Arterial HypertensionPhase 4NCT02087332
Investigator Initiated Randomized Open-label Comparative Study of Britomar (Prolonged Release Torasemide) and Diuver (Torasemide) to Assess Effects on Natriuresis and Central Hemodynamics.
A Phase 4 study testing Prolonged release Torasemide (Britomar) and Torasemide (Diuver) in people with Arterial Hypertension and Chronic Heart Failure, run by Society of Specialists in Heart Failure.
Trial summary
Study hypothesis is that the time from randomization to the increase of natriuresis (%), time to standardization of natriuresis daily profile, blood pressure profile and the percentage reduction of central hemodynamic parameters will be relatively changed over the study period by more than 15%. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Arterial Hypertension, Chronic Heart Failure
- What is being tested?
- Prolonged release Torasemide (Britomar) and Torasemide (Diuver)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- No sites listed yet
- Study dates
- Apr 2014to May 2015
- Phase
- Phase 4
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women in the age from 40 to 70 years.
- Established diagnosis of II-III grade essential arterial hypertension
- NYHA II-III chronic heart failure
- Salt-sensitivity
- Stable therapy for 3 months prior enrollment to the study including any diuretic, ACE-inhibitor, beta-blocker.
- Signed informed consent for participation in the study.
- Women with child-bearing potential should agree to use effective birth control methods from screening up to completion of the study, excluding situations when their sexual partner(s) are surgically sterilized, or whеn women do not have any sexual contacts. Effective methods of birth control are contraception methods which are used constantly and regularly (including implantable contraceptives, injectable contraceptives, oral contraceptives, transdermal contraceptives, intrauterine devices, diaphragms with spermicides, male or female condoms or cervical cap).
Who cannot join
- Unlikely cooperation with a patient in the study period, disability
- Identification of salt - resistance at screening
- Patients that have had myocardial infarction, unstable angina pectoris, percutaneous coronary intervention heart failure, hypertensive encephalopathy, cerebrovascular accident (stroke) or transient ischaemic attack for the last 3 months.
- Patients with severe heart failure (Stage IV of New York Heart Association), clinically significant aortic valve or mitral stenosis, uncorrected coarctation of the aorta, obstruction of cardiac output (obstructive hypertrophic cardiomyopathy)
- Previous glomerulonephritis, severe pyelonephritis or another known severe renal disease which is confirmed by GFR < 40 ml/min/1.73 m2 calculated by Cockroft-Gault formula.
- Secondary arterial hypertension, severe or uncontrolled AH at the study enrollment (BP> 180 mm Hg or DAP > 110 mm Hg)
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- Any severe, decompensated or unstable diseases or conditions which, on the investigator's opinion, endanger patient's life or aggravate disease prognosis (decompensated heart failure, anemia, severe diabetes mellitus, autoimmune, oncological diseases, hepatic, allergic reactions, connective tissue diseases, etc.)
- Acute infectious diseases.
- Hypersensitivity to components of Britomar or Diuver
- Pregnancy, lactation period.
- Participation in another clinical study for the last 30 days.
- Scheduled coronary artery surgery (for example, stent implantation or coronary artery bypass grafting) or any other non-cardiological major surgery.
- 13. Administration of drugs which affect natriuresis level (any diuretics which are not related with the study product). Patients are excluded from the study if they have taken the drugs for the last 48 years up to Visit D -10, in the screening period and/or treatment period/follow-up period of the study.
- Use of narcotic drugs or alcohol abuse for the last 6 months and inability/unwillingness to refrain from narcotic drugs and excessive alcohol intake in the study period. The excessive alcohol intake is average alcohol >2 units of alcohol. A unit of alcohol for various beverages is 12 ounce (350 ml) of beer, 5 ounce (150 ml) of wine or 1.5 ounce (45 ml) of 80% alcohol.
- Any other reason which would hinder patients' compliance with study requirements or their understanding of the study aim and potential risks of participation in study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Randomized Open-label Comparative Study of Britomar (Prolonged Release Torasemide) and Diuver (Torasemide) to Assess Effects on Natriuresis and Central Hemodynamics in Patients With Arterial Hypertension and Chronic Heart Failure
Study hypothesis is that the time from randomization to the increase of natriuresis (%), time to standardization of natriuresis daily profile, blood pressure profile and the percentage reduction of central hemodynamic parameters will be relatively changed over the study period by more than 15%.
- Conditions
- Arterial Hypertension, Chronic Heart Failure
- Being tested
- Prolonged release Torasemide (Britomar), Torasemide (Diuver)
- Keywords
- Kidney damage hypertension cardiovascular diseases, congestive heart failure renal function natriuresis natriuresis monitoring
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prolonged release Torasemide (Britomar)Drug
Torasemide (Diuver)Drug
| Study group | Role | What they receive |
|---|---|---|
| Prolonged release Torasemide (Britomar) | Experimental | Prolonged release Torasemide (Britomar) - round, biconvex, white to off-white tablets debossed SN with one side. 1 tablet contains active substance - torasemide 5 or 10 mg and excipients - guar gum, maize starch, anhydrous colloidal silica, magnesium stearate, lactose.
