Acute Decompensated Heart FailurePhase 4TUFNCT01863511
Tolvaptan/Ultrafiltration in the Treatment of Acute Heart Failure
A Phase 4 study testing loop diuretic, tolvaptan and ultrafiltration in people with Acute Decompensated Heart Failure, run by The Christ Hospital at 1 site in United States.
Trial summary
For patients hospitalized with acute decompensated heart failure,volume removal remains the primary therapeutic objective. The current standard of care remains loop diuretics.The high likelihood of readmissions and poor outcomes highlights the need to examine and improve in-hospital protocols for these patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Decompensated Heart Failure
- What is being tested?
- loop diuretic, tolvaptan and ultrafiltration
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Dec 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 2 of 3 physical exam findings of volume overload (rales, JVP over 5 cm and edema)
- BNP over 300
- no contraindication to ultrafiltration (line insertion, heparin use)
Who cannot join
- serum creatinine > 3mg/dL or Na > 145
- inotrope or vasopressor dependency
- active infection, including urinary tract
- resynchronization therapy or coronary intervention in past 30 days
- life expectancy less than 6 months
- hypertrophic obstructive cardiomyopathy with peak resting gradient > 20 mmHg
- IV contrast or NSAID use in the past 1 week (uNGAL related requirement)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Primary Mode of Therapy in Acute Decompensated Heart Failure:Comparison Between Usual Care Plus Tolvaptan and Ultrafiltration.
For patients hospitalized with acute decompensated heart failure,volume removal remains the primary therapeutic objective. The current standard of care remains loop diuretics.The high likelihood of readmissions and poor outcomes highlights the need to examine and improve in-hospital protocols for these patients. Ultrafiltration allows for greater volume removal, less neurohormonal stimulation and greater sodium removal.However it is associated with increased costs, line complications, and relative immobility during treatment. Tolvaptan in addition to diuretic therapy has been shown to improve the amount of volume removed compared to diuretic alone.
The study proposes to compare the strategy of adding tolvaptan to usual care with ultrafiltration as primary mode of therapy in acute decompensated HF(ADHF) patients.
Read more
Hypothesis: addition of tolvaptan to usual care for hospitalized HF patients will result in:
- greater volume and weight reduction compared with usual care
- similar efficacy outcomes compared with ultrafiltration, with less complications of therapy
Read the detailed description
Study design is a prospective randomized open labeled and unblinded comparison of two different approaches to volume removal. Enrolled patients will be evaluated for target weight to be removed. Patients will be randomized to usual care (UC), usual care plus tolvaptan (UC+T) or ultrafiltration (UF), within 12 hours of presentation.
Treatment in the UC and UC+T arms will begin with a furosemide bolus(double the home dose or if unavailable, 60mg) and continue with a drip(10 or 20 mg/hr). In addition the UC+T group will be treated with tolvaptan 30 mg orally once daily.
Patients in the UF arm will be treated with UF administered through a brachial line or a catheter in the internal jugular vein. Loop and thiazide diuretics will be discontinued, although aldosterole antagonists will be continued.
Urinary neutrophil gelatinase associated lipocalcin(uNGAL)levels are elevated in renal dysfunction and may be a sensitive biomarker to distinguish between intrinsic renal damage and reversible, transient prerenal azotemia.Characterizing the changes in uNGAL levels during the course of ADHF therapy, in comparison with patient weight, BUN and creatinine levels is an important step in establishing the role of this potential promising biomarker in ADHF treatment strategies.
