Congestive Heart FailurePhase 2/3NCT02579057
Sub-Q Versus IV Furosemide in Acute Heart Failure
A Phase 2/3 study testing Furosemide Injection Solution (SCP-101) and Furosemide Injection Solution, USP in people with Congestive Heart Failure, run by Johns Hopkins University at 1 site in United States.
Trial summary
This study evaluates the clinical efficacy of subcutaneously administered Furosemide Injection Solution versus intravenous administration of Furosemide Injection, United States Pharmacopeia (USP) in adult patients presenting to a heart failure clinic with decompensated heart failure. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Congestive Heart Failure
- What is being tested?
- Furosemide Injection Solution (SCP-101) and Furosemide Injection Solution, USP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to Jul 2017
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- An Institutional Review Board (IRB) approved informed consent is signed and dated prior to any study-related activities.
- Male and female subjects > 18 years of age
- History of at least 3 months treated heart failure (NYHA class II/III/IV), or recent hospitalization for heart failure; presenting to Heart Failure Bridge Clinic (HFBC) with decompensated heart failure symptoms including elevated jugular venous pressure, dyspnea and peripheral edema where the decision is made to give IV diuretics
- Able to participate in the study in the opinion of the investigator
- Has the ability to understand the requirements of the study and is willing to comply with all study procedures
Who cannot join
- Presenting with symptoms where it is anticipated that there is a high chance of hospitalization such as ischemia, uncontrolled arrhythmia, infection, hemodynamic instability (elevated or low blood pressure), respiratory compromise, or electrolyte abnormalities (>25% increase in creatinine from baseline, potassium, hyponatremia).
- On experimental medication or currently participating in a cardiovascular research study.
- Presence or need for urinary catheterization, urinary tract abnormality or disorder interfering with urination
- Any surgical or medical condition which in the opinion of the investigator may interfere with participation in the study or which may affect the outcome of the study
- Inability to comply with study requirements
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Hospital Heart Failure Bridge Clinic
Baltimore, Maryland, 21287
About this study
Official title: Prospective, Randomized, Parallel-Group Pilot Study Comparing IV Furosemide to Subcutaneous Furosemide in Acute Decompensated Heart Failure Patients
This study evaluates the clinical efficacy of subcutaneously administered Furosemide Injection Solution versus intravenous administration of Furosemide Injection, United States Pharmacopeia (USP) in adult patients presenting to a heart failure clinic with decompensated heart failure. Half of the patients will receive a subcutaneously administered Furosemide Injection Solution; the other half will receive an intravenous administration of Furosemide Injection.
Read the detailed description
The prevalence of chronic heart failure is increasing, and despite advances in the treatment of chronic heart failure, in-hospital mortality and readmission are high. Heart failure costs the US about 32 billion per year, and a large percentage of the costs are due to hospitalizations. Most clinicians would agree that patients with decompensated heart failure presenting with hypotension, worsening renal function and altered mental status should be hospitalized. However, there is a subset of patients presenting with dyspnea and edema due to volume overload that necessitate rapid symptom improvement but are hemodynamically stable. Oral diuretics would likely be ineffective but hospital admission for IV diuretics seems excessive.
The research hypothesis is that subcutaneously administered furosemide will be an effective alternative to IV furosemide for hemodynamically stable chronic heart failure patients presenting with volume overload in the ambulatory setting. Patients will be randomized to receive Furosemide Injection, USP intravenously or Furosemide Injection Solution (SCP-101) delivered subcutaneously. The IV patients will get the usual care of the heart failure clinic, which includes having an IV placed and delivery of a one-time dose of IV furosemide with the dose determined by the providers (maximum dose 160mg IV). The subcutaneous patients will receive 80mg of Furosemide Injection Solution (SCP-101) administered subcutaneously over 5 hours (30mg in first hour and 12.5mg/hour for 4 hours).
Both groups of patients will be observed for 6 hours to assess diuresis. Patients will be asked to fill out a survey about their symptom improvement (Kansas City Cardiomyopathy questionnaire) and overall satisfaction related to the treatment experience. They will also be monitored for side effects including ototoxicity and discomfort at the access site (burning, itching, and pain). Electrolytes and renal function will be checked once after the patients receive diuretic therapy.
