyanosis of lips and nails, each rated on a scale of four levels: none (0 points), mild (1 point), moderate (2 points), and severe (3 points). The total score from all items represents the TCM symptom score.The higher the score, the more severe the symptoms.
Measured: From enrollment to the end of treatment at 7 days

Timeline

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

1 Sep 202117 Sep 2023

First posted8 Oct 2024
Study start1 Sep 2021
Primary completion20 Aug 2023
Study completion17 Sep 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Heart Failure, Diastolic (HFpEF)Studies 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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06629246
Sponsor's protocol ID: 2021-ky-17
Status last verified: Sep 2024
First submitted: 23 Sep 2024
Last updated: 8 Oct 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes

Publications

Liu L, Mo Y, Wu B, Yu Z, Sun B. Effect of Traditional Chinese Medicine Poge Heart-Saving Decoction on Cardiac Function in Heart Failure Rat Model. Evid Based Complement Alternat Med. 2020 Dec 3;2020:8762509. doi: 10.1155/2020/8762509. eCollection 2020.
PubMed 33628294
Li X, Zhang J, Huang J, Ma A, Yang J, Li W, Wu Z, Yao C, Zhang Y, Yao W, Zhang B, Gao R; Efficacy and Safety of Qili Qiangxin Capsules for Chronic Heart Failure Study Group. A multicenter, randomized, double-blind, parallel-group, placebo-controlled study of the effects of qili qiangxin capsules in patients with chronic heart failure. J Am Coll Cardiol. 2013 Sep 17;62(12):1065-1072. doi: 10.1016/j.jacc.2013.05.035. Epub 2013 Jun 7.
PubMed 23747768
Solomon SD, McMurray JJV, Anand IS, Ge J, Lam CSP, Maggioni AP, Martinez F, Packer M, Pfeffer MA, Pieske B, Redfield MM, Rouleau JL, van Veldhuisen DJ, Zannad F, Zile MR, Desai AS, Claggett B, Jhund PS, Boytsov SA, Comin-Colet J, Cleland J, Dungen HD, Goncalvesova E, Katova T, Kerr Saraiva JF, Lelonek M, Merkely B, Senni M, Shah SJ, Zhou J, Rizkala AR, Gong J, Shi VC, Lefkowitz MP; PARAGON-HF Investigators and Committees. Angiotensin-Neprilysin Inhibition in Heart Failure with Preserved Ejection Fraction. N Engl J Med. 2019 Oct 24;381(17):1609-1620. doi: 10.1056/NEJMoa1908655. Epub 2019 Sep 1.
PubMed 31475794

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 2
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RecruitingPhase 1
A Study of LY3971297 in Participants With Heart Failure
Heart Failure, Heart Failure, Diastolic
Recruiting
PrEcision Pacing in HFpEF: the PEP-HFpEF Trial
Heart Failure and Preserved Ejection Fraction, Heart Failure New York Heart Association Class III
Recruiting
Assessment of CCM in HF With Higher Ejection Fraction
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Not yet recruiting
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All Heart Failure, Diastolic (HFpEF) trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Controlled Trial to Evaluate the Efficacy and Safety of Pogejiuxin Decoction Combination of Conventional Treatment for Heart Failure With Preserved Ejection Fraction(HFpEF)
ClinicalTrials.gov ID: NCT06629246
Acronym / sponsor ID: 2021-ky-17
Conditions: Heart Failure, Diastolic (HFpEF)
Keywords: Pogejiuxin Decoction, heart failure with preserved ejection fraction
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Chongqing Traditional Chinese Medicine HospitalUniversity, hospital or other
Collaborators: Chongqing Science and Technology Commission, Chongqing Health and Family Planning Commission
Study start: 1 Sep 2021 (actual)
Primary completion: 20 Aug 2023 (actual)
Study completion: 17 Sep 2023 (actual)
First posted: 8 Oct 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
control group	Active comparator	Drug: Conventional heart failure treatmentThe control group will receive conventional heart failure treatment, which may include pharmacological therapies such as diuretics, ACE inhibitors/ARBs, beta-blockers, or aldosterone receptor antagonists, based on the clinical requirements of the condition, for a treatment period of 7 days.
intervention group	Active comparator	Drug: Pogejiuxin decoction combined with conventional heart failure treatmentThe intervention group will receive Pogejiuxin Decoction orally, in addition to the treatment protocol given to the control group.The specific medicinal formula is as follows: Processed Aconite 60g (decocted initially for 1 hour), Dried Ginger 60g, Honey-fried Licorice 60g, Cornus officinalis 60g, Ginseng 30g (decocted separately), Raw Dragon Bone 30g (decocted initially for 1 hour), Raw Oyster Shell 30g (decocted initially for 1 hour), Living Magnetite 30g, for a total of 7 prescriptions. Usage: Uniformly decocted with a herbal medicine decoction machine to obtain the medicinal liquid, one prescription per day, taken twice daily in the morning and evening, each time 100ml, for a continuous treatment of 7 days.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (4 listed)

