Heart FailurePhase 4NCT03187509
Weight-Based Torsemide Dosing in Subjects With Heart Failure
A Phase 4 study testing Torsemide and Standard Outpatient Heart Failure Management in people with Heart Failure, run by New York City Health and Hospitals Corporation at 1 site in United States.
Trial summary
This study will be a randomized open-label pilot study. The purpose of the study is to compare standard of care outpatient heart failure management versus a weight based torsemide regimen. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- What is being tested?
- Torsemide and Standard Outpatient Heart Failure Management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Apr 2018to 14 Mar 2022
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All subjects with admission diagnosis of heart failure, including heart failure with reduced ejection fraction (HFrEF) or preserved ejection fraction (HFpEF) treated with loop diuretics during hospitalization
- Must be at least 18 years old at time of enrollment
- Must have reliable access to a telephone, and be able to speak and understand English or Spanish over a telephone connection
Who cannot join
- Any subject who is currently pregnant
- Any subject with end-stage renal disease requiring hemodialysis
- Any subject with serum potassium concentration < 3.5 mEq/L at discharge
- Any subject with serum magnesium concentration < 1.4 mg/dL at discharge
- Any subject with a known history of allergic reaction to loop diuretics
- Any subject with known severe stenotic valvular heart disease
Show all 9Show fewer
- Any subject who requires chronic inotropic pharmacotherapy
- Any subject undergoing evaluation for cardiac transplantation or left-ventricular assist device
- Any subject who is not able to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Weight-Based Torsemide Dosing vs. Standard Outpatient Management in Subjects With Heart Failure: A Randomized Open-Label Pilot Study
This study will be a randomized open-label pilot study. The purpose of the study is to compare standard of care outpatient heart failure management versus a weight based torsemide regimen. Subjects admitted to the hospital for heart failure exacerbation will be randomized upon discharge to either standard of care outpatient heart failure management or a weight based torsemide regimen. Those subjects randomized to standard of care therapy will be prescribed a daily fixed dose of a loop diuretic at hospital discharge and have a follow-up appointment within one week of discharge. All management decisions including loop diuretic type, dose and frequency will be made at the discretion of the subject's personal physician. Those randomized to an individualized weight based torsemide regimen will be prescribed a dose of torsemide upon hospital discharge based on a prespecified algorithm. These subjects will then undergo physician-subject phone encounters three times a week where the subject's torsemide dose will be modified based on the prespecified algorithm which incorporates current symptoms and weight. Primary end-point will be an unbiased estimate of 30-day all cause readmission rates. Secondary end-points include incidence of acute kidney injury, changes in brain natriuretic peptide levels from baseline and a preliminary estimate of the effect size and feasibility of a weight-based torsemide regimen intervention in order to plan a future larger study.
Read the detailed description
This study will be an open-label parallel randomized pilot study comparing an individualized weight-based torsemide dosing regimen vs. standard outpatient management in patients with a diagnosis of heart failure.The study will include consenting subjects who are admitted to Jacobi Medical Center with heart failure and were treated with loop diuretic therapy during hospitalization. Prior to discharge, these subjects will be randomized to one of two groups, either an individualized weight-based torsemide regimen group vs. a standard heart failure management group.
After randomization, all subjects will undergo an initial assessment prior to discharge. All subjects will be examined, weighed and assigned a composite congestion score (CCS). CCS is a measurement of current fluid status that has been shown to correlate with clinical outcomes in heart failure patients (19). It assesses a patient's signs and symptoms of congestion, including dyspnea, orthopnea, fatigue, jugular venous distention, rales and peripheral edema. Each category is given a score from 0-3, 0=none, 1=mild,2=moderate and 3=severe. Each subject is given a final composite score for their current volume status.
