Answering question on tolvaptan's efficacy for patients with acute decompensated heart failure and renal failure: AQUAMARINE Study

Answering question on tolvaptan's efficacy for patients with acute decompensated heart failure and renal failure: AQUAMARINE Study - AQUAMARINE

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007109

Enrollment

220

Registered

2012-01-23

Start date

2012-01-01

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 decompensated heart failure

Interventions

Tolvaptan Group : Tolvaptan 15mg orally + Furosemide i.v at least 20mg longer that 2 days Furosemide i.v at least 20mg longer that 2 days

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Patients with fluid retention in congestive heart failure (2) Patients who were hospitalized for acute exacerbation of chronic heart failure (3) glomerular fi ltration rate [eGFR] of 15&#8211;60 mL/min/1&#8226;73 m&#178;, (4) Aged 85 years or younger

Exclusion criteria

Exclusion criteria: (1) Patients with circulatory assist device (2) Patients with consciousness disturbance (3) Hypernatremia (serum Na>147mEq/L) (4) Patients with dehydration (5) Insensitivity to the thirst or difficult for the water intake (6) Severe hypotension or cardiogenic shock (7) Patients are considered undesirable rapid decrease in blood flow circulation (8) Patietns with hypersensitivity to study drug (9) Anuric patients (10) Pregnant woman, lactational woman, patients may be willing to be pregnant or are pregnant (11) In addition, patients were judged as inadequate by physician (12) Acute myocardial infarction

Design outcomes

Primary

Measure	Time frame
A cumulative urine volume (for 48 hours)	—

Secondary

Measure	Time frame
AKI, Cumulative Urine Volume (1-12 hours),additional diuretics dose, serum BUN, serum Cr, eGFR, BNP, serum Na, serum K, NYHA classification, Dyspnea (rational symptom), Improvement in signs of heart failure, (rales, edema, gallop rhythm) , Duration of hospital stays Subgroup analysis: Gender, LVEF >=50%, eGFR<60, eGFR<30, BUN>median value, BUN/Cr>median value, SBP>140, SBP<100, Age >=75 years, prescribed furosemide more than 20mg, ischemic etiology, atrial fibrillation	—

Measure

Time frame

AKI, Cumulative Urine Volume (1-12 hours),additional diuretics dose, serum BUN, serum Cr, eGFR, BNP, serum Na, serum K, NYHA classification, Dyspnea (rational symptom), Improvement in signs of heart failure, (rales, edema, gallop rhythm) , Duration of hospital stays Subgroup analysis: Gender, LVEF >=50%, eGFR<60, eGFR<30, BUN>median value, BUN/Cr>median value, SBP>140, SBP<100, Age >=75 years, prescribed furosemide more than 20mg, ischemic etiology, atrial fibrillation

—

Countries

Japan

Contacts

Public ContactYuya Matsue

Kameda Medical Center Department of Cardiology

yuya8950@gmail.com(047)-092-2211

Outcome results

None listed

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

Answering question on tolvaptan&#39;s efficacy for patients with acute decompensated heart failure and renal failure: AQUAMARINE Study