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)

Condition studied

Long QT syndrome

Investigational medicinal product(s)

Every trial of Estradiol and Progesterone across our registers →

Eligibility

Primary endpoint

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

Endpoint detail

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.