NCT05008679

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
388

participants targeted

Target at P75+ for not_applicable heart-failure

Timeline
Completed

Started Feb 2021

Typical duration for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 25, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 14, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 17, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2023

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2024

Completed
Last Updated

August 17, 2021

Status Verified

August 1, 2021

Enrollment Period

2 years

First QC Date

August 14, 2021

Last Update Submit

August 14, 2021

Conditions

Heart Failure

Keywords

heart failureNeuraminidase inhibitoroseltamivirNeu5AcNTproBNP

Outcome Measures

Primary Outcomes (1)

  • NT-proBNP

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

    1 month

Secondary Outcomes (4)

  • EF (ejection fraction)

    1month, 6 months

  • NYHA Classification

    1month, 6 months

  • Quality of life assessment

    1month, 6 months

  • 6-minute walk test

    1month, 6 months

Study Arms (2)

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

Drug: Oseltamivir

Interventions

OseltamivirDRUG

at a dose of 75 mg twice daily

Also known as: Neuraminidase Inhibitor
Oseltamivir

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tongji Hospital

Wuhan, Hubei, 430030, China

RECRUITING

MeSH Terms

Conditions

Heart Failure

Interventions

Oseltamivir

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

AcetamidesAmidesOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbons

Study Officials

  • Dao Wen Wang, Phd

    Tongji Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Li Ni, Phd

CONTACT

862783662479nili@tjh.tjmu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 14, 2021

First Posted

August 17, 2021

Study Start

February 25, 2021

Primary Completion

February 25, 2023

Study Completion

January 25, 2024

Last Updated

August 17, 2021

Record last verified: 2021-08

Locations

CN(1)