Effects of Menopausal Hormone Therapy on QTc in Genetically Confirmed Long QT Syndrome: A Prospective Randomized Sequential Crossover Study with Long-Term Observational Follow-Up (LQTS-HER)

Conditions

Long QT syndrome

Brief summary

Maximum change in QTc (ΔQTc, ms) on ECG from baseline during each 4-week MHT treatment period.

Detailed description

Secondary safety endpoint: Occurrence and number of specific VAs during each MHT period and follow-up, as detected by ILR monitoring., Exploratory endpoint: Within-subject differences in maximum change in QTc (ΔQTc, ms) on ECG between different MHT regimens., Exploratory endpoint: Agreement between semi-manual QTc measured on ILR recordings and QTc obtained from concurrent standard 12-lead ECG recordings, Secondary safety endpoint: Occurrence and number of severe VAs during Part 2, as detected by ILR monitoring., Exploratory endpoint: Change in QTc (ΔQTc, ms) from Part 1 baseline to each Part 2 follow-up visit during MHT prescribed in routine clinical care., Exploratory endpoint: Change in Menopause Rating Scale total score from the end of Part 1 to each Part 2 follow-up visit.

Related papers

No related papers found yet.

Interventions

DRUGEstradot 50 mikrog/24 timer depotplaster

DRUGEstrogel 0

DRUG75 mg/dose transdermalgel

DRUGUtrogestan 100 mg myk kapsel

DRUGESTRADIOL

DRUGLenzetto 1

DRUG53 mg/spray transdermal spray

DRUGoppløsning

DRUGNORETHISTERONE ACETATE

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Maximum change in QTc (ΔQTc, ms) on ECG from baseline during each 4-week MHT treatment period.	—

Secondary

Measure	Time frame
Secondary safety endpoint: Occurrence and number of specific VAs during each MHT period and follow-up, as detected by ILR monitoring., Exploratory endpoint: Within-subject differences in maximum change in QTc (ΔQTc, ms) on ECG between different MHT regimens., Exploratory endpoint: Agreement between semi-manual QTc measured on ILR recordings and QTc obtained from concurrent standard 12-lead ECG recordings, Secondary safety endpoint: Occurrence and number of severe VAs during Part 2, as detected by ILR monitoring., Exploratory endpoint: Change in QTc (ΔQTc, ms) from Part 1 baseline to each Part 2 follow-up visit during MHT prescribed in routine clinical care., Exploratory endpoint: Change in Menopause Rating Scale total score from the end of Part 1 to each Part 2 follow-up visit.	—

Measure

Time frame

Secondary safety endpoint: Occurrence and number of specific VAs during each MHT period and follow-up, as detected by ILR monitoring., Exploratory endpoint: Within-subject differences in maximum change in QTc (ΔQTc, ms) on ECG between different MHT regimens., Exploratory endpoint: Agreement between semi-manual QTc measured on ILR recordings and QTc obtained from concurrent standard 12-lead ECG recordings, Secondary safety endpoint: Occurrence and number of severe VAs during Part 2, as detected by ILR monitoring., Exploratory endpoint: Change in QTc (ΔQTc, ms) from Part 1 baseline to each Part 2 follow-up visit during MHT prescribed in routine clinical care., Exploratory endpoint: Change in Menopause Rating Scale total score from the end of Part 1 to each Part 2 follow-up visit.

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Outcome results

None listed