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Influence of menarche and menstrual cycle on QTc interval in girls with genotype positive LQT1 and LQT2

Influence of menarche and menstrual cycle on QTc interval in girls with genotype positive LQT1 and LQT2 - Influence of menarche and menstrual cycle in LQTS

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON45048
Enrollment
25
Registered
2015-10-30
Start date
2016-02-01
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital long QT syndrome LQTS

Interventions

None listed

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
12 Years to 99 Years

Inclusion criteria

Inclusion criteria: All girls must meet the following inclusion criteria * Post-menarcheal * Genetically confirmed LQT1 and LQT2 * Between the age of 12 and 21 years

Exclusion criteria

Exclusion criteria: * Premenarcheal * Pregnancy * The use of hormonal contraceptive therapy (i.e. combined estrogen- progestin oral contraceptives, intrauterine contraception, contraceptive vaginal ring, etonogestrel contraceptive implant, injectable contraceptives or progestin pills) * Body mass index (BMI) for age greater or less than the 95th percentile * History of polycystic ovary syndrome (PCOS) or anorexia nervosa * Double mutation carrier or compound heterozygote * Mutations of unknown pathology

Design outcomes

Primary

MeasureTime frame
The QTc interval will be measured pre- and post-menarche and during three phases of the menstrual cycle, with concomitant estradiol and pregnanediol fluctuations.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)