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

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 - 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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000012716

Enrollment

100

Registered

2013-12-27

Start date

2013-12-26

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute exacerbation of chronic heart failure

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

Exclusion criteria: 1 Patients with a history of hypersensitivity for an ingredient of tolvaptan or analogues such as Mozavaptan. 2 Patients with lowering consciousness. 3 Patients who need treatment with respirator. 4 Patients who receive artificial dialysis. 5 Patients with anuria. 6 Patients with severe liver disfunction. 7 Patients who cannot feel thirst or are difficult to intake the fluid. 8 Patients with hypernatremia. 9 Female patients who are pregnant, possibly pregnant, or lactating, or who plan to become pregnant. 10 Patients otherwise judged by the investigator or sub-investigator to be inappropriate for inclusion in the study.

Design outcomes

Primary

Measure	Time frame
Body weight change from baseline to day7	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Japan

Contacts

Public ContactAtsushi Sueyoshi

UJI-TOKUSHUKAI MEDICAL CENTER Cardiovascular Medicine

rinri@ujitoku.or.jp0774-20-1111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026