Heart FailurePhase 4NCT05594823
Flexible vs. Fixed Diuretic Regimen in the Management of Chronic Heart Failure: A Pilot Study
A Phase 4 study testing Ambulatory heart failure management with Flexible Diuretic Regimen with furosemide and Ambulatory heart failure management with fixed dose furosemide in people with Heart Failure and Heart Diseases, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
Heart failure is a major cause of death and hospitalization in Canada. Many of the symptoms experienced by patients with heart failure relate to having fluid accumulate in the lungs causing difficulty breathing, swelling in the legs, and an increase in weight. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Heart Diseases
- What is being tested?
- Ambulatory heart failure management with Flexible Diuretic Regimen with furosemide and Ambulatory heart failure management with fixed dose furosemide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 3 Jan 2023to Jul 2023
- 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
- Diagnosis of heart failure, either reduced (Left ventricular ejection fraction [LVEF] ≤ 40%) or preserved (LVEF > 40%) ejection fraction as measured by echocardiography performed within the last 2 months
- Prescribed and tolerating furosemide with a minimum daily dose of 40mg oral daily
- New York Heart Association (NYHA) Class II or higher symptoms
- NT-proBNP cutoff of ≥ 1000 pg/mL performed within 30 days prior to randomization
- Age > 18 years
- English speaking
- Access to a scale and ability to weigh themselves daily and reliable telephone access
Who cannot join
- Myocardial infarction, coronary artery bypass graft surgery, stent insertion and/or angioplasty within 14 days
- Pregnancy
- Inability to follow directions and self-monitor as part of a flexible diuretic regimen as discerned by the clinician
- Allergic reaction to loop diuretics
- Unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
Andy Jiang, MD contact
Canada1 site, 1 recruiting
- Recruiting
St. Joseph's Health Care
London, Ontario, N6A 4V2
Stuart Smith, MD, (519) 663-3428
About this study
Heart failure is a major cause of death and hospitalization in Canada. Many of the symptoms experienced by patients with heart failure relate to having fluid accumulate in the lungs causing difficulty breathing, swelling in the legs, and an increase in weight. Thus, one of the cornerstones of managing heart failure includes the use of medications known as diuretics that target the kidneys to reduce fluid accumulation via urination. Deciding on the correct dose of this medication can be quite nuanced as under-dosing can lead to accumulation of fluid, and over-dosing can dehydrate patients and potentially result in lightheadedness/fainting and damage to the kidneys. Currently, options for prescribing diuretics for heart failure include 1) giving patients a regular, fixed dose or 2) having patients monitor their daily weight as a surrogate of their fluid status and then take a dose of diuretic based on a pre-prepared scale. The rationale behind the flexible weight-based diuretic scale is that it can potentially detect early fluid accumulation and thus possibly prevent hospitalization or ED visits, and it also avoids over-dosing and potentially dehydrating patients. Currently, it is not clear whether the flexible diuretic regimen is better than the fixed-dose regimen in preventing ED visits, hospitalizations, kidney damage, or death and as such, this pilot study will directly compare the two commonly used regimens in the management of chronic heart failure patients.
- Conditions
- Heart Failure, Heart Diseases
- Being tested
- Ambulatory heart failure management with Flexible Diuretic Regimen with furosemide, Ambulatory heart failure management with fixed dose furosemide
- Keywords
- diuretic, furosemide, flexible diuretic regimen, weight-based
- Medical subject headings
- Heart Failure, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ambulatory heart failure management with Flexible Diuretic Regimen with furosemideOther
Subjects will be given a regimen that determines a variable daily dose of diuretic (furosemide) based on daily self-measured weights as part of the standard of care ambulatory management of chronic heart failure. Follow-up will occur at 90 days with routine bloodwork to monitor renal function.
Ambulatory heart failure management with fixed dose furosemideOther
Subjects will be prescribed a fixed daily dose of diuretic (furosemide) as part of the standard of care ambulatory management of chronic heart failure. Follow-up will occur at 90 days with routine bloodwork to monitor renal function.
| Study group | Role | What they receive |
|---|---|---|
| Fixed - dose diuretic | Active comparator | Pre-determined, fixed daily dose of diuretic (furosemide) Receives: Other: Ambulatory heart failure management with fixed dose furosemide |
| Flexible diuretic regimen | Experimental | Variable daily dose of diuretic (furosemide) determined based on a pre-specified weight-based scale. Receives: Other: Ambulatory heart failure management with Flexible Diuretic Regimen with furosemide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality and morbidity composite outcome
Time to first event of a composite outcome including: ambulatory heart failure visit (clinic or emergency department) requiring intravenous diuretic, an increase in oral diuretic dose greater than or equal to 2.5 times their baseline dose prescribed at time of randomization, or the addition of metolazone; hospitalization for heart failure and/or acute kidney injury defined as a serum creatinine > 1.5 times from baseline at time of randomization; and all-cause death up to 90 days post-randomization
Measured: 90 days
Secondary outcomes (3)
Incidence of acute kidney injury
Rate of acute kidney injury defined as a serum creatinine increase of >1.5 times from baseline at 90 days from randomization
Measured: 90 days
Heart Failure Hospitalizations
Total number of hospitalizations due to heart failure (first and recurrent) during the 90 days post-randomization
Measured: 90 days
All-cause Hospitalizations
Total number of hospitalizations for any cause during the 90 days post-randomization
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2022
- Study start3 Jan 2023
- Primary completionJul 2023 (estimated)
- Study completionJul 2023 (estimated)
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.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stuart Smith, MD, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Stuart Smith, MD, Principal investigator, Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05594823
- Sponsor's protocol ID
- REDA ID: 12724
- Status last verified
- Mar 2023
- First submitted
- 21 Oct 2022
- Last updated
- 13 Mar 2023
- 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 13 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flexible vs. Fixed Diuretic Regimen in the Management of Chronic Heart Failure: A Pilot Study
- ClinicalTrials.gov ID
- NCT05594823
- Acronym / sponsor ID
- REDA ID: 12724
- Conditions
- Heart Failure, Heart Diseases
- Keywords
- diuretic, furosemide, flexible diuretic regimen, weight-based
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 3 Jan 2023 (actual)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 26 Oct 2022 (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.
