Heart FailureNCT05008679
The Effects of Neuraminidase Inhibitor Oseltamivir in Patients With Chronic Heart Failure
A study testing Oseltamivir in people with Heart Failure, run by Tongji Hospital at 1 site in China.
Trial summary
Heart failure (HF) is a complex syndrome with increasing incidence and high rates of mortality and hospitalization. Although inhibitors of angiotensin converting enzyme (ACE), β-blockers and aldosterone-receptor blockers have improved the treatment of heart failure, mortality of HF remains unacceptably high. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Oseltamivir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 388 participants
- Where
- 1 siteChina
- Study dates
- 25 Feb 2021to 25 Jan 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 of age or older, regardless of gender;
- Patients with NYHA II-IV, LVEF less than 40%;
- Levels of NT-proBNP more than 450 pg/ml
- Willing to participate in this study and sign an informed consent, and receive follow-up contact for at least 6 months.
Who cannot join
- Onset of acute myocardial infarction within the last 1 month;
- Had cardiac surgery or onset of cerebrovascular accident within the last 6 months;
- Plan to have cardiac transplantation or CRT, or already having CRT therapy;
- Females with pregnancy or plan to have pregnancy;
- Have participate in any other clinical trial within the last 3 months;
- Severe neurological disorders (Alzheimer's disease, progressive stage of Parkinson's syndrome), disabilities of lower limbs or deaf-mute;
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- had a history of tumour, or precancerous lesions confirmed by pathological tests (ductal carcinoma in situ, cervical dysplasia, etc.);
- had malignant tumours (by physical examinations, X-ray, type-B ultrasonic imaging or other methods), or had hyperplastic glands or adenoma which possess endocrine activity and affect cardiac or endocrine functions (pheochromocytoma, goitre, etc.);
- The subjects who refuse to comply with the items of the research protocol;
- The subjects who are not available to fulfil the follow-up plan (due to project management or other reasons), according to the judgement of researchers.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital
Wuhan, Hubei, 430030
Li Ni, PHD, +862783662479, nili@tjh.tjmu.edu.cn
About this study
Official title: The Effects of Neuraminidase Inhibitor Oseltamivir in Patients With Chronic Heart Failure: an Open Label, Randomized, Blank-controlled Study.
Heart failure (HF) is a complex syndrome with increasing incidence and high rates of mortality and hospitalization. Although inhibitors of angiotensin converting enzyme (ACE), β-blockers and aldosterone-receptor blockers have improved the treatment of heart failure, mortality of HF remains unacceptably high.
Recently, we identified a key metabolite N-acetylneuraminic acid (Neu5Ac) increased in the plasma of patients with heart failure. Also, elevated plasma Neu5Ac, independent of other traditional risk factors, is associated with poor prognosis in patients with HF in long-term follow up. Neu5Ac levels, the most common sialic acid in mammals, generated from sialylated glycoconjugates by neuraminidase. Neu5Ac and its regulatory enzyme neuraminidase play a key role in heart failure. We found neuraminidase inhibitor could reduce Neu5Ac levels and improve heart failure in mice model, providing opportunity for a novel therapeutic strategy in HF. Neuraminidase inhibitor oseltamivir is also an old anti-influenza drug. Using oseltamivir may be a new therapeutic strategy in heart failure.
Based on above information, we designed the randomized, open-label, blank-controlled study in patients with chronic HF to receive either oseltamivir or placebo, in addition to standard HF therapy to Identify the effect of oseltamivir on serum Neu5Ac level in patients with heart failure and assess the clinic outcomes of level in patients with heart failure using oseltamivir.
- Conditions
- Heart Failure
- Being tested
- Oseltamivir
- Keywords
- heart failure, Neuraminidase inhibitor, oseltamivir, Neu5Ac, NTproBNP
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OseltamivirDrug
Also called Neuraminidase Inhibitor
at a dose of 75 mg twice daily
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | patients with heart failure to receive standard HF therapy |
| Oseltamivir | Experimental | patients with heart failure to receive oseltamivir (at a dose of 75 mg twice daily) for 1 month in addition to standard HF therapy Receives: Drug: Oseltamivir |
What is being measured
The primary outcome is the main question the study is designed to answer.