After discharge, those randomized to standard care will receive standard heart failure care as currently provided in our institution. This routinely includes, but is not limited to, an appointment with their primary care physician within one week of discharge, nutrition consultation, and social work evaluation with support services provided as determined by the social worker. At discharge, all heart failure medication changes including diuretic type, dose and frequency, as well as further management decisions, will be left to the discretion of the subject and the subject's doctors. Those who will be randomized to the individualized weight-based torsemide regimen will be given a standup home scale and torsemide 20mg tabs in a bottle with 100 tablets.
An initial torsemide dose will be assigned based on the patient's GFR and CCS at discharge. These subjects will then have a phone encounter with a physician three times a week where subjects will be instructed to modify the torsemide dose based on their current weight. Patients will be instructed to weigh themselves at the same time of the day, postvoid, prior to eating, prior to the medication dose, and while wearing the same clothing for consistency. The scales should stand on a flat, solid surface rather than carpets unless specifically designed for use in that setting. All phone call encounters and loop diuretic changes will be based on the pre-specified algorithm. These subjects will also receive all the same care and support as a standard subject, including the primary care appointment in one week and other support services, except with instructions to the subject and provider to follow the loop diuretic recommendations from this protocol. Subjects who have been instructed to take more than 80 torsemide 20mg tablets will receive a delivery of 100 additional torsemide 20mg tablets.
All subjects in the study will have follow up visit at week 5 from discharge date. Total diuretic use during the study period will be assessed and current symptoms/quality of life will be evaluated using the Kansas City Cardiomyopathy Questionnaire. The patient will receive a physical examination including a final weight and calculation of composite congestion score. Serum B-type natriuretic peptide (BNP) will be obtained as well as a basic metabolic panel and serum magnesium level to assess for electrolyte disturbances and changes in kidney function. Intervention group subjects will have a count of the remaining number of torsemide tablets in the bottle of torsemide given to them at discharge. Compliance with the algorithm will be assessed by comparing the number of remaining tablets with the number of tablets prescribed during the study. Subjects whose follow-up visit occurs over 45 days after the date of hospital discharge for the enrollment hospitalization shall be deemed to be late for follow-up. Acute kidney injury (AKI) will be defined as an increase in serum creatinine concentration of 0.3 at the five-week follow-up visit compared to the final serum creatinine level measured during hospitalization. Adherence will be measured by comparing the number of tablets in the subject's torsemide supply to the number of expected tablets in the torsemide supply. Adherence will be defined as a tablet count consistent with the subject having taken 88% or more of the expected torsemide tablets
- Conditions
- Heart Failure
- Being tested
- Torsemide, Standard Outpatient Heart Failure Management
- Keywords
- Torsemide, loop diuretics, weight-based
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TorsemideDrug
Also called Demadex
These subjects who are randomized to a weight-based torsemide regimen will be instructed via phone encounters three times per week to take an individualized dose of torsemide based on their current weight and symptoms. These subjects will have a follow-up study appointment at week 5 for a final weight and blood work to assess kidney function, electrolytes and brain-natriuretic peptide levels.
Standard Outpatient Heart Failure ManagementOther
Those subjects randomized to standard outpatient management group will be prescribed a daily fixed dose of a loop diuretic upon discharge from the hospital. These subjects will have a follow-up appointment within one week of discharge where all medications including loop diuretic type, dose and frequency will be managed at the discretion of the subject's physician. These subjects will also have a follow-up study appointment at week 5 for a final weight and blood work to assess kidney function, electrolytes and brain-natriuretic peptide levels.
