Evaluation of Clinical and Genetic Modifiers of Long-term Survival in Heart Failure

Heart Failure Clinical Trial

Official title:

Evaluation of Beta-adrenergic Receptor Gene Polymorphisms in the Long-term Effects of Beta-blockade in Patients With Chronic Heart Failure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03461107
• Other study ID #: TJ-HF-ARB
• Status: Recruiting
• Start date: April 18, 2016
• Est. completion date: December 31, 2020

Study information

• Verified date: April 2019
• Source: Tongji Hospital
• Contact: Li Ni, doctor
• Phone: 86-27-83663280
• Email: nili[@]tjh.tjmu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to evaluate the beta-adrenergic receptor gene polymorphisms in the long-term effects of beta-blockade in patients with chronic heart failure.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2500
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 18 years of age or older;

2. Patients are required to have chronic heart failure (NYHA II-IV) with a left ventricular ejection fraction lower than 40%;

3. Patients are voluntary and signed informed consent.

Exclusion Criteria:

1. Pregnant women or plan to;

2. Participate in any drug clinical trials within 3 months;

3. Serious neurological disease (Alzheimer's disease, Parkinson syndrome, progressive lower limbs or deaf patients);

4. Previous history of cancer or tumor, or pathological examination confirmed precancerous lesions;

5. Patients refused to comply with the requirements of this study to complete the research work;

6. According to the researchers, patients can not complete the study or not to comply with the requirements of this study (because of the reasons for the management or other reasons).

Related Conditions & MeSH terms

• Heart Failure

Intervention

Other:
• No intervention

Locations

Country	Name	City	State
China	Tongji Hospital	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Tongji Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiovascular death		up to 24 months
Primary	Heart transplantation		up to 24 months
Secondary	All cause death		up to 24 months
Secondary	Heart failure recuring		up to 24 months
Secondary	Readmission because of cardiovascular diseases		up to 24 months