NT-proBNP
Reduction of NT-proBNP level at 1 month treatment of Oseltamivir
Measured: 1 month
Secondary outcomes (4)
EF (ejection fraction)
Cardiac systolic function assessed by ejection fraction using echocardiography
Measured: 1month, 6 months
NYHA Classification
NYHA Classification after treatment of Oseltamivir
Measured: 1month, 6 months
Quality of life assessment
Minnesota Heart Failure Quality of life assessment after treatment of Oseltamivir
Measured: 1month, 6 months
6-minute walk test
6-minute walk test after treatment of Oseltamivir
Measured: 1month, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2021
- Study start25 Feb 2021
- Primary completion25 Feb 2023 (estimated)
- Study completion25 Jan 2024 (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.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 388 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dao Wen Wang, Tongji Hospital
- Investigators
- Dao Wen Wang, Phd, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05008679
- Sponsor's protocol ID
- TJ-HF-NI
- Status last verified
- Aug 2021
- First submitted
- 14 Aug 2021
- Last updated
- 17 Aug 2021
- 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 17 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Neuraminidase Inhibitor Oseltamivir in Patients With Chronic Heart Failure: an Open Label, Randomized, Blank-controlled Study.
- ClinicalTrials.gov ID
- NCT05008679
- Acronym / sponsor ID
- TJ-HF-NI
- Conditions
- Heart Failure
- Keywords
- heart failure, Neuraminidase inhibitor, oseltamivir, Neu5Ac, NTproBNP
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 388 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 25 Feb 2021 (actual)
- Primary completion
- 25 Feb 2023 (estimated)
- Study completion
- 25 Jan 2024 (estimated)
- First posted
- 17 Aug 2021 (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.
Heart failure (HF) is a complex syndrome with increasing incidence and high rates of mortality and hospitalization. Although inhibitors of angiotensin converting enzyme (ACE), β-blockers and aldosterone-receptor blockers have improved the treatment of heart failure, mortality of HF remains unacceptably high.
Recently, we identified a key metabolite N-acetylneuraminic acid (Neu5Ac) increased in the plasma of patients with heart failure. Also, elevated plasma Neu5Ac, independent of other traditional risk factors, is associated with poor prognosis in patients with HF in long-term follow up. Neu5Ac levels, the most common sialic acid in mammals, generated from sialylated glycoconjugates by neuraminidase. Neu5Ac and its regulatory enzyme neuraminidase play a key role in heart failure. We found neuraminidase inhibitor could reduce Neu5Ac levels and improve heart failure in mice model, providing opportunity for a novel therapeutic strategy in HF. Neuraminidase inhibitor oseltamivir is also an old anti-influenza drug. Using oseltamivir may be a new therapeutic strategy in heart failure.
Based on above information, we designed the randomized, open-label, blank-controlled study in patients with chronic HF to receive either oseltamivir or placebo, in addition to standard HF therapy to Identify the effect of oseltamivir on serum Neu5Ac level in patients with heart failure and assess the clinic outcomes of level in patients with heart failure using oseltamivir.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –patients with heart failure to receive standard HF therapy |
| Oseltamivir | Experimental | Drug: Oseltamivirpatients with heart failure to receive oseltamivir (at a dose of 75 mg twice daily) for 1 month in addition to standard HF therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 of age or older, regardless of gender;
- Patients with NYHA II-IV, LVEF less than 40%;
- Levels of NT-proBNP more than 450 pg/ml
- Willing to participate in this study and sign an informed consent, and receive follow-up contact for at least 6 months.
Key exclusion criteria (10 listed)
- Onset of acute myocardial infarction within the last 1 month;
- Had cardiac surgery or onset of cerebrovascular accident within the last 6 months;
- Plan to have cardiac transplantation or CRT, or already having CRT therapy;
- Females with pregnancy or plan to have pregnancy;
- Have participate in any other clinical trial within the last 3 months;
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 |
|---|---|---|
| OseltamivirAlso: Neuraminidase Inhibitorat a dose of 75 mg twice daily | Drug | Oseltamivir |
Primary outcome
NT-proBNP
Time frame: 1 month
Reduction of NT-proBNP level at 1 month treatment of Oseltamivir
4 secondary outcomes
EF (ejection fraction)
Time frame: 1month, 6 months
NYHA Classification
Time frame: 1month, 6 months
Quality of life assessment
Time frame: 1month, 6 months
6-minute walk test
Time frame: 1month, 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2021.
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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.
Dao Wen Wang, Phd principal investigator
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oseltamivir in people with Heart Failure, run by Tongji Hospital 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 4 inclusion and 10 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 17 Aug 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li Ni, Phd (862783662479, nili@tjh.tjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NT-proBNP (time frame: 1 month). 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 17 Aug 2021.