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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00606736
Other study ID # HMU-007
Secondary ID HMU-008
Status Withdrawn
Phase N/A
First received January 22, 2008
Last updated July 2, 2015
Start date January 2008
Est. completion date December 2008

Study information

Verified date January 2008
Source Harbin Medical University
Contact n/a
Is FDA regulated No
Health authority China: Ethics Committee
Study type Observational

Clinical Trial Summary

The purpose of this study is to determine whether the occurrence of idiopathic right ventricular outflow tract(RVOT) arrhythmia is relative to sex hormone levels in different stages of female menstrual cycle


Description:

The predilection site of idiopathic ventricular arrhythmia is right ventricular outflow tract ,which is called idiopathic RVOT arrhythmia , a retrospective study reported the females are susceptibility to this kind of arrhythmia and another questionaire survey of triggers for RVOT-VT initiation indicated that women have RVOT-A initiation with recognized states of sex hormonal flux , but few researches were made to study the exact relation between this kind of arrhythmia and sex hormone levels, this is the aim of our study .40 females with regular menses(20 females with RVOT arrhythmia ,20 healthy volunteers) will be screened, the Participants will undergo ECG monitoring and their blood samples will be collected at various times throughout the study.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 2008
Est. primary completion date December 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 45 Years
Eligibility Inclusion Criteria:

- Must be female

- Aged 20 to 45 years, with regular menstrual cycles.

- With normal BMI

- Without organic heart disease

- Healthy volunteers and women with RVOT arrhythmia are both being recruited.

Exclusion Criteria:

- Pregnancy

- Use of hormonal therapy including birth control pills or other drugs

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
China Cardiology Department of the 4Th Hospital of Harbin Medical University Harbin Heilongjiang

Sponsors (1)

Lead Sponsor Collaborator
Harbin Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary number and duration of right ventricular outflow tract arrhythmia one month Yes
Secondary sex hormone levels one month Yes
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