| Study group | Role | What they receive |
|---|---|---|
| Weight-Based Torsemide Group | Experimental | Subjects will be randomized to complete a weight-based torsemide dosing regimen for their outpatient heart failure management. These subjects will prescribed a specified dose of torsemide on discharge from the hospital and subsequently have a phone encounter with a physician three times a week where their dose of torsemide will be titrated based on an algorithm which factors in current symptoms and weight. Study subjects will have a final follow-up appointment at the completion of the study to evaluate current symptoms, weight and perform blood work to assess kidney function, electrolytes and brain natriuretic peptide levels. Receives: Drug: Torsemide |
| Standard Outpatient Management Group | Active comparator | Subjects will be randomized to standard outpatient heart failure management where they will be prescribed a fixed daily dose of a loop diuretic upon discharge from the hospital and have a follow-up appointment within one week of discharge. All medications including loop diuretic type, dose and frequency will be managed at the discretion of the patient's primary care physician or cardiologist. Study subjects will have a final follow-up appointment at the completion of the study to evaluate current symptoms, weight and perform blood work to assess kidney function, electrolytes and brain natriuretic peptide levels. Receives: Other: Standard Outpatient Heart Failure Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day all-cause readmission rate
To gain an unbiased estimate of 30-day all-cause hospital readmission rate with an individualized weight-based torsemide dosing regimen and with standard therapy
Measured: 30 days from enrollment
Secondary outcomes (4)
Effect size of weight based torsemide regimen compared to standard therapy
To obtain a preliminary estimate of the effect size of an individualized weight-based torsemide regimen intervention using contemporaneous controls of standard care for planning a potential, larger future study
Measured: 30 days from enrollment
Feasibility of a weight based torsemide regimen
To assess the feasibility of subjects to follow an individualized weight-based torsemide regimen as assessed by compliance with study medications, adhering to thrice weekly phone encounters and following medication dose modifications based on the study algorithm. Compliance with the study medication and algorithm will be assessed at the final study appointment by comparing the number of remaining torsemide tablets in the subject's pill box which was provided at the beginning of the study with the number of tablets prescribed during the study.
Measured: 30 days from enrollment
Incidence of acute kidney injury (AKI)
To gain an unbiased estimate of AKI incidence, as defined by an increase serum creatinine by ≥0.3 mg/dL from baseline, with an individualized weight-based torsemide dosing regimen and with standard therapy
Measured: 30 days from enrollment
Comparison of baseline changes of brain natriuretic peptide (BNP) levels
To compare changes in BNP(pg/mL) levels from baseline in subjects randomized to a weight-based torsemide regimen and those randomized to standard therapy
Measured: 30 days from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2017
- Study start17 Apr 2018
- Primary completion14 Mar 2022
- Study completion14 Mar 2022
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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York City Health and Hospitals Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Siegel, New York City Health and Hospitals Corporation
- Investigators
- Robert Siegel, MD, Principal investigator, Jacobi Medical Center, Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03187509
- Sponsor's protocol ID
- 2017-7615
- Status last verified
- Mar 2022
- First submitted
- 9 Jun 2017
- Last updated
- 15 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weight-Based Torsemide Dosing vs. Standard Outpatient Management in Subjects With Heart Failure: A Randomized Open-Label Pilot Study
- ClinicalTrials.gov ID
- NCT03187509
- Acronym / sponsor ID
- 2017-7615
- Conditions
- Heart Failure
- Keywords
- Torsemide, loop diuretics, weight-based
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- New York City Health and Hospitals CorporationUniversity, hospital or other
- Study start
- 17 Apr 2018 (actual)
- Primary completion
- 14 Mar 2022 (actual)
- Study completion
- 14 Mar 2022 (actual)
- First posted
- 15 Jun 2017 (actual)
- 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.
This study will be a randomized open-label pilot study. The purpose of the study is to compare standard of care outpatient heart failure management versus a weight based torsemide regimen. Subjects admitted to the hospital for heart failure exacerbation will be randomized upon discharge to either standard of care outpatient heart failure management or a weight based torsemide regimen. Those subjects randomized to standard of care therapy will be prescribed a daily fixed dose of a loop diuretic at hospital discharge and have a follow-up appointment within one week of discharge. All management decisions including loop diuretic type, dose and frequency will be made at the discretion of the subject's personal physician. Those randomized to an individualized weight based torsemide regimen will be prescribed a dose of torsemide upon hospital discharge based on a prespecified algorithm. These subjects will then undergo physician-subject phone encounters three times a week where the subject's torsemide dose will be modified based on the prespecified algorithm which incorporates current symptoms and weight. Primary end-point will be an unbiased estimate of 30-day all cause readmission rates. Secondary end-points include incidence of acute kidney injury, changes in brain natriuretic peptide levels from baseline and a preliminary estimate of the effect size and feasibility of a weight-based torsemide regimen intervention in order to plan a future larger study.
