Heart failure patients with muscular dystrophy who showed brain natriuretic peptide (BNP) of 100 pg/mL or more in spite of myocardial protection treatment
Conditions
Interventions
Tranilast 300 mg/day is administered three times per day as the study treatment. The start date of study treatment is defined as the medication start date, and 28 weeks of study treatment will be per
Sponsors
National Hospital Organization Toneyama National Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) MD patients aged 13 or more 2) With high value in BNP (100 pg/mL or more) 3) Those introduced with standard myocardium protective drugs (angiotensin converting enzyme inhibitor (ACEI)/angiotensin type II receptor blocker (ARB) and/or beta blocker) who meets both of the following: taking maintenance doses at the time of consent; whose dosage regimen and doses are fixed from 2 weeks before the start of administration until the start of administration. 4) To whom intrinsic administration of capsule, fine granules or dry syrup is possible, or who can be reliably administered tranilast by tube 5) Provided written consent by their free will/the representative
Exclusion criteria
Exclusion criteria: 1) Acute stage heart failure condition (using cardiotonic, diuretic, antiarrhythmic drug intravenously) 2) From 2 weeks before the start of administration to the start of administration Directions of digitalis, diuretic, aldosterone antagonist, cardiotonic agent, antiarrhythmic drug are not fixed 3) With a lethal arrhythmia including ventricular premature contraction of more than four (short run)), excluding those with transplanted implantable defibrillators 4) With serious renal dysfunction (estimated glomerular filtration ratio (eGFR) using cystatin C of less than 30 mL/min/1.73 m2) Male: eGFR = (104 ^ Cystatin C-1.019^ 0.996age (years)) - 8 Female: eGFR = (104 ^ Cystatin C-1.019 ^ 0.996age (years) ^ 0.929) - 8 For those aged 18 or less, cyctain C of 2.5 mg/L or more is used. 5) With severe liver function disorder (T. Bil of 10 mg/dl or more, AST and ALT of 500 IU/L or more, ALP of 5 times or more of the normal upper limit, PT of 40% or less, bleeding tendency, hepatic failure symptoms (fulminant hepatitis), cirrhosis of the liver, liver tumor, jaundice prolonged for more than 6 months) (equivalent to grade 3 in "Classification criteria for severity of adverse drug reactions" ) 6) Marked white blood cell (WBC) decrease (less than 3000/mm^3), platelet (Plt) decrease (less than 80,000/mm^3) 7) Having a history of hypersensitivity to tranilast 8) Pregnant or possibly pregnant 9) For whom the principal investigator/sub-investigators judged not appropriate for participation in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in BNP before the start of administration (using the average of values in the pre-treatment observation period and at the start of administration) to 24 weeks (using the average of values at 20 weeks, 24 weeks and 28 weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Cardiac events (change of oral medicine for cardiac failure due to cardiac function exacerbation (ACEI/ARB, Beta blocker, digitalis, diuretic, aldosterone antagonist, cardiotonic agent or antiarrhythmic agent), administration of intravenous drugs (cardiotonic agents, diuretics or antiarrhythmic agent), hospitalization due to heart failure or prolongation of hospitalization) 2) All deaths 3) Left ventricula fractional shortening (FS) 4) Human atrial natriuretic peptide (hANP), cardiac troponin T (cTnT) 5) The expression of transient receptor potential cation channel, subfamily V, member 2 (TRPV2) expression on cytoplasminc membrane of isolated peripheral blood mononuclear cells (PBMCs) 6) Hand finger muscle strength (pinch strength), creatine kinase (CK) 7) Muscular dystrophy quality of life-60 (MDQOL-60), The short form (12) health survey (SF-12) 8) Adverse events | — |
Countries
Japan
Contacts
Public ContactYutaka Ito
National Hospital Organization Nagoya Medical Center Clinical Research Center
Outcome results
None listed