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

  • STATUS
    Recruiting
  • End date
    Jan 25, 2024
  • participants needed
    388
  • sponsor
    Tongji Hospital
Updated on 22 August 2021
heart failure
aldosterone
chronic heart failure
nt-probnp
angiotensin
angiotensin converting enzyme

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), -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.

Details
Condition Heart failure, Heart disease, Congestive Heart Failure, Heart Failure, cardiac failure, Heart Disease, congestive heart disease, Cardiac Disease
Treatment Oseltamivir
Clinical Study IdentifierNCT05008679
SponsorTongji Hospital
Last Modified on22 August 2021

Eligibility

Yes No Not Sure

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
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