Detailed description
This study will be an open-label parallel randomized pilot study comparing an individualized weight-based torsemide dosing regimen vs. standard outpatient management in patients with a diagnosis of heart failure.The study will include consenting subjects who are admitted to Jacobi Medical Center with heart failure and were treated with loop diuretic therapy during hospitalization. Prior to discharge, these subjects will be randomized to one of two groups, either an individualized weight-based torsemide regimen group vs. a standard heart failure management group.
After randomization, all subjects will undergo an initial assessment prior to discharge. All subjects will be examined, weighed and assigned a composite congestion score (CCS). CCS is a measurement of current fluid status that has been shown to correlate with clinical outcomes in heart failure patients (19). It assesses a patient's signs and symptoms of congestion, including dyspnea, orthopnea, fatigue, jugular venous distention, rales and peripheral edema. Each category is given a score from 0-3, 0=none, 1=mild,2=moderate and 3=severe. Each subject is given a final composite score for their current volume status.
After discharge, those randomized to standard care will receive standard heart failure care as currently provided in our institution. This routinely includes, but is not limited to, an appointment with their primary care physician within one week of discharge, nutrition consultation, and social work evaluation with support services provided as determined by the social worker. At discharge, all heart failure medication changes including diuretic type, dose and frequency, as well as further management decisions, will be left to the discretion of the subject and the subject's doctors. Those who will be randomized to the individualized weight-based torsemide regimen will be given a standup home scale and torsemide 20mg tabs in a bottle with 100 tablets.
An initial torsemide dose will be assigned based on the patient's GFR and CCS at discharge. These subjects will then have a phone encounter with a physician three times a week where subjects will be instructed to modify the torsemide dose based on their current weight. Patients will be instructed to weigh themselves at the same time of the day, postvoid, prior to eating, prior to the medication dose, and while wearing the same clothing for consistency. The scales should stand on a flat, solid surface rather than carpets unless specifically designed for use in that setting. All phone call encounters and loop diuretic changes will be based on the pre-specified algorithm. These subjects will also receive all the same care and support as a standard subject, including the primary care appointment in one week and other support services, except with instructions to the subject and provider to follow the loop diuretic recommendations from this protocol. Subjects who have been instructed to take more than 80 torsemide 20mg tablets will receive a delivery of 100 additional torsemide 20mg tablets.
