## Protocol Section
### Identification Module
**NCT ID:** NCT05008679

**Brief Title:** The Effects of Neuraminidase Inhibitor Oseltamivir in Patients With Chronic Heart Failure

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

#### Organization Study ID Info
**ID:** TJ-HF-NI
#### Organization
**Class:** OTHER
**Full Name:** Tongji Hospital
### Status Module
#### Completion Date
**Date:** 2024-01-25

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2021-08-17

**Type:** ACTUAL

**Last Update Submit Date:** 2021-08-14

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2023-02-25

**Type:** ESTIMATED

#### Start Date
**Date:** 2021-02-25

**Type:** ACTUAL

**Status Verified Date:** 2021-08

#### Study First Post Date
**Date:** 2021-08-17
**Type:** ACTUAL
**Study First Submit Date:** 2021-08-14
**Study First Submit QC Date:** 2021-08-14
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Tongji Hospital

#### Responsible Party

**Investigator Affiliation:** Tongji Hospital

**Investigator Full Name:** Dao Wen Wang

**Investigator Title:** Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Heart Failure

**Keywords:**

- heart failure

- Neuraminidase inhibitor

- oseltamivir

- Neu5Ac

- NTproBNP

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 388

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** patients with heart failure to receive standard HF therapy

**Label:** Control

**Type:** NO_INTERVENTION

#### Arm Group 2

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

**Intervention Names:**

- Drug: Oseltamivir

**Label:** Oseltamivir

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Oseltamivir

**Description:** at a dose of 75 mg twice daily

**Name:** Oseltamivir

**Other Names:**

- Neuraminidase Inhibitor

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Reduction of NT-proBNP level at 1 month treatment of Oseltamivir

**Measure:** NT-proBNP

**Time Frame:** 1 month

#### Secondary Outcomes

**Description:** Cardiac systolic function assessed by ejection fraction using echocardiography

**Measure:** EF (ejection fraction)

**Time Frame:** 1month, 6 months

**Description:** NYHA Classification after treatment of Oseltamivir

**Measure:** NYHA Classification

**Time Frame:** 1month, 6 months

**Description:** Minnesota Heart Failure Quality of life assessment after treatment of Oseltamivir

**Measure:** Quality of life assessment

**Time Frame:** 1month, 6 months

**Description:** 6-minute walk test after treatment of Oseltamivir

**Measure:** 6-minute walk test

**Time Frame:** 1month, 6 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. 18 of age or older, regardless of gender;
2. Patients with NYHA II-IV, LVEF less than 40%;
3. Levels of NT-proBNP more than 450 pg/ml
4. Willing to participate in this study and sign an informed consent, and receive follow-up contact for at least 6 months.

Exclusion Criteria:

1. Onset of acute myocardial infarction within the last 1 month;
2. Had cardiac surgery or onset of cerebrovascular accident within the last 6 months;
3. Plan to have cardiac transplantation or CRT, or already having CRT therapy;
4. Females with pregnancy or plan to have pregnancy;
5. Have participate in any other clinical trial within the last 3 months;
6. Severe neurological disorders (Alzheimer's disease, progressive stage of Parkinson's syndrome), disabilities of lower limbs or deaf-mute;
7. had a history of tumour, or precancerous lesions confirmed by pathological tests (ductal carcinoma in situ, cervical dysplasia, etc.);
8. 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.);
9. The subjects who refuse to comply with the items of the research protocol;
10. 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.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** nili@tjh.tjmu.edu.cn

**Name:** Li Ni, Phd

**Phone:** 862783662479

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Wuhan

**Contacts:**

***Contact 1:***

- **Email:** nili@tjh.tjmu.edu.cn

- **Name:** Li Ni, PHD

- **Phone:** +862783662479

- **Role:** CONTACT

**Country:** China

**Facility:** Tongji Hospital

**State:** Hubei

**Status:** RECRUITING

**Zip:** 430030

#### Overall Officials

**Official 1:**

**Affiliation:** Tongji Hospital

**Name:** Dao Wen Wang, Phd

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000006331

- Term: Heart Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M9421

- Name: Heart Failure

- Relevance: HIGH

- As Found: Heart Failure

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006333

- Term: Heart Failure

### Intervention Browse Module - Ancestors

- ID: D000000998

- Term: Antiviral Agents

- ID: D000000890

- Term: Anti-Infective Agents

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

### Intervention Browse Module - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Infe

- Name: Anti-Infective Agents

### Intervention Browse Module - Browse Leaves

- ID: M4673

- Name: Azacitidine

- Relevance: LOW

- As Found: Unknown

- ID: M27146

- Name: Oseltamivir

- Relevance: HIGH

- As Found: Self-help

- ID: M4314

- Name: Antiviral Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4214

- Name: Anti-Infective Agents

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000053139

- Term: Oseltamivir

### Misc Info Module

- Version Holder: 2024-05-24
