Ignite Creation Date:
2025-12-24 @ 1:27 PM
Ignite Modification Date:
2025-12-29 @ 12:38 PM
Study NCT ID:
NCT02931695
Status:
COMPLETED
Last Update Posted:
2024-01-05
First Post:
2016-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Sex Hormones Variation During Third Trimester of Pregnancy and Post-partum on QT Interval Duration
Sponsor:
French Cardiology Society
Organization:
Study Overview
Official Title:
Influence of Sex Hormones Variation During Third Trimester of Pregnancy and Post-partum on QT Interval Duration
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
QuTe
Brief Summary:
QT interval prolongation, corrected for heart rate (QTc), either spontaneous or drug-induced, is associated with an increased risk of torsades de pointes and sudden death. Women are at higher risk of torsades de pointes, particularly during post-partum and the follicular phase.
The aim of this study is to explore if QTc duration is prolonged during post-partum as compared to the 3rd trimester of pregnancy
The aim of this study is to explore if QTc duration is prolonged during post-partum as compared to the 3rd trimester of pregnancy
Detailed Description:
Sex steroid hormones are known to influence heart repolarization. Overall, estradiol is considered to promote QTc lengthening while progesterone and testosterone shorten QTc. New findings suggest more complex regulation of QTc by sex steroid hormones involving also follicle-stimulating hormone, which is associated to prolongation of QTc. Another important aim of this study is to study the influence of sex hormones on QTc duration.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: