Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Investigator Initiated Randomized Open-label Comparative Study of Britomar (Prolonged Release Torasemide) and Diuver (Torasemide) to Assess Effects on Natriuresis and Central Hemodynamics.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02087332
Recruitment Status : Unknown
Verified March 2014 by Society of Specialists in Heart Failure.
Recruitment status was:  Not yet recruiting
First Posted : March 14, 2014
Last Update Posted : March 20, 2014
Sponsor:
Information provided by (Responsible Party):
Society of Specialists in Heart Failure

Brief 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%.

Condition or disease Intervention/treatment Phase
Arterial Hypertension Chronic Heart Failure Drug: Prolonged release Torasemide (Britomar) Drug: Torasemide (Diuver) Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : April 2014
Estimated Primary Completion Date : May 2015
Estimated Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
Drug Information available for: Torsemide

Arm Intervention/treatment
Experimental: 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.

Drug: Prolonged release Torasemide (Britomar)
Active Comparator: 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.
Drug: Torasemide (Diuver)



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Daily sodium excretion [ Time Frame: 3 months ]
    Increasing of daily sodium excretion on 30% or more in comparison with baseline

  2. Augmentation index [ Time Frame: 3 months ]
    Decreasing of augmentation index on 30 or more percents in comparison with baseline level

  3. Albuminuria [ Time Frame: 3 months ]
    Appearance of albuminuria of any stage or increasing of albuminuria level in case of existing albuminuria at the baseline. (measured by dipstick)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Men and women in the age from 40 to 70 years.
  2. Established diagnosis of II-III grade essential arterial hypertension
  3. NYHA II-III chronic heart failure
  4. Salt-sensitivity
  5. Stable therapy for 3 months prior enrollment to the study including any diuretic, ACE-inhibitor, beta-blocker.
  6. Signed informed consent for participation in the study.
  7. 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).

Exclusion Criteria:

  1. Unlikely cooperation with a patient in the study period, disability
  2. Identification of salt - resistance at screening
  3. 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.
  4. 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)
  5. 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.
  6. Secondary arterial hypertension, severe or uncontrolled AH at the study enrollment (BP> 180 mm Hg or DAP > 110 mm Hg)
  7. 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.)
  8. Acute infectious diseases.
  9. Hypersensitivity to components of Britomar or Diuver
  10. Pregnancy, lactation period.
  11. Participation in another clinical study for the last 30 days.
  12. Scheduled coronary artery surgery (for example, stent implantation or coronary artery bypass grafting) or any other non-cardiological major surgery.
  13. 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.
  14. 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.
  15. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02087332


Contacts
Layout table for location contacts
Contact: Grigory P Arutyunov, Prof 007(495)952-73-77 arut@ossn.ru

Sponsors and Collaborators
Society of Specialists in Heart Failure
Investigators
Layout table for investigator information
Principal Investigator: Grigory P Arutyunov, Prof Russian Society for Heart Failure

Layout table for additonal information
Responsible Party: Society of Specialists in Heart Failure
ClinicalTrials.gov Identifier: NCT02087332     History of Changes
Other Study ID Numbers: TOR-IIT-001
TOR-IIT-001 ( Other Grant/Funding Number: Investigator Initiated study. Grant was provided by Takeda Pharmaceuticals LLC, Russia )
First Posted: March 14, 2014    Key Record Dates
Last Update Posted: March 20, 2014
Last Verified: March 2014

Keywords provided by Society of Specialists in Heart Failure:
Kidney damage hypertension cardiovascular diseases, congestive heart failure renal function natriuresis natriuresis monitoring

Additional relevant MeSH terms:
Layout table for MeSH terms
Hypertension
Heart Failure
Vascular Diseases
Cardiovascular Diseases
Heart Diseases
Torsemide
Antihypertensive Agents
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action