Clinical efficacy and safety of the ealry intervention with Tolvaptan(V2 receptorinhibiter)in hospitalized patients with acute exacerbation of chronic heart failur: a randomized open-labeled parallel controlled study

Authors
Category Primary study
Registry of TrialsUMIN Clinical Trials Registry
Year 2013
INTERVENTION: Oral administration of 7.5mg to 15mg/day tolvaptan is started at the next day of admission and kept for 7 days, as an additional treatment to conventional therapy.The administration doses of any othre oral diuretics at admission are kept to discharge. Doses of oral loop diuretics are increased in need from the next day of admission for 7 days.The administration doses of any other oral diuretics are kept from admission to discharge. CONDITION: Acute exacerbation of chronic heart failure PRIMARY OUTCOME: Body weight change from baseline to day7 SECONDARY OUTCOME: 1 Average urine volumes of 3 days from day1 to day3; 2 Differences of chest radiographic findings between baseline and day3,day7.; 3 Changes of congestive heart failure symptoms from baseline : Dyspnea,JVD,Hepatic edema,Lower limb edema.; 4 Changes of serum and urinary electrolyte concentration.; Na,K,Cl,Ca,Mg.; 5 Changes of vital sign ; Blood pressure,Heart rate; 6 Endocrine factors:Plasma renin activity,plasma aldosterone,urinary adorenalin,urinary noadorenalin,urinary dopamine; 7 Serum creatinine; 8 Loop Diuretics dose at discharge; 9 Total amount of loop diuretic dose in the hospital; 10 Occurrence of cardiovascular events and rehospitalization due to exacerbation of chronic heart failur in 6months after discharge; 11 Adverse events in the hospital and 6months after discharge INCLUSION CRITERIA: 1 Patients with acute exacerbation of chronic heart failure. 2 Patients aged between 20 and 85 at giving the informed consent. 3 Patients who received loop diuretics (20mg/day or more of Frosemide,30mg/day or more of Azosemide,4mg/day or more of Torasemide.) 4 Patients with more than one of following congestive symptoms; dyspnea,pulmonary congestion,juglar venous distention,lower limb edema. 5 Patients who can receive drugs orally. 6 Patients with less than 3mg/dL of serum creatinine. 7 Patients who gave the infoemed consent to participate in the study of their own free will.
Epistemonikos ID: 293f0991385d8e204323fa6abfcda28e5bbbdaf1
First added on: Aug 22, 2024