Heart failure is a major cause of death and hospitalization in Canada. Many of the symptoms experienced by patients with heart failure relate to having fluid accumulate in the lungs causing difficulty breathing, swelling in the legs, and an increase in weight. Thus, one of the cornerstones of managing heart failure includes the use of medications known as diuretics that target the kidneys to reduce fluid accumulation via urination. Deciding on the correct dose of this medication can be quite nuanced as under-dosing can lead to accumulation of fluid, and over-dosing can dehydrate patients and potentially result in lightheadedness/fainting and damage to the kidneys. Currently, options for prescribing diuretics for heart failure include 1) giving patients a regular, fixed dose or 2) having patients monitor their daily weight as a surrogate of their fluid status and then take a dose of diuretic based on a pre-prepared scale. The rationale behind the flexible weight-based diuretic scale is that it can potentially detect early fluid accumulation and thus possibly prevent hospitalization or ED visits, and it also avoids over-dosing and potentially dehydrating patients. Currently, it is not clear whether the flexible diuretic regimen is better than the fixed-dose regimen in preventing ED visits, hospitalizations, kidney damage, or death and as such, this pilot study will directly compare the two commonly used regimens in the management of chronic heart failure patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fixed - dose diuretic | Active comparator | Other: Ambulatory heart failure management with fixed dose furosemidePre-determined, fixed daily dose of diuretic (furosemide) |
| Flexible diuretic regimen | Experimental | Other: Ambulatory heart failure management with Flexible Diuretic Regimen with furosemideVariable daily dose of diuretic (furosemide) determined based on a pre-specified weight-based scale. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of heart failure, either reduced (Left ventricular ejection fraction [LVEF] ≤ 40%) or preserved (LVEF > 40%) ejection fraction as measured by echocardiography performed within the last 2 months
- Prescribed and tolerating furosemide with a minimum daily dose of 40mg oral daily
- New York Heart Association (NYHA) Class II or higher symptoms
- NT-proBNP cutoff of ≥ 1000 pg/mL performed within 30 days prior to randomization
- Age > 18 years
Key exclusion criteria (5 listed)
- Myocardial infarction, coronary artery bypass graft surgery, stent insertion and/or angioplasty within 14 days
- Pregnancy
- Inability to follow directions and self-monitor as part of a flexible diuretic regimen as discerned by the clinician
- Allergic reaction to loop diuretics
- Unable to provide informed consent
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 |
|---|---|---|
| Ambulatory heart failure management with Flexible Diuretic Regimen with furosemideSubjects will be given a regimen that determines a variable daily dose of diuretic (furosemide) based on daily self-measured weights as part of the standard of care ambulatory management of chronic heart failure. Follow-up will occur at 90 days with routine bloodwork to monitor renal function. | Other | Flexible diuretic regimen |
| Ambulatory heart failure management with fixed dose furosemideSubjects will be prescribed a fixed daily dose of diuretic (furosemide) as part of the standard of care ambulatory management of chronic heart failure. Follow-up will occur at 90 days with routine bloodwork to monitor renal function. | Other | Fixed - dose diuretic |
Primary outcome
Mortality and morbidity composite outcome
Time frame: 90 days
Time to first event of a composite outcome including: ambulatory heart failure visit (clinic or emergency department) requiring intravenous diuretic, an increase in oral diuretic dose greater than or equal to 2.5 times their baseline dose prescribed at time of randomization, or the addition of metolazone; hospitalization for heart failure and/or acute kidney injury defined as a serum creatinine > 1.5 times from baseline at time of randomization; and all-cause death up to 90 days post-randomization
3 secondary outcomes
Incidence of acute kidney injury
Time frame: 90 days
Heart Failure Hospitalizations
Time frame: 90 days
All-cause Hospitalizations
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2023.
- 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.
Andy Jiang, MD contact
Stuart Smith, MD principal investigator
Western University
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 Ambulatory heart failure management with Flexible Diuretic Regimen with furosemide and Ambulatory heart failure management with fixed dose furosemide in people with Heart Failure and Heart Diseases, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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 7 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: status not confirmed, as of the sponsor's last update on 13 Mar 2023. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stuart Smith, MD ((519) 663-3428, stuart.smith@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality and morbidity composite outcome (time frame: 90 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 13 Mar 2023.