Protocol highlights for all patients include:
Baseline labs and daily through day 4 and at discharge(BMP, BNP, CBC, urine creatinine and sodium, uNGAL)
- Daily am weights
- Daily volume status:total intake, urine output, ultrafiltrate volume
- Collect all urine and ultrafiltrate in a 24 hour collection bag, record volume, creatinine and Na levels
- length of stay
- hospital day 4: Minnesota Living with Heart Failure questionnaire
- Cost of hospitalization
- Conditions
- Acute Decompensated Heart Failure
- Being tested
- loop diuretic, tolvaptan, ultrafiltration
- Keywords
- Treatment options for acute decompensated heart failure, Ultrafiltration, tolvaptan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
loop diureticDrug
tolvaptanDrug
ultrafiltrationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| usual care | Active comparator | IV loop diuretics Receives: Drug: loop diuretic |
| Usual care plus tolvaptan | Active comparator | IV loop diuretic plus Tolvaptan 30 mg orally once daily Receives: Drug: loop diuretic; Drug: tolvaptan |
| ultrafiltration | Active comparator | Volume removal through a brachial line extended length catheter or a quad lumen catheter via the internal jugular vein Receives: Procedure: ultrafiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Net change in weight
Measured: day 1,2,3,4,5
Secondary outcomes (9)
net volume loss
Measured: day 1,2,3,4,5
urinary NGAL
Measured: Day 1,2,3,4,5
dyspnea score
Measured: baseline and day 5
BNP change from admission to discharge
Measured: baseline and day 5
serum creatinine change
Measured: Day 1,2,3,4,5
serum sodium and potassium changes
Measured: baseline through day 5
Quality of Life
Measured: day 4 of hospital stay
all cause readmission
Measured: 30 day
all cause death
Measured: 30 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2013 (estimated)
- Study startMay 2013
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Decompensated Heart FailureStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Christ Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Eugene Chung, The Christ Hospital
- Investigators
- Eugene S Chung, MD, Principal investigator, The Christ Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01863511
- Sponsor's protocol ID
- TUF-01
- Acronym
- TUF
- Status last verified
- Feb 2015
- First submitted
- 20 May 2013
- Last updated
- 28 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Srivastava M, Harrison N, Caetano AFS, Tan AR, Law M. Ultrafiltration for acute heart failure. Cochrane Database Syst Rev. 2022 Jan 21;1(1):CD013593. doi: 10.1002/14651858.CD013593.pub2.
PubMed 35061249
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Mode of Therapy in Acute Decompensated Heart Failure:Comparison Between Usual Care Plus Tolvaptan and Ultrafiltration.
- ClinicalTrials.gov ID
- NCT01863511
- Acronym / sponsor ID
- TUF / TUF-01
- Conditions
- Acute Decompensated Heart Failure
- Keywords
- Treatment options for acute decompensated heart failure, Ultrafiltration, tolvaptan
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- The Christ HospitalUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 29 May 2013 (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.
For patients hospitalized with acute decompensated heart failure,volume removal remains the primary therapeutic objective. The current standard of care remains loop diuretics.The high likelihood of readmissions and poor outcomes highlights the need to examine and improve in-hospital protocols for these patients. Ultrafiltration allows for greater volume removal, less neurohormonal stimulation and greater sodium removal.However it is associated with increased costs, line complications, and relative immobility during treatment. Tolvaptan in addition to diuretic therapy has been shown to improve the amount of volume removed compared to diuretic alone.
The study proposes to compare the strategy of adding tolvaptan to usual care with ultrafiltration as primary mode of therapy in acute decompensated HF(ADHF) patients.
Hypothesis: addition of tolvaptan to usual care for hospitalized HF patients will result in:
- greater volume and weight reduction compared with usual care
- similar efficacy outcomes compared with ultrafiltration, with less complications of therapy
Detailed description
Study design is a prospective randomized open labeled and unblinded comparison of two different approaches to volume removal. Enrolled patients will be evaluated for target weight to be removed. Patients will be randomized to usual care (UC), usual care plus tolvaptan (UC+T) or ultrafiltration (UF), within 12 hours of presentation.
Treatment in the UC and UC+T arms will begin with a furosemide bolus(double the home dose or if unavailable, 60mg) and continue with a drip(10 or 20 mg/hr). In addition the UC+T group will be treated with tolvaptan 30 mg orally once daily.
Patients in the UF arm will be treated with UF administered through a brachial line or a catheter in the internal jugular vein. Loop and thiazide diuretics will be discontinued, although aldosterole antagonists will be continued.
