The Link Between the Clinical Resting Heart Rate and Sympathetic Overactivation

Cardiovascular Disease Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02315313
• Other study ID #: ESR-14-10153
• Status: Not yet recruiting
• Phase: N/A
• First received: December 2, 2014
• Last updated: December 8, 2014
• Start date: December 2014

Study information

• Verified date: December 2014
• Source: Ruijin Hospital
• Contact: Jiguang Wang, PHD
• Phone: 13764189476
• Email: wangjiguang2000[@]126.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial Summary

It is a retrospective study with no products limitation to investigate the link between clinical resting HR and SOA. Use HR≤60bpm as control group, compare other three groups with the control group and find out the correlation between HR and SOA indexes.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Provision of subject informed written or oral consent

2. Female and male aged= 20 to = 80 years;

3. Records on mean clinical heart rate and SOA indexes were available.

Exclusion Criteria:

1. Participation in another clinical study with an investigational product during the last 6 months;

2. Drug intervention on heart rate 1 month prior to the inclusion;

3. Patients with missing data in the database from the Shanghai Institute of Hypertension, Ruijin Hospital, Shanghai.

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The difference of HRV, BPV, LF/HF between each groups	The difference on mean sympathetic overactivation related indexes such as HRV, BPV, LF/HF between groups	1min HR measure	No