- Conditions
- Congestive Heart Failure
- Being tested
- Furosemide Injection Solution (SCP-101), Furosemide Injection Solution, USP
- Keywords
- Congestive heart failure, Furosemide
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Furosemide Injection Solution (SCP-101)Drug
Also called sc Furosemide
Furosemide Injection Solution, USPDrug
Also called IV furosemide
| Study group | Role | What they receive |
|---|---|---|
| Furosemide Injection Solution, USP | Active comparator | Single dose determined by Investigator (maximum dose 160mg) administered intravenously by IV bolus over approximately 2 minutes (reference treatment) Receives: Drug: Furosemide Injection Solution, USP |
| Furosemide Injection Solution (SCP-101) | Experimental | 80 mg dose administered subcutaneously as 30 mg over the first hour and then as 12.5 mg per hour over the subsequent 4 hours (test treatment) Receives: Drug: Furosemide Injection Solution (SCP-101) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine Output
The volume of urine produced in milliliters over the 6 hours after drug delivery will be measured.
Measured: 6-hour period
Secondary outcomes (3)
Heart Failure Symptom Scoring/Symptom Improvement
Will evaluate if subjective heart failure symptoms improve over the period of diuresis. Measured by Kansas City Cardiomyopathy Questionnaire
Measured: 6-hour period
Number of Participants With Side Effects
Cumulative total of pain, local skin reactions (including hematoma and induration) and electrolyte abnormalities.
Measured: Up to 6 hours
Urine Sodium
Total urinary sodium produced during the 6 hour urine collection
Measured: 6-hour period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2015 (estimated)
- Study startFeb 2016
- Primary completionJun 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- scPharmaceuticals, Inc.
- Responsible party
- Sponsor
- Investigators
- Stuart Russell, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02579057
- Sponsor's protocol ID
- IRB00068019
- Status last verified
- Nov 2017
- First submitted
- 14 Oct 2015
- Last updated
- 18 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Gilotra NA, Princewill O, Marino B, Okwuosa IS, Chasler J, Almansa J, Cummings A, Rhodes P, Chambers J, Cuomo K, Russell SD. Efficacy of Intravenous Furosemide Versus a Novel, pH-Neutral Furosemide Formulation Administered Subcutaneously in Outpatients With Worsening Heart Failure. JACC Heart Fail. 2018 Jan;6(1):65-70. doi: 10.1016/j.jchf.2017.10.001. Epub 2017 Dec 6.
PubMed 29226816
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Parallel-Group Pilot Study Comparing IV Furosemide to Subcutaneous Furosemide in Acute Decompensated Heart Failure Patients
- ClinicalTrials.gov ID
- NCT02579057
- Acronym / sponsor ID
- IRB00068019
- Conditions
- Congestive Heart Failure
- Keywords
- Congestive heart failure, Furosemide
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- scPharmaceuticals, Inc.
- Study start
- Feb 2016 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 19 Oct 2015 (estimated)
- Results
- Posted 17 Nov 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the clinical efficacy of subcutaneously administered Furosemide Injection Solution versus intravenous administration of Furosemide Injection, United States Pharmacopeia (USP) in adult patients presenting to a heart failure clinic with decompensated heart failure. Half of the patients will receive a subcutaneously administered Furosemide Injection Solution; the other half will receive an intravenous administration of Furosemide Injection.
Detailed description
The prevalence of chronic heart failure is increasing, and despite advances in the treatment of chronic heart failure, in-hospital mortality and readmission are high. Heart failure costs the US about 32 billion per year, and a large percentage of the costs are due to hospitalizations. Most clinicians would agree that patients with decompensated heart failure presenting with hypotension, worsening renal function and altered mental status should be hospitalized. However, there is a subset of patients presenting with dyspnea and edema due to volume overload that necessitate rapid symptom improvement but are hemodynamically stable. Oral diuretics would likely be ineffective but hospital admission for IV diuretics seems excessive.
