Clinical Trials Directory

Trials / Completed

CompletedNCT02931695

Influence of Sex Hormones Variation During Third Trimester of Pregnancy and Post-partum on QT Interval Duration

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
80 (actual)
Sponsor
French Cardiology Society · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Accepted

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

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.

Conditions

Interventions

TypeNameDescription
OTHERevaluation of QT interval durationECG to evaluation of QT interval duration
OTHERcirculating sex hormones levels sampleAssociation between circulating sex hormones levels (progesterone, estradiol, testosterone, FSH) and QTcF duration (univariate and multivariate analysis).

Timeline

Start date
2017-04-24
Primary completion
2022-04-24
Completion
2023-10-24
First posted
2016-10-13
Last updated
2024-01-05

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT02931695. Inclusion in this directory is not an endorsement.