Inpatients with heart failure who meet the diagnostic criteria of China Guidelines for the Diagnosis and Treatment of Heart Failure 2018 and have grade II-IV heart function;
Inpatients who meet the diagnostic criteria for heart failure in TCM Internal Medicine(2012 edition);
Patients who meet the diagnostic criteria for HfpEF by heart color ultrasound;
Patients who sign informed consent and take the test voluntarily.

Key exclusion criteria (8 listed)

Patients who do not meet the inclusion criteria.
Patients with severe hepatic or renal impairment (ALT/AST \> 3 times the upper limit or serum creatinine levels \> 265 umol/L or serum potassium \> 5.5 mmol/L).
Patients with severe cerebrovascular, hematological, neurological diseases, or malignant tumors that require special treatment during the study period and may affect the judgment of heart failure treatment efficacy.
Patients with severe pneumonia, serious infections, or acute exacerbation of chronic obstructive pulmonary disease.
Pregnant or nursing women.

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
Conventional heart failure treatmentConventional heart failure treatment, which may include pharmacological therapies such as diuretics, ACE inhibitors/ARBs, beta-blockers, or aldosterone receptor antagonists, based on the clinical requirements of the condition.	Drug	control group
Pogejiuxin decoction combined with conventional heart failure treatmentIn addition to receiving standard heart failure treatment, patients are also administered Pogejiuxin Decoction.The formula of Pogejiuxin Decoction is as follows : Processed Aconite 60g (decocted initially for 1 hour), Dried Ginger 60g, Honey-fried Licorice 60g, Cornus officinalis 60g, Ginseng 30g (decocted separately), Raw Dragon Bone 30g (decocted initially for 1 hour), Raw Oyster Shell 30g (decocted initially for 1 hour), Living Magnetite 30g, for a total of 7 prescriptions. Usage: Uniformly decocted with a herbal medicine decoction machine to obtain the medicinal liquid, one prescription per day, taken twice daily in the morning and evening, each time 100ml, for a continuous treatment of 7 days.	Drug	intervention group

Primary outcome

NT-proBNP
Time frame: From enrollment to the end of treatment at 7 days
NT-proBNP, secreted by cardiac muscle cells, serves as a biomarker that reflects cardiac function. Under normal conditions, the body contains a small amount of NT-proBNP. However, in cases of heart failure, the levels of NT-proBNP increase, making it one of the indicators for diagnosing heart failure and assessing the effectiveness of heart failure treatment. The specific diagnostic criteria are as follows: For patients under 50 years of age: over 450 ng/L; For patients aged from 50 to 75: over 900 ng/L; For patients over 75 years of age: over 1800 ng/L; For patients with impaired renal function (glomerular filtration rate over 60 mL/min): over 1200 ng/L.
Echocardiography(LVEF, LVEDD and LVESD)
Time frame: From enrollment to the end of treatment at 7 days
Echocardiography is used to assess cardiac function. LVEF Left ventricular ejection fraction (LVEF) is the most commonly used indicator to evaluate left ventricular systolic function in clinical practice. LVEF is calculated from the measurements of end-diastolic volume (EDV) and end-systolic volume (ESV), using the following formula:LVEF = (EDV - ESV) / EDV × 100%. An LVEF of less than 52% in males and less than 53% in females suggests abnormal left ventricular systolic function. An LVEF between 40% and 52% indicates mildly reduced left ventricular systolic function, 30% to 40% indicates moderately reduced function, and less than 30% indicates severely reduced function. LVEDD and LVESD In males, a left ventricular end-diastolic diameter (LVEDD) over 55 mm and in females over 50 mm, and a left ventricular end-systolic diameter (LVESD) over 37 mm in males and over 35 mm in females, suggest left ventricular dilation and impaired left ventricular function.
hs-CRP
Time frame: From enrollment to the end of treatment at 7 days
High-sensitivity C-reactive protein (hs-CRP) is one of the most potent predictors of cardiovascular risk events, with the following clinical implications: A level of under 1 mg/L indicates low risk; A level of 1-3 mg/L indicates moderate risk; A level above 3 mg/L indicates high risk.
Inflammatory Factors(TNF-α, IL-6, and IL-8)
Time frame: From enrollment to the end of treatment at 7 days
Clinical practice has confirmed that levels of inflammatory cytokines such as TNF-α, IL-6, and IL-8 are elevated in patients with heart failure compared to the general population. These inflammatory factors can further exacerbate myocardial damage and participate in the process of ventricular remodeling. Therefore, monitoring TNF-α, IL-6, and IL-8 can be used to assess the condition of patients with heart failure. Elevated levels of TNF-α over 5 ng/L (bioactivity assay), IL-6 over 10 ng/L, and IL-8 over 21.3 μg/L (ELISA method) suggest the presence of inflammation in the body.
Minnesota Living with Heart Failure Questionnaire (MLHFQ)
Time frame: From enrollment to the end of treatment at 7 days
The Minnesota Living with Heart Failure Questionnaire (MLHFQ) is a widely used instrument for assessing health-related quality of life in patients with heart failure (HF). It evaluates quality life of patients across three domains: physical, emotional, and other. The questionnaire consists of 21 items, with responses rated on a scale from zero to five, indicating none (0 points), very little (1 point), a little (2 points), moderate (3 points), quite a bit (4 points), and severe (5 points). The scores of all items are summed up, with higher scores indicating poorer quality of life.

1 secondary outcome

Traditional Chinese Medicine (TCM) Symptom Score
Time frame: From enrollment to the end of treatment at 7 days

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
Results publication: PubMed 33628294Liu L, Mo Y, Wu B, Yu Z, Sun B. Effect of Traditional Chinese Medicine Poge Heart-Saving Decoction on Cardiac Function in Heart Failure Rat Model. Evid Based Complement Alternat Med. 2020 Dec 3;2020:8762509. doi: 10.1155/2020/8762509. eCollection 2020.
Results publication: PubMed 23747768Li X, Zhang J, Huang J, Ma A, Yang J, Li W, Wu Z, Yao C, Zhang Y, Yao W, Zhang B, Gao R; Efficacy and Safety of Qili Qiangxin Capsules for Chronic Heart Failure Study Group. A multicenter, randomized, double-blind, parallel-group, placebo-controlled study of the effects of qili qiangxin capsules in patients with chronic heart failure. J Am Coll Cardiol. 2013 Sep 17;62(12):1065-1072. doi: 10.1016/j.jacc.2013.05.035. Epub 2013 Jun 7.
Results publication: PubMed 31475794Solomon SD, McMurray JJV, Anand IS, Ge J, Lam CSP, Maggioni AP, Martinez F, Packer M, Pfeffer MA, Pieske B, Redfield MM, Rouleau JL, van Veldhuisen DJ, Zannad F, Zile MR, Desai AS, Claggett B, Jhund PS, Boytsov SA, Comin-Colet J, Cleland J, Dungen HD, Goncalvesova E, Katova T, Kerr Saraiva JF, Lelonek M, Merkely B, Senni M, Shah SJ, Zhou J, Rizkala AR, Gong J, Shi VC, Lefkowitz MP; PARAGON-HF Investigators and Committees. Angiotensin-Neprilysin Inhibition in Heart Failure with Preserved Ejection Fraction. N Engl J Med. 2019 Oct 24;381(17):1609-1620. doi: 10.1056/NEJMoa1908655. Epub 2019 Sep 1.
Individual participant dataSharing planned: Yes

Related trials for Heart Failure, Diastolic (HFpEF)

Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
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RecruitingPhase 1
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Recruiting
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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.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 inclusion and 8 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 8 Oct 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.

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?

NT-proBNP (time frame: From enrollment to the end of treatment at 7 days). The study lists 5 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 NCT06629246, which also lists 3 linked publications.

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 8 Oct 2024.