Heart FailureNCT02751242
Identifying Diuretic Resistance in Patients With Acute Heart Failure
An observational study of Heart Failure, run by Vanderbilt University at 1 site in United States.
Trial summary
The study team hypothesizes patients at risk for diuretic resistance can be identified early in their Emergency Department (ED) or hospital stay by evaluating their urine sodium and potassium concentration after an initial dose of IV loop diuretic. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- Type of treatment
- Injection or infusion
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to 31 Jul 2017
- Phase
- Observational
- 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
Study population: Adult ED patients diagnosed with HF
Who may be able to join
- Adults over age 18
- Diagnosed with AHF in the ED
- Patient or surrogate provided informed consent
Who cannot join
- Systolic Blood pressure < 90 mmHg
- Intravenous diuretic administration prior to enrollment
- Allergy to furosemide and bumetanide
- Currently receiving any form of dialysis
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
The study team hypothesizes patients at risk for diuretic resistance can be identified early in their Emergency Department (ED) or hospital stay by evaluating their urine sodium and potassium concentration after an initial dose of IV loop diuretic. The goal of this pilot study is to prospectively study urinary electrolyte excretion and determine patterns of diuretic responsiveness. This study would be utilized to power an interventional study which aims to study alternative methods of treating patients who are identified as having a poor response to diuretics in the ED and hospital. This would be expected to have a significant impact on a patient's hospital course, length of stay and adverse events.
Read the detailed description
Most patients hospitalized with acute heart failure (AHF) respond to intravenous (IV) loop diuretic therapy, which results in symptom improvement and discharge from the hospital after a 3-5 day stay. However, up to 20% of these patients do not respond to IV loop diuretics, and are found to be "diuretic resistant". The treatment pathway for this cohort of patients is unclear. As a result, they experience significantly longer hospital lengths of stay, consume more healthcare resources, and experience an increased proportion of adverse events. Clinicians currently do not have a reliable method of predicting who will become diuretic resistant. The diagnosis is made after hospitalization, based on poor response to diuretics resulting in escalation of therapy. The standard approach to AHF therapy is to treat all patients with IV loop diuretics, not knowing who will become diuretic resistant. When diuretics are effective in promoting diuresis and natriuresis the urinary sodium rises and the urinary potassium falls. Those patients with continued low urinary sodium despite IV diuretic administration are at risk for developing diuretic resistance. Defining diuretic resistance based on urinary electrolytes before it becomes clinically apparent would facilitate an earlier change in therapy, with an aim of preventing a prolonged hospitalization.
Recently, a method to determine diuretic responsiveness based on measurements of urinary sodium in the first 6 hours after diuretic administration has been reported. This is a novel concept, and suggests the HF provider could identify poor diuretic responsiveness within 1-2 hours of diuretic administration. This study was conducted in the inpatient setting, where subjects were enrolled up to 4 days after admission. Conducting a similar ED-based study at the time of initial diuretic administration would be important to determine if early diuretic responsiveness can also be predicted using their formula for urinary sodium output. The fractional sodium excretion, (FeNa %), represents the amount of sodium excretion (mmol/time) as a percentage of filtered load [plasma sodium concentration to glomerular filtration rate]. FeNa has been used in several studies to assess diuresis in HF patients. Baseline FeNa has been shown to be reduced to less than 1% in patients with HF and a baseline FeNa of less than 0.2% is associated with diuretic resistance. Identifying effective therapies to mitigate diuretic resistance will improve symptoms, decrease hospital length of stay, conserve healthcare resources and possibly improve morbidity and mortality.
Sodium reabsorption is finely tuned in the distal portion of the nephron by the sodium-chloride cotransporter (NCC) in the distal convoluted tubule and the epithelial sodium channel (ENaC) in the collecting duct. Although only 5-10% of filtered urinary sodium typically reaches these portions of the nephron, this represents roughly 15-times the average daily dietary sodium intake. Nearly 100% of sodium is reabsorbed in the setting of sodium depletion, hypovolemia, or certain pathogenic conditions (congestive heart failure, decompensated cirrhosis). The aldosterone-sensitive collecting duct is largely responsible for this fine regulation by its ability to maximally active ENaC-dependent sodium reabsorption. Although ENaC activity and expression can be measured in vitro (patch clamp) and animal studies (micropuncture, Western blot), assessment in clinical studies is very limited due to the inability to access adequate tissue. Therefore, investigators have used the urinary sodium/potassium ratio as an index of ENaC activity. The study team has recently developed a mass spectrometric assay for urinary exosomal epithelial sodium channel (γENaC), demonstrating a 15-fold increase during low sodium diet or during aldosterone administration. This method represents a significant technical advance and provides clinical investigators a tool to measure ENaC expression in future clinical studies. The study team anticipates that a similar approach will enable clinicians to measure the expression of additional relevant transporters and channels.
