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Pharmacogenetics of Torasemide and Spironolactone in Hypertension Treatment | Clinical Trials | Clareo Health

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Pharmacogenetics of Torasemide and Spironolactone in Hypertension Treatment

Pharmacogenetics of Hypertension: a Single-centre Randomized Study in Patients With Essential Hypertension Treated With Spironolactone or Torasemide

NCT06413082•Ospedale San Raffaele

View on ClinicalTrials.gov

Summary

Phase III interventional study to evaluate the different efficacy of Torasemide and Spironolactone in reducing systolic blood pressure in carriers and non-carriers of the different genotypic combinations for Lanosterol and Uromodulin

Detailed Description

The investigators will enroll 144 naïve hypertensive subjects who will undertake 2-4 weeks of run-in and 4 weeks of treatment (7 day window at each visit). During this period partecipants will follow a low sodium diet (about 5g/day) and will be monitored with blood chemistry tests

Eligibility

Age

25 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•male (25-65 years) and female (45-65 years in menopause defined as "12 consecutive months of amenorrhea for which no other physiological or pathological cause has been identified in woman over 45 years of age")
•newly diagnosed hypertensive patients never treated before or on single antihypertensive drug therapy
•hypertension grade I or II (according to 2013 ESH guidelines, in the patient untreated or despite therapy), defined as the following:
•* at visits T-4 and T-2 (week -4 and week -2 ± 7 days, run-in period) the mean of the last 3 consecutive SBP measurements must be \>=140 mmHg and/or diastolic BP\>= 90mmHg
•* at the T0 visit (week 0 ± 7 days, enrollment), the mean of the last 3 consecutive systolic BP measurements must be \>=140 mmHg and \<180 mmHg and diastolic BP must be \>=90 mmHg and \<110 mmHg
•signing of the informed consent for participation in the study and for genotyping.

Exclusion Criteria

•known causes of secondary hypertension
•stage II hypertension (SBP\>= 180 and SBP\>=110 mmHg
•history of renal artery stenosis
•significant kidney disease (eGFR-CK-EPI less than 60 mL/min)
•refractory hypokalemia or hyponatremia (Napl \< 126 mEq/L)
•hyperkalemia (K \> 5.5 mEq/l)
•hypercalcemia
•symptomatic hyperuricemia
•liver disease (transaminases greater than 3 times the maximum laboratory value)
•cardiac pathologies (previous myocardial infarction, atrial fibrillation in progress, etc.)
+11 more criteria

Locations (2)

San Raffaele Hospital

Milan, Lombardy, Italy

IRCCS Ospedale San Raffaele

Milan, Italy

Key Dates

Start Date

February 15, 2021

Primary Completion Date

July 7, 2023

Completion Date

September 3, 2023

Last Updated

May 16, 2024

Enrollment

ACTUAL participants

Conditions

HypertensionGenetic PredispositionDrug Effect

Interventions

Torasemide

DRUG

Spironolactone

DRUG

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RECRUITING

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 16, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Pharmacogenetics of Torasemide and Spironolactone in Hypertension Treatment

Inclusion Criteria

Exclusion Criteria

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