Heart Failure With HyponatremiaPhase 4AQUATICNCT02352285
Outcome and Treatment Quality Study of Tolvaptan to Treat Hyponatremia in Patients With Heart Failure
A Phase 4 study testing Tolvaptan in people with Heart Failure With Hyponatremia, run by Korea Otsuka Pharmaceutical Co., Ltd. at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Heart Failure With Hyponatremia
- What is being tested?
- Tolvaptan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2012to Jan 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
- Anuric patients.
- Patients with a serum creatinine > 3.5 mg/dL at screening.
- Terminally ill patients or patients with a moribund condition who have little chance of short-term survival.
- Patients whose hyponatremia is the result of any medication that cannot safely be withdrawn, such as anti-convulsants and anti psychotics
- Patients receiving desmopressin within 2 days of screening.
- Patients who have participated in another investigational drug trial within the past 30 days.
- Any patient who, in the opinion of the investigator, would not be able to comply with the study drug administration or study procedures, or whose overall medical condition would prohibit their participation in the study.
- Patients treated and/or to be treated with strong cytochrome P450 (CYP) 3A inhibitors
- Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose- galactose malabsorption.
- Patients with a AST or ALT > ULN 2.5 or total bilirubin > 2mg/dL
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Clinical Outcome and Treatment Quality Under Adequate Use of Tolvaptan In Correction of Hyponatremia in Patients Hospitalized With Worsening Heart Failure and Hyponatremia
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.
Read the detailed description
This is a phase 4, multicenter, randomized, double-blind, placebo-controlled, parallel-group interventional study comparing tolvaptan (15 to 60 mg) to placebo in adult patients hospitalized (or admission to emergency room) due to worsening of heart failure and dilutional hyponatremia. All patients will be on standard therapy for heart failure.
- Conditions
- Heart Failure With Hyponatremia
- Being tested
- Tolvaptan, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TolvaptanDrug
Also called Samsca
Start with 15mg to titrate upwards to 30mg to 60mg, once a daily
PlaceboDrug
Start with 15mg to titrate upwards to 30mg to 60mg, once a daily
| Study group | Role | What they receive |
|---|---|---|
| Tolvaptan | Experimental | Tovaptan tablet 15mg, 30mg, 60mg, once a day, oral Receives: Drug: Tolvaptan |
| placebo | Placebo comparator | placebo tablet 15mg, 30mg, 60mg, once a day, oral Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average daily AUC of change from baseline in serum Na level to day 4 within the double-blind treatment period
Measured: from baseline to day 4
Secondary outcomes (2)
Average amount of furosemide used during hospitalization.
Measured: from day 1 to discharge date (up to subject condition day 2 ~ day 30)
Average amount of furosemide used during out-patient period.
Measured: from baseline to day 30 and day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2015 (estimated)
- Study startDec 2012
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With HyponatremiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dongju Choi, MD, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02352285
- Sponsor's protocol ID
- 156-KOB-1201i
- Acronym
- AQUATIC
- Status last verified
- Nov 2016
- First submitted
- 20 Dec 2012
- Last updated
- 14 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Clinical Outcome and Treatment Quality Under Adequate Use of Tolvaptan In Correction of Hyponatremia in Patients Hospitalized With Worsening Heart Failure and Hyponatremia
- ClinicalTrials.gov ID
- NCT02352285
- Acronym / sponsor ID
- AQUATIC / 156-KOB-1201i
- Conditions
- Heart Failure With Hyponatremia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2012 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 2 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a phase 4, multicenter, randomized, double-blind, placebo-controlled, parallel-group interventional study comparing tolvaptan (15 to 60 mg) to placebo in adult patients hospitalized (or admission to emergency room) due to worsening of heart failure and dilutional hyponatremia. All patients will be on standard therapy for heart failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tolvaptan | Experimental | Drug: TolvaptanTovaptan tablet 15mg, 30mg, 60mg, once a day, oral |
| placebo | Placebo comparator | Drug: Placeboplacebo tablet 15mg, 30mg, 60mg, once a day, oral |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (25 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TolvaptanAlso: SamscaStart with 15mg to titrate upwards to 30mg to 60mg, once a daily | Drug | Tolvaptan |
| PlaceboStart with 15mg to titrate upwards to 30mg to 60mg, once a daily | Drug | placebo |
Primary outcome
Average daily AUC of change from baseline in serum Na level to day 4 within the double-blind treatment period
Time frame: from baseline to day 4
2 secondary outcomes
Average amount of furosemide used during hospitalization.
Time frame: from day 1 to discharge date (up to subject condition day 2 ~ day 30)
Average amount of furosemide used during out-patient period.
Time frame: from baseline to day 30 and day 60
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2017.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dongju Choi, MD principal investigator
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tolvaptan in people with Heart Failure With Hyponatremia, run by Korea Otsuka Pharmaceutical Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average daily AUC of change from baseline in serum Na level to day 4 within the double-blind treatment period (time frame: from baseline to day 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2017.