The research hypothesis is that subcutaneously administered furosemide will be an effective alternative to IV furosemide for hemodynamically stable chronic heart failure patients presenting with volume overload in the ambulatory setting. Patients will be randomized to receive Furosemide Injection, USP intravenously or Furosemide Injection Solution (SCP-101) delivered subcutaneously. The IV patients will get the usual care of the heart failure clinic, which includes having an IV placed and delivery of a one-time dose of IV furosemide with the dose determined by the providers (maximum dose 160mg IV). The subcutaneous patients will receive 80mg of Furosemide Injection Solution (SCP-101) administered subcutaneously over 5 hours (30mg in first hour and 12.5mg/hour for 4 hours).
Both groups of patients will be observed for 6 hours to assess diuresis. Patients will be asked to fill out a survey about their symptom improvement (Kansas City Cardiomyopathy questionnaire) and overall satisfaction related to the treatment experience. They will also be monitored for side effects including ototoxicity and discomfort at the access site (burning, itching, and pain). Electrolytes and renal function will be checked once after the patients receive diuretic therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Furosemide Injection Solution, USP | Active comparator | Drug: Furosemide Injection Solution, USPSingle dose determined by Investigator (maximum dose 160mg) administered intravenously by IV bolus over approximately 2 minutes (reference treatment) |
| Furosemide Injection Solution (SCP-101) | Experimental | Drug: Furosemide Injection Solution (SCP-101)80 mg dose administered subcutaneously as 30 mg over the first hour and then as 12.5 mg per hour over the subsequent 4 hours (test treatment) |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- An Institutional Review Board (IRB) approved informed consent is signed and dated prior to any study-related activities.
- Male and female subjects > 18 years of age
- History of at least 3 months treated heart failure (NYHA class II/III/IV), or recent hospitalization for heart failure; presenting to Heart Failure Bridge Clinic (HFBC) with decompensated heart failure symptoms including elevated jugular venous pressure, dyspnea and peripheral edema where the decision is made to give IV diuretics
- Able to participate in the study in the opinion of the investigator
- Has the ability to understand the requirements of the study and is willing to comply with all study procedures
Key exclusion criteria (5 listed)
- Presenting with symptoms where it is anticipated that there is a high chance of hospitalization such as ischemia, uncontrolled arrhythmia, infection, hemodynamic instability (elevated or low blood pressure), respiratory compromise, or electrolyte abnormalities (>25% increase in creatinine from baseline, potassium, hyponatremia).
- On experimental medication or currently participating in a cardiovascular research study.
- Presence or need for urinary catheterization, urinary tract abnormality or disorder interfering with urination
- Any surgical or medical condition which in the opinion of the investigator may interfere with participation in the study or which may affect the outcome of the study
- Inability to comply with study requirements
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 |
|---|---|---|
| Furosemide Injection Solution (SCP-101)Also: sc Furosemide | Drug | Furosemide Injection Solution (SCP-101) |
| Furosemide Injection Solution, USPAlso: IV furosemide | Drug | Furosemide Injection Solution, USP |
Primary outcome
Urine Output
Time frame: 6-hour period
The volume of urine produced in milliliters over the 6 hours after drug delivery will be measured.
3 secondary outcomes
Heart Failure Symptom Scoring/Symptom Improvement
Time frame: 6-hour period
Number of Participants With Side Effects
Time frame: Up to 6 hours
Urine Sodium
Time frame: 6-hour period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29226816Gilotra NA, Princewill O, Marino B, Okwuosa IS, Chasler J, Almansa J, Cummings A, Rhodes P, Chambers J, Cuomo K, Russell SD. Efficacy of Intravenous Furosemide Versus a Novel, pH-Neutral Furosemide Formulation Administered Subcutaneously in Outpatients With Worsening Heart Failure. JACC Heart Fail. 2018 Jan;6(1):65-70. doi: 10.1016/j.jchf.2017.10.001. Epub 2017 Dec 6.
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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.
Stuart Russell, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Furosemide Injection Solution (SCP-101) and Furosemide Injection Solution, USP in people with Congestive Heart Failure, run by Johns Hopkins 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 5 inclusion and 5 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 18 Dec 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Nov 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Urine Output (time frame: 6-hour period). 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 NCT02579057, 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 18 Dec 2017.