- Conditions
- Heart Failure
- Keywords
- Diuretic Resistance, Emergency Medicine
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | All patients will receive a dose of intravenous furosemide. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Natriuretic responsiveness
Defined by urine sodium output
Measured: First 6 hours of diuretic administration
Secondary outcomes (1)
Formula to predict natriuretic responsiveness
Na output (mmol) = Estimated Glomerular Filtration Rate (eGFR) x (BSA/1.73) x (Cr serum/Cr urine) x 60 min x 2.5 hours x (Na urine/1000ml)
Measured: 1 and 2 hours after diuretic administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2016 (estimated)
- Study startAug 2016
- Primary completion31 Jul 2017
- Study completion31 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Responsible party
- Principal investigator, Jin H. Han, Vanderbilt University
- Investigators
- Jin Han, MD, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02751242
- Sponsor's protocol ID
- 151931
- Status last verified
- Oct 2017
- First submitted
- 13 Apr 2016
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Diuretic Resistance in Patients With Acute Heart Failure
- ClinicalTrials.gov ID
- NCT02751242
- Acronym / sponsor ID
- 151931
- Conditions
- Heart Failure
- Keywords
- Diuretic Resistance, Emergency Medicine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Study start
- Aug 2016
- Primary completion
- 31 Jul 2017 (actual)
- Study completion
- 31 Jul 2017 (actual)
- First posted
- 26 Apr 2016 (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 study team hypothesizes patients at risk for diuretic resistance can be identified early in their Emergency Department (ED) or hospital stay by evaluating their urine sodium and potassium concentration after an initial dose of IV loop diuretic. The goal of this pilot study is to prospectively study urinary electrolyte excretion and determine patterns of diuretic responsiveness. This study would be utilized to power an interventional study which aims to study alternative methods of treating patients who are identified as having a poor response to diuretics in the ED and hospital. This would be expected to have a significant impact on a patient's hospital course, length of stay and adverse events.
Detailed description
Most patients hospitalized with acute heart failure (AHF) respond to intravenous (IV) loop diuretic therapy, which results in symptom improvement and discharge from the hospital after a 3-5 day stay. However, up to 20% of these patients do not respond to IV loop diuretics, and are found to be "diuretic resistant". The treatment pathway for this cohort of patients is unclear. As a result, they experience significantly longer hospital lengths of stay, consume more healthcare resources, and experience an increased proportion of adverse events. Clinicians currently do not have a reliable method of predicting who will become diuretic resistant. The diagnosis is made after hospitalization, based on poor response to diuretics resulting in escalation of therapy. The standard approach to AHF therapy is to treat all patients with IV loop diuretics, not knowing who will become diuretic resistant. When diuretics are effective in promoting diuresis and natriuresis the urinary sodium rises and the urinary potassium falls. Those patients with continued low urinary sodium despite IV diuretic administration are at risk for developing diuretic resistance. Defining diuretic resistance based on urinary electrolytes before it becomes clinically apparent would facilitate an earlier change in therapy, with an aim of preventing a prolonged hospitalization.
Recently, a method to determine diuretic responsiveness based on measurements of urinary sodium in the first 6 hours after diuretic administration has been reported. This is a novel concept, and suggests the HF provider could identify poor diuretic responsiveness within 1-2 hours of diuretic administration. This study was conducted in the inpatient setting, where subjects were enrolled up to 4 days after admission. Conducting a similar ED-based study at the time of initial diuretic administration would be important to determine if early diuretic responsiveness can also be predicted using their formula for urinary sodium output. The fractional sodium excretion, (FeNa %), represents the amount of sodium excretion (mmol/time) as a percentage of filtered load [plasma sodium concentration to glomerular filtration rate]. FeNa has been used in several studies to assess diuresis in HF patients. Baseline FeNa has been shown to be reduced to less than 1% in patients with HF and a baseline FeNa of less than 0.2% is associated with diuretic resistance. Identifying effective therapies to mitigate diuretic resistance will improve symptoms, decrease hospital length of stay, conserve healthcare resources and possibly improve morbidity and mortality.
Sodium reabsorption is finely tuned in the distal portion of the nephron by the sodium-chloride cotransporter (NCC) in the distal convoluted tubule and the epithelial sodium channel (ENaC) in the collecting duct. Although only 5-10% of filtered urinary sodium typically reaches these portions of the nephron, this represents roughly 15-times the average daily dietary sodium intake. Nearly 100% of sodium is reabsorbed in the setting of sodium depletion, hypovolemia, or certain pathogenic conditions (congestive heart failure, decompensated cirrhosis). The aldosterone-sensitive collecting duct is largely responsible for this fine regulation by its ability to maximally active ENaC-dependent sodium reabsorption. Although ENaC activity and expression can be measured in vitro (patch clamp) and animal studies (micropuncture, Western blot), assessment in clinical studies is very limited due to the inability to access adequate tissue. Therefore, investigators have used the urinary sodium/potassium ratio as an index of ENaC activity. The study team has recently developed a mass spectrometric assay for urinary exosomal epithelial sodium channel (γENaC), demonstrating a 15-fold increase during low sodium diet or during aldosterone administration. This method represents a significant technical advance and provides clinical investigators a tool to measure ENaC expression in future clinical studies. The study team anticipates that a similar approach will enable clinicians to measure the expression of additional relevant transporters and channels.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Usual Care | – | –All patients will receive a dose of intravenous furosemide. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult ED patients diagnosed with HF
Key inclusion criteria (3 listed)
- Adults over age 18
- Diagnosed with AHF in the ED
- Patient or surrogate provided informed consent
Key exclusion criteria (4 listed)
- Systolic Blood pressure < 90 mmHg
- Intravenous diuretic administration prior to enrollment
- Allergy to furosemide and bumetanide
- Currently receiving any form of dialysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Natriuretic responsiveness
Time frame: First 6 hours of diuretic administration
Defined by urine sodium output
1 secondary outcome
Formula to predict natriuretic responsiveness
Time frame: 1 and 2 hours after diuretic administration
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 6 Nov 2017.
- Individual participant dataSharing planned: No
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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.
Jin Han, MD principal investigator
Vanderbilt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Vanderbilt University 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 4 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 6 Nov 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 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.
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?
Natriuretic responsiveness (time frame: First 6 hours of diuretic administration). 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 6 Nov 2017.