Heart FailurePhase 4OUTLASTNCT04691687
OUTpatient Intravenous LASix Trial in Reducing Hospitalization for Acute Decompensated Heart Failure
A Phase 4 study testing Furosemide and IV Solution in people with Heart Failure, run by New York Presbyterian Brooklyn Methodist Hospital.
Trial summary
Single-center, prospective double-blinded randomized control trial to evaluate the the feasibility, efficacy and safety of outpatient IV diuretic therapy in treatment of heart failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Furosemide and IV Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2012to 22 Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients being admitted with ADHF over 18 years old
- Known history of systolic or diastolic dysfunction of greater than 6 weeks
- NYHA Class II-IV
- Heart failure as defined in [Table 1]. One symptom must be present at time of screening and one sign must be present in the last 12 months
- Elevated pro-BNP >/= 360 pg/ml and not explained by any other etiology
- Willing to consent and comply with scheduled visits and phone calls
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- Table 1. Criteria for Diagnosing Heart Failure
- SYMPTOMS (at least 1 must be present at time of screening):
- Paroxysmal nocturnal dyspnea
- Orthopnea
- Dyspnea on mild or moderate exertion
- SIGNS (at least 1 must be present in the last 12 months)
- Any rales post cough
- Jugular venous pressure >/= 10 cm H20
- Lower extremity edema
- Chest X-Ray (CXR) demonstrating pleural effusion, pulmonary congestion, or cardiomegaly
Who cannot join
- Systolic blood pressure <85 mmHg
- Signs of significant respiratory distress, according to the discretion of the investigator.
- Biventricular Implantable Cardioverter-Defibrillator(ICD) placement within 15 days, cardiogenic shock or volume depletion
- Chronic dialysis
- Acute renal failure defined as creatinine > 2 x baseline
- Severe systemic illness with life expectancy judged less than three years
Show all 17Show fewer
- Chronic pulmonary disease requiring home O2, oral steroid therapy or hospitalization for exacerbation within 12 months, or significant chronic pulmonary disease in the opinion of the investigator
- Primary hemodynamically significant uncorrected valvular heart disease, obstructive, or regurgitant, or any valvular disease expected to lead to surgery during the trial.
- Atrial fibrillation with resting heart rate >90 bpm
- Myocardial infarction in past 90 days
- Percutaneous coronary intervention in past 30 days
- Heart transplant recipient or currently implanted left ventricular assist device
- Stroke in past 90 days
- No acute infection especially requiring IV antibiotics
- Allergy to Lasix
- Known chronic hepatic disease, defined as aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels > 3.0 times the upper limit of normal
- Non-verbal patients, patients who cannot speak or understand English, patients with dementia and psychiatric illness, patients who are blind or deaf and patients who are transferred to different hospital will be excluded.
About this study
Official title: OUTpatient Intravenous LASix Trial in Reducing Hospitalization for ADHF (OUTLAST)
Single-center, prospective double-blinded randomized control trial to evaluate the the feasibility, efficacy and safety of outpatient IV diuretic therapy in treatment of heart failure.
Read the detailed description
Patients were randomized by a clinical pharmacist with the ratio of 1:1:1 into 3 groups: standard of care control arm (Group 1), IV placebo infusion (Group 2), and IV furosemide infusion (Group 3).Patients in Group 2 and 3 received a comprehensive Heart Failure (HF)-care protocol that included bi-weekly clinic visits for dose-adjusted IV-diuretics, medication adjustment and education. Patients, nurses and treating physicians were blinded to the randomization. Patients in Group 1 received standard of care treatment per heart failure guidelines at the discretion of the primary cardiologist involved in the patient's care.8 Patients in Group 2 received IV saline infusion (20-40 ml) concentrated by the pharmacist to minimize fluid intake. Patients in Group 3 received IV furosemide calculated by the pharmacist to be equivalent or higher in dose compared to the patient's home oral dose. The dose assignments were categorized into low dose (20 mg bolus with 20 mg/hour infusion sessions and 2 ml saline), intermediate dose (40 mg bolus with 40 mg/hour infusion sessions and 4 ml saline) and high dose (80 mg bolus with 80 mg/hour infusion sessions). The infusions were continuous over 3 hours, biweekly over a one-month period. Infusions were held at the discretion of the physician utilizing a written protocol (creatinine 25% above baseline, Systolic Blood Pressure(SBP) <80 mmHg or symptoms of presyncope). Patients in both Groups 2 and 3 resumed all of their oral home medications for HF post infusion visits per standard of care.
