HypertensionPhase 3ALTUMNCT06413082
Pharmacogenetics of Torasemide and Spironolactone in Hypertension Treatment
A Phase 3 study testing Torasemide and Spironolactone in people with Hypertension and Genetic Predisposition, run by Ospedale San Raffaele at 2 sites in Italy.
Trial 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 Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Hypertension, Genetic Predisposition, Drug Effect
- What is being tested?
- Torasemide and Spironolactone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 2 sitesItaly
- Study dates
- 15 Feb 2021to 3 Sep 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
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- hypercalcemia
- symptomatic hyperuricemia
- liver disease (transaminases greater than 3 times the maximum laboratory value)
- cardiac pathologies (previous myocardial infarction, atrial fibrillation in progress, etc.)
- diabetes (fasting blood sugar >126mg/dL)
- -. current statin treatment
- obesity (BMI >30 kg/m2)
- ongoing pregnancy
- breastfeeding in progress
- anuria
- hypovolemia and dehydration
- known hypersensitivity to the study drugs (Spironolactone or Torasemide) or to any of the excipients
- ongoing therapy with aminoglycosides or cephalosporins
- participation in a clinical study in which an investigational drug was administered within 30 days or 5 half-lives prior to the study drug
- patients unable to express valid consent
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
San Raffaele Hospital
Milan, Lombardy, 20132
IRCCS Ospedale San Raffaele
Milan, 20132
About this study
Official title: Pharmacogenetics of Hypertension: a Single-centre Randomized Study in Patients With Essential Hypertension Treated With Spironolactone or Torasemide
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
Read the 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
- Conditions
- Hypertension, Genetic Predisposition, Drug Effect
- Being tested
- Torasemide, Spironolactone
- Keywords
- hypertension, genetics, torasemide, spironolactone, pharmacogenetics
- Medical subject headings
- Hypertension, Genetic Predisposition to Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TorasemideDrug
Also called Demadex, Tortas, Wator, Torsemide
The assignment to each drug will be carried out randomly in each genotypic group with the aim of reaching the same number of patients treated with the two drugs in the different genotypic groups
SpironolactoneDrug
Also called Aldactone, Carospir
The assignment to each drug will be carried out randomly in each genotypic group with the aim of reaching the same number of patients treated with the two drugs in the different genotypic groups
| Study group | Role | What they receive |
|---|---|---|
| Torasemide | Experimental | The study involves the administration of Torasemide 2.5 mg. Receives: Drug: Torasemide |
| Spironolactone | Experimental | The study involves the administration of Spironolactone 50 mg orally every day. Receives: Drug: Spironolactone |
What is being measured
The primary outcome is the main question the study is designed to answer.
difference in the change of systolic blood pressure(deltaSBP)
the difference in the reduction of systolic blood pressure (deltaSBP) values in essential hypertensive patients who are carriers and noncarriers of the different genotypic combinations for the LSS (lanosterol synthase) and UMOD (uromodulin) genes in response to Spironolactone or Torasemide
Measured: week 4 vs. week 0
Secondary outcomes (2)
difference in diastolic blood pressure change after treatment with Spironolactone or difference in diastolic blood pressure reduction (deltaDBP)
the difference in the reduction of diastolic blood pressure (deltaDBP) values in essential hypertensive patients who are carriers and noncarriers of the different genotypic combinations for the LSS (lanosterol synthase) and UMOD (uromodulin) genes in response to Spironolactone or Torasemide
Measured: week 4 vs. week 0
variation of plasma aldosterone
variation of plasma aldosterone levels in the different genotypic and treatment groups after 4 weeks of treatment.
Measured: week 4 vs. week 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2024
- Study start15 Feb 2021
- Primary completion7 Jul 2023
- Study completion3 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- single-center, nationwide, randomized, phase III prospective interventional outpatient study, in two arms, in parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ospedale San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chiara Lanzani, Ospedale San Raffaele
- Investigators
- Paolo Manunta, MD, Study director, San Raffaele Hospital Milan, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06413082
- Sponsor's protocol ID
- ALTUM
- Acronym
- ALTUM
- Status last verified
- May 2024
- First submitted
- 4 Sep 2023
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IDP will be stored in the institutional repository.
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacogenetics of Hypertension: a Single-centre Randomized Study in Patients With Essential Hypertension Treated With Spironolactone or Torasemide
- ClinicalTrials.gov ID
- NCT06413082
- Acronym / sponsor ID
- ALTUM / ALTUM
- Conditions
- Hypertension, Genetic Predisposition, Drug Effect
- Keywords
- hypertension, genetics, torasemide, spironolactone, pharmacogenetics
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Ospedale San RaffaeleUniversity, hospital or other
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 7 Jul 2023 (actual)
- Study completion
- 3 Sep 2023 (actual)
- First posted
- 14 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- single-center, nationwide, randomized, phase III prospective interventional outpatient study, in two arms, in parallel groups
| Arm | Type | Receives |
|---|---|---|
| Torasemide | Experimental | Drug: TorasemideThe study involves the administration of Torasemide 2.5 mg. |
| Spironolactone | Experimental | Drug: SpironolactoneThe study involves the administration of Spironolactone 50 mg orally every day. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
- signing of the informed consent for participation in the study and for genotyping.
Key exclusion criteria (21 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TorasemideAlso: Demadex, Tortas, Wator, TorsemideThe assignment to each drug will be carried out randomly in each genotypic group with the aim of reaching the same number of patients treated with the two drugs in the different genotypic groups | Drug | Torasemide |
| SpironolactoneAlso: Aldactone, CarospirThe assignment to each drug will be carried out randomly in each genotypic group with the aim of reaching the same number of patients treated with the two drugs in the different genotypic groups | Drug | Spironolactone |
Primary outcome
difference in the change of systolic blood pressure(deltaSBP)
Time frame: week 4 vs. week 0
the difference in the reduction of systolic blood pressure (deltaSBP) values in essential hypertensive patients who are carriers and noncarriers of the different genotypic combinations for the LSS (lanosterol synthase) and UMOD (uromodulin) genes in response to Spironolactone or Torasemide
2 secondary outcomes
difference in diastolic blood pressure change after treatment with Spironolactone or difference in diastolic blood pressure reduction (deltaDBP)
Time frame: week 4 vs. week 0
variation of plasma aldosterone
Time frame: week 4 vs. week 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Individual participant dataSharing planned: No. IDP will be stored in the institutional repository.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paolo Manunta, MD study director
San Raffaele Hospital Milan, Italy
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Torasemide and Spironolactone in people with Hypertension and Genetic Predisposition, run by Ospedale San Raffaele at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
difference in the change of systolic blood pressure(deltaSBP) (time frame: week 4 vs. week 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.