Back to resultsThe Effects of Neuraminidase Inhibitor Oseltamivir in Patients With Chronic Heart Failure
Primary Purpose
Heart Failure
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Oseltamivir
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring heart failure, Neuraminidase inhibitor, oseltamivir, Neu5Ac, NTproBNP
Eligibility Criteria
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.
Sites / Locations
- Tongji HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Oseltamivir
Arm Description
patients with heart failure to receive standard HF therapy
patients with heart failure to receive oseltamivir (at a dose of 75 mg twice daily) for 1 month in addition to standard HF therapy
Outcomes
Primary Outcome Measures
NT-proBNP
Reduction of NT-proBNP level at 1 month treatment of Oseltamivir
Secondary Outcome Measures
EF (ejection fraction)
Cardiac systolic function assessed by ejection fraction using echocardiography
NYHA Classification
NYHA Classification after treatment of Oseltamivir
Quality of life assessment
Minnesota Heart Failure Quality of life assessment after treatment of Oseltamivir
6-minute walk test
6-minute walk test after treatment of Oseltamivir
Full Information
1. Study Identification
Unique Protocol Identification Number
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.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Recruiting
Study Start Date
February 25, 2021 (Actual)
Primary Completion Date
February 25, 2023 (Anticipated)
Study Completion Date
January 25, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tongji Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
heart failure, Neuraminidase inhibitor, oseltamivir, Neu5Ac, NTproBNP
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
388 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
patients with heart failure to receive standard HF therapy
Arm Title
Oseltamivir
Arm Type
Experimental
Arm 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 Type
Drug
Intervention Name(s)
Oseltamivir
Other Intervention Name(s)
Neuraminidase Inhibitor
Intervention Description
at a dose of 75 mg twice daily
Primary Outcome Measure Information:
Title
NT-proBNP
Description
Reduction of NT-proBNP level at 1 month treatment of Oseltamivir
Time Frame
1 month
Secondary Outcome Measure Information:
Title
EF (ejection fraction)
Description
Cardiac systolic function assessed by ejection fraction using echocardiography
Time Frame
1month, 6 months
Title
NYHA Classification
Description
NYHA Classification after treatment of Oseltamivir
Time Frame
1month, 6 months
Title
Quality of life assessment
Description
Minnesota Heart Failure Quality of life assessment after treatment of Oseltamivir
Time Frame
1month, 6 months
Title
6-minute walk test
Description
6-minute walk test after treatment of Oseltamivir
Time Frame
1month, 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Li Ni, Phd
Phone
862783662479
Email
nili@tjh.tjmu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dao Wen Wang, Phd
Organizational Affiliation
Tongji Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tongji Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Ni, PHD
Phone
+862783662479
Email
nili@tjh.tjmu.edu.cn
12. IPD Sharing Statement
Learn more about this trial
The Effects of Neuraminidase Inhibitor Oseltamivir in Patients With Chronic Heart Failure
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