- Conditions
- Heart Failure
- Being tested
- Furosemide, IV Solution
- Keywords
- heart failure, hospitalization, diuretics, IV diuretics, mortality
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FurosemideDrug
Also called IV Furosemide
IV loop diuretic therapy
IV SolutionDrug
Also called IV Normal Saline 0.9%
IV Placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care (Group 1) | No intervention | Patients in Group 1 received standard of care treatment per heart failure guidelines at the discretion of the primary cardiologist involved in the patient's care. |
| IV Placebo Infusion | Placebo comparator | Patients in Group 2 received IV saline infusion (20-40 ml) concentrated by the pharmacist to minimize fluid intake.The infusions were continuous over 3 hours, biweekly over a one-month period. Receives: Drug: IV Solution |
| IV Furosemide Infusion | Experimental | The dose assignments were categorized into low dose (20 mg bolus with 20 mg/hour infusion sessions and 2 ml saline), intermediate dose (40 mg bolus with 40 mg/hour infusion sessions and 4 ml saline) and high dose (80 mg bolus with 80 mg/hour infusion sessions). The infusions were continuous over 3 hours, biweekly over a one-month period.Infusions were held at the discretion of the physician utilizing a written protocol (creatinine 25% above baseline, SBP <80 mmHg or symptoms of presyncope). Receives: Drug: Furosemide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Re-hospitalization for Heart Failure
30-day rehospitalization for Heart Failure
Measured: 30 days
Secondary outcomes (3)
Kansas City Cardiomyopathy Questionnaire(KCCQ) outcome measures
Change in Quality of life will be quantified using KCCQ questionnaires
Measured: Change from Baseline to 30 days
Death, Myocardial Infarction, Stroke
Occurrence of death, myocardial infarction, or stroke
Measured: 30 days, 180 days
PHQ-2 outcome measures
Change in depressive symptoms will be quantified using PHQ-2 questionnaire
Measured: Change from Baseline to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2020
- Study start1 May 2012
- Primary completion22 Dec 2017
- Study completion22 Dec 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A single center prospective randomized double-blind controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York Presbyterian Brooklyn Methodist Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr John Heitner, New York Presbyterian Brooklyn Methodist Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04691687
- Sponsor's protocol ID
- 307139
- Other IDs
- 307139
- Acronym
- OUTLAST
- Status last verified
- Dec 2020
- First submitted
- 23 Dec 2020
- Last updated
- 31 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- 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 31 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OUTpatient Intravenous LASix Trial in Reducing Hospitalization for ADHF (OUTLAST)
- ClinicalTrials.gov ID
- NCT04691687
- Acronym / sponsor ID
- OUTLAST / 307139
- Conditions
- Heart Failure
- Keywords
- heart failure, hospitalization, diuretics, IV diuretics, mortality
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- New York Presbyterian Brooklyn Methodist HospitalUniversity, hospital or other
- Study start
- 1 May 2012 (actual)
- Primary completion
- 22 Dec 2017 (actual)
- Study completion
- 22 Dec 2017 (actual)
- First posted
- 31 Dec 2020 (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.
Single-center, prospective double-blinded randomized control trial to evaluate the the feasibility, efficacy and safety of outpatient IV diuretic therapy in treatment of heart failure.
