Outcome and Treatment Quality Study of Tolvaptan to Treat Hyponatremia in Patients With Heart Failure

NCT02352285 | Terminated Phase 4

• 1 other identifier: 156-KOB-1201i
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

The objective is to evaluate the efficacy and safety on the tolvaptan for increasing serum Na levels in patients with worsening heart failure and hyponatremia.

Conditions

Heart Failure With Hyponatremia

Outcome Measures

Primary Outcomes (1)

• Average daily AUC of change from baseline in serum Na level to day 4 within the double-blind treatment period

  from baseline to day 4

Secondary Outcomes (2)

• Average amount of furosemide used during hospitalization.

  from day 1 to discharge date (up to subject condition day 2 ~ day 30)

• Average amount of furosemide used during out-patient period.

  from baseline to day 30 and day 60

Study Arms (2)

Tolvaptan

EXPERIMENTAL

Tovaptan tablet 15mg, 30mg, 60mg, once a day, oral

Drug: Tolvaptan

placebo

PLACEBO COMPARATOR

placebo tablet 15mg, 30mg, 60mg, once a day, oral

Drug: Placebo

Interventions

Tolvaptan DRUG

Start with 15mg to titrate upwards to 30mg to 60mg, once a daily

Also known as: Samsca

Tolvaptan

Placebo DRUG

Start with 15mg to titrate upwards to 30mg to 60mg, once a daily

placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients hospitalized due to heart failure with clinically significant hyponatremia (except hypovolemic) (defined as serum Na \< 125 mEq/L or less marked hyponatremia that is symptomatic and has resisted correction with fluid restriction) prior to randomization.
• Male and female patients aged ≥ 20 years.
• New York Heart Association (NYHA) class III/Ⅳ
• Signs of extracellular volume expansion, defined as two or more of the following: JVD, peripheral edema, dyspnea or pulmonary congestion.
• B-type natriuretic peptide (BNP) ≥ 150 pg/mL or N terminal (NT)-proBNP ≥ 450 pg/mL.

You may not qualify if:

• Women who are pregnant, breast feeding, or of childbearing potential who are not using acceptable contraceptive methods
• Patients with hyponatremia in hypovolemic states, defined as the presence of clinical and historical evidence of extracellular fluid volume depletion
• Patients unable to sense or respond to thirst.
• Patients who are likely to require prolonged hospitalization for reasons other than chronic heart failure (CHF)
• Patients with recent prior treatment for hyponatremia
• Patients with severe hyponatremia symptoms requiring immediate intervention with hypertonic saline
• Patients with causes of neurological symptoms, which are attributable to psychological (psychoses), structural (dementia of the Alzheimer's type, post-infarct dementia) or other metabolic causes
• Patients with acute and transient hyponatremia associated with head trauma or severe neurological injury
• Patients with a history of hyponatremia known to be due to severe, untreated hypothyroidism/adrenal insufficiency.
• Patients with psychogenic polydipsia.
• Patients with systolic BP \< 90 mmHg at screening.
• Patients with a history of hypersensitivity and/or idiosyncratic reaction to benzazepine or benzazepine derivatives (such as benazepril), or tolvaptan.
• Patients with a history of drug or medication abuse within the 3 months prior to screening, or current alcohol abuse.
• Patients with uncontrolled diabetes mellitus
• Patients with a current urinary tract obstruction

Sponsors & Collaborators

• Korea Otsuka Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Seoul National University Bundang Hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

Tolvaptan

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Dongju Choi, MD

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2012
• First Posted: February 2, 2015
• Study Start: December 1, 2012
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: June 14, 2017

Record last verified: 2016-11

Locations

KR (1)