HYDrochlorothiazidE compared to valsartan to treat arterial hypertension in patients with Hypertrophic obstructive CardioMyopathy – the HYDE-HCM Trial

Trial details

Who runs it

Medical University Of Graz

Trial code

EU 2024-520086-31-00

Record updated

2025. december 29.

Original description

To assess if in patients with HOCM and arterial hypertension, low dose HCT increases peak LVOT gradient at rest to a significantly lesser extent than valsartanRead full original descriptionShow less

HYDrochlorothiazidE compared to valsartan to treat arterial hypertension in patients with Hypertrophic obstructive CardioMyopathy – the multicenter, randomized, double-blind, controlled, crossover HYDE-HCM Trial

To assess if in patients with HOCM and arterial hypertension, low dose HCT increases peak LVOT gradient at rest to a significantly lesser extent than valsartan

Inclusion: Diagnosis of HCM consistent with the current Guidelines of the European Society of Cardiology and American College of Cardiology Foundation/American Heart Association: presence of increased left ventricular wall thickness (≥15mm or ≥13mm with positive family history of HCM) in any myocardial segment that is not explained solely by loading conditions; SAM-associated LVOTO, defined as peak LVOT pressure gradient ≥ 30mmHg at rest assessed 30 to 60 minutes after standardized meal intake; Fasting office blood pressure ≥ 135/85 mmHg (either systolic or diastolic BP increased), measured as standardized office blood pressure after at least six hours of fasting; Treatment with cardioselective betablocker in maximally tolerated dose or intolerance/contraindication to betablocker; Age ≥ 18 years; Female participants are eligible to participate if they are not pregnant or breastfeeding, and at least 1 of the following conditions applies: o is not a women of childbearing potential (WOCBP) or o is a WOCBP and using a contraceptive method that is highly effective (failure rate <1% per year) during the intervention period; No additional contraceptive measures are required to be used for male participants; Willingness and ability to provide signed written informed consent form (ICF) in accordance with regulatory, local, and institutional guidelines.

Exclusion: Initiation or change in myosin-inhibitor therapy 52 weeks prior to randomization or planned initiation during the active study period; Completed a study with an investigational device or drug <30 days or 5 half-lives to screening; Enrolled in another study and receiving any investigational treatment (device or drug); Current treatment or treatment within 2 weeks prior to randomization with either a thiazide diuretic or an angiotensin receptor blocker; Change in antihypertensive therapy within 2 weeks prior to randomization and up to the day of randomization; Invasive septal reduction therapy (surgical myectomy or percutaneous alcohol septal ablation) within 6 months prior to screening or planned invasive septal reduction therapy during the study; Known infiltrative or storage disorder causing cardiac hypertrophy that mimics HCM, such as amyloidosis, Fabry disease, Noonan syndrome, or other HCM-phenocopies; Known allergy to HCT or valsartan or their constituents, or to medications with a similar chemical structure; Any other serious condition that in the opinion of the investigator could prevent participation in the study; Any other contraindication for treatment with either HCT or valsartan, including: • eGFR <30mL/min and/or serum creatinine >1.8mg/100mL • acute glomerulonephritis • severe hepatic zirrhosis or failure, hepatic precoma/coma • systolic blood pressure <90mmHg • heart rate <50bpm • sodium <130mmol/L • total calcium >2.65mmol/L • gout • second and third trimester of pregnancy; Concomitant use of Aliskiren in patients with diabetes mellitus or renal disease (estimated glomerular filtration rate [eGFR] <60mL/min); Women who are breastfeeding or pregnant.

EU CTIS 2024-520086-31-00