Urinary neutrophil gelatinase associated lipocalcin(uNGAL)levels are elevated in renal dysfunction and may be a sensitive biomarker to distinguish between intrinsic renal damage and reversible, transient prerenal azotemia.Characterizing the changes in uNGAL levels during the course of ADHF therapy, in comparison with patient weight, BUN and creatinine levels is an important step in establishing the role of this potential promising biomarker in ADHF treatment strategies.
Protocol highlights for all patients include:
Baseline labs and daily through day 4 and at discharge(BMP, BNP, CBC, urine creatinine and sodium, uNGAL)
- Daily am weights
- Daily volume status:total intake, urine output, ultrafiltrate volume
- Collect all urine and ultrafiltrate in a 24 hour collection bag, record volume, creatinine and Na levels
- length of stay
- hospital day 4: Minnesota Living with Heart Failure questionnaire
- Cost of hospitalization
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| usual care | Active comparator | Drug: loop diureticIV loop diuretics |
| Usual care plus tolvaptan | Active comparator | Drug: loop diuretic, Drug: tolvaptanIV loop diuretic plus Tolvaptan 30 mg orally once daily |
| ultrafiltration | Active comparator | Procedure: ultrafiltrationVolume removal through a brachial line extended length catheter or a quad lumen catheter via the internal jugular vein |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 2 of 3 physical exam findings of volume overload (rales, JVP over 5 cm and edema)
- BNP over 300
- no contraindication to ultrafiltration (line insertion, heparin use)
Key exclusion criteria (7 listed)
- serum creatinine > 3mg/dL or Na > 145
- inotrope or vasopressor dependency
- active infection, including urinary tract
- resynchronization therapy or coronary intervention in past 30 days
- life expectancy less than 6 months
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 |
|---|---|---|
| loop diuretic | Drug | Usual care plus tolvaptan, usual care |
| tolvaptan | Drug | Usual care plus tolvaptan |
| ultrafiltration | Procedure or surgery | ultrafiltration |
Primary outcome
Net change in weight
Time frame: day 1,2,3,4,5
9 secondary outcomes
net volume loss
Time frame: day 1,2,3,4,5
urinary NGAL
Time frame: Day 1,2,3,4,5
dyspnea score
Time frame: baseline and day 5
BNP change from admission to discharge
Time frame: baseline and day 5
serum creatinine change
Time frame: Day 1,2,3,4,5
serum sodium and potassium changes
Time frame: baseline through day 5
Quality of Life
Time frame: day 4 of hospital stay
all cause readmission
Time frame: 30 day
all cause death
Time frame: 30 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2016.
- Derived from this study: PubMed 35061249Srivastava M, Harrison N, Caetano AFS, Tan AR, Law M. Ultrafiltration for acute heart failure. Cochrane Database Syst Rev. 2022 Jan 21;1(1):CD013593. doi: 10.1002/14651858.CD013593.pub2.
Related trials for Acute Decompensated Heart Failure
Not yet recruitingPhase 3
Early Discharge With Subcutaneous Furosemide Versus Standard Care in Acute Heart Failure
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Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
RecruitingPhase 3
Effects of Continued Administration of Empagliflozin in Patients With Heart Failure on Active SGLT2 Inhibitor Treatment Admitted for Acute Decompensated Heart Failure
Acute Decompensated Heart Failure (ADHF)
Recruiting
Low Level Tragus Stimulation in Acute Decompensated Heart Failure
Acute Decompensated Heart Failure
Recruiting
Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve System (FASTR-II) (IDE-G210258)
Acute Decompensated Heart Failure
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.
Eugene S Chung, MD principal investigator
The Christ 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 loop diuretic, tolvaptan and ultrafiltration in people with Acute Decompensated Heart Failure, run by The Christ Hospital at 1 site in United States.
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 3 inclusion and 7 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: finished, as of the sponsor's last update on 28 Jan 2016. 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 United States. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Net change in weight (time frame: day 1,2,3,4,5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01863511, which also lists 1 linked publication.
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 28 Jan 2016.