The Effects of Neuraminidase Inhibitor Oseltamivir in Patients With Chronic Heart Failure

Sponsor

Tongji Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05008679

Collaborator

(none)

388

Enrollment

Location

Arms

Anticipated Duration (Months)

11.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Drug: Oseltamivir	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

388 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

The Effects of Neuraminidase Inhibitor Oseltamivir in Patients With Chronic Heart Failure: an Open Label, Randomized, Blank-controlled Study.

Actual Study Start Date :

Feb 25, 2021

Anticipated Primary Completion Date :

Feb 25, 2023

Anticipated Study Completion Date :

Jan 25, 2024

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control patients with heart failure to receive standard HF therapy
Experimental: Oseltamivir patients with heart failure to receive oseltamivir (at a dose of 75 mg twice daily) for 1 month in addition to standard HF therapy	Drug: Oseltamivir at a dose of 75 mg twice daily Other Names: Neuraminidase Inhibitor

Arm

Intervention/Treatment

No Intervention: Control

patients with heart failure to receive standard HF therapy

Experimental: Oseltamivir

patients with heart failure to receive oseltamivir (at a dose of 75 mg twice daily) for 1 month in addition to standard HF therapy

Drug: Oseltamivir

at a dose of 75 mg twice daily

Other Names:

Neuraminidase Inhibitor

Outcome Measures

Primary Outcome Measures

NT-proBNP [1 month]
Reduction of NT-proBNP level at 1 month treatment of Oseltamivir

Secondary Outcome Measures

EF (ejection fraction) [1month, 6 months]
Cardiac systolic function assessed by ejection fraction using echocardiography
NYHA Classification [1month, 6 months]
NYHA Classification after treatment of Oseltamivir
Quality of life assessment [1month, 6 months]
Minnesota Heart Failure Quality of life assessment after treatment of Oseltamivir
6-minute walk test [1month, 6 months]
6-minute walk test after treatment of Oseltamivir

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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;
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.