Dosage scheme: per os, once a day, regardless of meals. The common starting dose in CHF - 10-20 mg once a day. If adequate diuretic effect is absent, the dose is increased approximately twofold up to adequate diuretic effect. Receives: Drug: Prolonged release Torasemide (Britomar) |
| Torasemide (Diuver) | Active comparator | Torasemide (Diuver) - white to off-white, round, biconvex tablets. 1 tablet contain active substance - torasemide 5 or 10 mg and excipients - lactose monohydrate, maize starch, sodium glycolate starch, anhydrous colloidal silica, magnesium stearate. Dosage scheme: per os, once a day, after meals. Therapeutic dose - 5 mg a day. If necessary, a dose may be increased up to 20 mg a day, in some cases - up to 40 mg. Receives: Drug: Torasemide (Diuver) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammatory markers excretion
15% or more increasing of the following Tamm-Horsfall protein, beta-2-microglobulin, osteoponin, TGF- β1 excretion in comperison with baseline level
Measured: 3 months
Secondary outcomes (3)
Daily sodium excretion
Increasing of daily sodium excretion on 30% or more in comparison with baseline
Measured: 3 months
Augmentation index
Decreasing of augmentation index on 30 or more percents in comparison with baseline level
Measured: 3 months
Albuminuria
Appearance of albuminuria of any stage or increasing of albuminuria level in case of existing albuminuria at the baseline. (measured by dipstick)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2014 (estimated)
- Study startApr 2014
- Primary completionMay 2015 (estimated)
- Study completionMay 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arterial 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Society of Specialists in Heart Failure
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Grigory P Arutyunov, Prof, Principal investigator, Russian Society for Heart Failure
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02087332
- Sponsor's protocol ID
- TOR-IIT-001
- Other IDs
- TOR-IIT-001
- Status last verified
- Mar 2014
- First submitted
- 12 Mar 2014
- Last updated
- 20 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Open-label Comparative Study of Britomar (Prolonged Release Torasemide) and Diuver (Torasemide) to Assess Effects on Natriuresis and Central Hemodynamics in Patients With Arterial Hypertension and Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT02087332
- Acronym / sponsor ID
- TOR-IIT-001
- Conditions
- Arterial Hypertension, Chronic Heart Failure
- Keywords
- Kidney damage hypertension cardiovascular diseases, congestive heart failure renal function natriuresis natriuresis monitoring
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Society of Specialists in Heart FailureUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- May 2015 (estimated)
- Study completion
- May 2015 (estimated)
- First posted
- 14 Mar 2014 (estimated)
- 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.
Study hypothesis is that the time from randomization to the increase of natriuresis (%), time to standardization of natriuresis daily profile, blood pressure profile and the percentage reduction of central hemodynamic parameters will be relatively changed over the study period by more than 15%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prolonged release Torasemide (Britomar) | Experimental | Drug: Prolonged release Torasemide (Britomar)Prolonged release Torasemide (Britomar) - round, biconvex, white to off-white tablets debossed SN with one side. 1 tablet contains active substance - torasemide 5 or 10 mg and excipients - guar gum, maize starch, anhydrous colloidal silica, magnesium stearate, lactose. Dosage scheme: per os, once a day, regardless of meals. The common starting dose in CHF - 10-20 mg once a day. If adequate diuretic effect is absent, the dose is increased approximately twofold up to adequate diuretic effect. |
| Torasemide (Diuver) | Active comparator | Drug: Torasemide (Diuver)Torasemide (Diuver) - white to off-white, round, biconvex tablets. 1 tablet contain active substance - torasemide 5 or 10 mg and excipients - lactose monohydrate, maize starch, sodium glycolate starch, anhydrous colloidal silica, magnesium stearate. Dosage scheme: per os, once a day, after meals. Therapeutic dose - 5 mg a day. If necessary, a dose may be increased up to 20 mg a day, in some cases - up to 40 mg. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Men and women in the age from 40 to 70 years.
- Established diagnosis of II-III grade essential arterial hypertension
- NYHA II-III chronic heart failure
- Salt-sensitivity
- Stable therapy for 3 months prior enrollment to the study including any diuretic, ACE-inhibitor, beta-blocker.
Key exclusion criteria (15 listed)
- Unlikely cooperation with a patient in the study period, disability
- Identification of salt - resistance at screening
- Patients that have had myocardial infarction, unstable angina pectoris, percutaneous coronary intervention heart failure, hypertensive encephalopathy, cerebrovascular accident (stroke) or transient ischaemic attack for the last 3 months.
- Patients with severe heart failure (Stage IV of New York Heart Association), clinically significant aortic valve or mitral stenosis, uncorrected coarctation of the aorta, obstruction of cardiac output (obstructive hypertrophic cardiomyopathy)
- Previous glomerulonephritis, severe pyelonephritis or another known severe renal disease which is confirmed by GFR < 40 ml/min/1.73 m2 calculated by Cockroft-Gault formula.
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 |
|---|---|---|
| Prolonged release Torasemide (Britomar) | Drug | Prolonged release Torasemide (Britomar) |
| Torasemide (Diuver) | Drug | Torasemide (Diuver) |
Primary outcome
Inflammatory markers excretion
Time frame: 3 months
15% or more increasing of the following Tamm-Horsfall protein, beta-2-microglobulin, osteoponin, TGF- β1 excretion in comperison with baseline level
3 secondary outcomes
Daily sodium excretion
Time frame: 3 months
Augmentation index
Time frame: 3 months
Albuminuria
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2014.
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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.
Grigory P Arutyunov, Prof principal investigator
Russian Society for Heart Failure
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Prolonged release Torasemide (Britomar) and Torasemide (Diuver) in people with Arterial Hypertension and Chronic Heart Failure, run by Society of Specialists in Heart Failure.
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 7 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 20 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Grigory P Arutyunov, Prof (007(495)952-73-77, arut@ossn.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inflammatory markers excretion (time frame: 3 months). 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 20 Mar 2014.