Detailed description
Patients were randomized by a clinical pharmacist with the ratio of 1:1:1 into 3 groups: standard of care control arm (Group 1), IV placebo infusion (Group 2), and IV furosemide infusion (Group 3).Patients in Group 2 and 3 received a comprehensive Heart Failure (HF)-care protocol that included bi-weekly clinic visits for dose-adjusted IV-diuretics, medication adjustment and education. Patients, nurses and treating physicians were blinded to the randomization. Patients in Group 1 received standard of care treatment per heart failure guidelines at the discretion of the primary cardiologist involved in the patient's care.8 Patients in Group 2 received IV saline infusion (20-40 ml) concentrated by the pharmacist to minimize fluid intake. Patients in Group 3 received IV furosemide calculated by the pharmacist to be equivalent or higher in dose compared to the patient's home oral dose. The dose assignments were categorized into low dose (20 mg bolus with 20 mg/hour infusion sessions and 2 ml saline), intermediate dose (40 mg bolus with 40 mg/hour infusion sessions and 4 ml saline) and high dose (80 mg bolus with 80 mg/hour infusion sessions). The infusions were continuous over 3 hours, biweekly over a one-month period. Infusions were held at the discretion of the physician utilizing a written protocol (creatinine 25% above baseline, Systolic Blood Pressure(SBP) <80 mmHg or symptoms of presyncope). Patients in both Groups 2 and 3 resumed all of their oral home medications for HF post infusion visits per standard of care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- A single center prospective randomized double-blind controlled trial
| Arm | Type | Receives |
|---|---|---|
| Standard of Care (Group 1) | No intervention | –Patients in Group 1 received standard of care treatment per heart failure guidelines at the discretion of the primary cardiologist involved in the patient's care. |
| IV Placebo Infusion | Placebo comparator | Drug: IV SolutionPatients in Group 2 received IV saline infusion (20-40 ml) concentrated by the pharmacist to minimize fluid intake.The infusions were continuous over 3 hours, biweekly over a one-month period. |
| IV Furosemide Infusion | Experimental | Drug: FurosemideThe dose assignments were categorized into low dose (20 mg bolus with 20 mg/hour infusion sessions and 2 ml saline), intermediate dose (40 mg bolus with 40 mg/hour infusion sessions and 4 ml saline) and high dose (80 mg bolus with 80 mg/hour infusion sessions). The infusions were continuous over 3 hours, biweekly over a one-month period.Infusions were held at the discretion of the physician utilizing a written protocol (creatinine 25% above baseline, SBP <80 mmHg or symptoms of presyncope). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Patients being admitted with ADHF over 18 years old
- Known history of systolic or diastolic dysfunction of greater than 6 weeks
- NYHA Class II-IV
- Heart failure as defined in [Table 1]. One symptom must be present at time of screening and one sign must be present in the last 12 months
- Elevated pro-BNP >/= 360 pg/ml and not explained by any other etiology
Key exclusion criteria (17 listed)
- Systolic blood pressure <85 mmHg
- Signs of significant respiratory distress, according to the discretion of the investigator.
- Biventricular Implantable Cardioverter-Defibrillator(ICD) placement within 15 days, cardiogenic shock or volume depletion
- Chronic dialysis
- Acute renal failure defined as creatinine > 2 x baseline
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 |
|---|---|---|
| FurosemideAlso: IV FurosemideIV loop diuretic therapy | Drug | IV Furosemide Infusion |
| IV SolutionAlso: IV Normal Saline 0.9%IV Placebo comparator | Drug | IV Placebo Infusion |
Primary outcome
Re-hospitalization for Heart Failure
Time frame: 30 days
30-day rehospitalization for Heart Failure
3 secondary outcomes
Kansas City Cardiomyopathy Questionnaire(KCCQ) outcome measures
Time frame: Change from Baseline to 30 days
Death, Myocardial Infarction, Stroke
Time frame: 30 days, 180 days
PHQ-2 outcome measures
Time frame: Change from Baseline to 30 days
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 31 Dec 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Furosemide and IV Solution in people with Heart Failure, run by New York Presbyterian Brooklyn Methodist Hospital.
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 16 inclusion and 17 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 31 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
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 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?
Re-hospitalization for Heart Failure (time frame: 30 days). 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 31 Dec 2020.