All subjects in the study will have follow up visit at week 5 from discharge date. Total diuretic use during the study period will be assessed and current symptoms/quality of life will be evaluated using the Kansas City Cardiomyopathy Questionnaire. The patient will receive a physical examination including a final weight and calculation of composite congestion score. Serum B-type natriuretic peptide (BNP) will be obtained as well as a basic metabolic panel and serum magnesium level to assess for electrolyte disturbances and changes in kidney function. Intervention group subjects will have a count of the remaining number of torsemide tablets in the bottle of torsemide given to them at discharge. Compliance with the algorithm will be assessed by comparing the number of remaining tablets with the number of tablets prescribed during the study. Subjects whose follow-up visit occurs over 45 days after the date of hospital discharge for the enrollment hospitalization shall be deemed to be late for follow-up. Acute kidney injury (AKI) will be defined as an increase in serum creatinine concentration of 0.3 at the five-week follow-up visit compared to the final serum creatinine level measured during hospitalization. Adherence will be measured by comparing the number of tablets in the subject's torsemide supply to the number of expected tablets in the torsemide supply. Adherence will be defined as a tablet count consistent with the subject having taken 88% or more of the expected torsemide tablets
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Weight-Based Torsemide Group | Experimental | Drug: TorsemideSubjects will be randomized to complete a weight-based torsemide dosing regimen for their outpatient heart failure management. These subjects will prescribed a specified dose of torsemide on discharge from the hospital and subsequently have a phone encounter with a physician three times a week where their dose of torsemide will be titrated based on an algorithm which factors in current symptoms and weight. Study subjects will have a final follow-up appointment at the completion of the study to evaluate current symptoms, weight and perform blood work to assess kidney function, electrolytes and brain natriuretic peptide levels. |
| Standard Outpatient Management Group | Active comparator | Other: Standard Outpatient Heart Failure ManagementSubjects will be randomized to standard outpatient heart failure management where they will be prescribed a fixed daily dose of a loop diuretic upon discharge from the hospital and have a follow-up appointment within one week of discharge. All medications including loop diuretic type, dose and frequency will be managed at the discretion of the patient's primary care physician or cardiologist. Study subjects will have a final follow-up appointment at the completion of the study to evaluate current symptoms, weight and perform blood work to assess kidney function, electrolytes and brain natriuretic peptide levels. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All subjects with admission diagnosis of heart failure, including heart failure with reduced ejection fraction (HFrEF) or preserved ejection fraction (HFpEF) treated with loop diuretics during hospitalization
- Must be at least 18 years old at time of enrollment
- Must have reliable access to a telephone, and be able to speak and understand English or Spanish over a telephone connection
Key exclusion criteria (9 listed)
- Any subject who is currently pregnant
- Any subject with end-stage renal disease requiring hemodialysis
- Any subject with serum potassium concentration < 3.5 mEq/L at discharge
- Any subject with serum magnesium concentration < 1.4 mg/dL at discharge
- Any subject with a known history of allergic reaction to loop diuretics
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 |
|---|---|---|
| TorsemideAlso: DemadexThese subjects who are randomized to a weight-based torsemide regimen will be instructed via phone encounters three times per week to take an individualized dose of torsemide based on their current weight and symptoms. These subjects will have a follow-up study appointment at week 5 for a final weight and blood work to assess kidney function, electrolytes and brain-natriuretic peptide levels. | Drug | Weight-Based Torsemide Group |
| Standard Outpatient Heart Failure ManagementThose subjects randomized to standard outpatient management group will be prescribed a daily fixed dose of a loop diuretic upon discharge from the hospital. These subjects will have a follow-up appointment within one week of discharge where all medications including loop diuretic type, dose and frequency will be managed at the discretion of the subject's physician. These subjects will also have a follow-up study appointment at week 5 for a final weight and blood work to assess kidney function, electrolytes and brain-natriuretic peptide levels. | Other | Standard Outpatient Management Group |
Primary outcome
30-day all-cause readmission rate
Time frame: 30 days from enrollment
To gain an unbiased estimate of 30-day all-cause hospital readmission rate with an individualized weight-based torsemide dosing regimen and with standard therapy
4 secondary outcomes
Effect size of weight based torsemide regimen compared to standard therapy
Time frame: 30 days from enrollment
Feasibility of a weight based torsemide regimen
Time frame: 30 days from enrollment
Incidence of acute kidney injury (AKI)
Time frame: 30 days from enrollment
Comparison of baseline changes of brain natriuretic peptide (BNP) levels
Time frame: 30 days from enrollment
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 15 Mar 2022.
- 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.
Robert Siegel, MD principal investigator
Jacobi Medical Center, Albert Einstein College of Medicine
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 Torsemide and Standard Outpatient Heart Failure Management in people with Heart Failure, run by New York City Health and Hospitals Corporation 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 9 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 15 Mar 2022. 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?
30-day all-cause readmission rate (time frame: 30 days from enrollment). 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 15 Mar 2022.