Heart FailurePhase 4NCT03999216
Comparing Diuretic Strategies in Hospitalized Heart Failure
A Phase 4 study testing Loop Diuretics vs. loop + thiazide diuretics in people with Heart Failure, run by Stanford University at 1 site in United States.
Trial summary
We will conduct a pragmatic randomized trial comparing whether using a combination of two types of diuretics (loop + thiazide) compared with using a single diuretic (loop only) will result in shorter hospital stays for patients hospitalized with 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?
- Loop Diuretics vs. loop + thiazide diuretics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2023to Jun 2024
- 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
- Any adult (age ≥18 years) admitted to the Heart Failure Service at Stanford Health Care with an indication for treatment with a diuretic.
Who cannot join
- admission to the intensive care unit or cardiac care units
- maintenance dialysis on admission
- any mechanical circulatory support on admission
- history of heart transplant
- allergy / intolerance to loop or thiazide diuretics
- admission serum sodium < 125 meq/L (from EPIC)
- admission serum potassium < 3.0 meq/L (from EPIC)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Creating a Platform for Point-of-Care Pragmatic Clinical Trials: Comparing Diuretic Strategies in Heart Failure
We will conduct a pragmatic randomized trial comparing whether using a combination of two types of diuretics (loop + thiazide) compared with using a single diuretic (loop only) will result in shorter hospital stays for patients hospitalized with heart failure.
- Conditions
- Heart Failure
- Being tested
- Loop Diuretics vs. loop + thiazide diuretics
- Keywords
- diuretics
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Loop Diuretics vs. loop + thiazide diureticsDrug
Participants will receive the diuretic type as determined by the randomized group assignment starting within the first 24 hours of hospital admission and continuing for up to 72 hours. All other treatments are left to the discretion of the treatment team, as this is a pragmatic randomized trial.
| Study group | Role | What they receive |
|---|---|---|
| Loop only | Active comparator | Participants will receive a loop diuretic for up to the first 72 hours of hospitalization. The specific drug, dose and route are left to the treating providers. Receives: Drug: Loop Diuretics vs. loop + thiazide diuretics |
| Loop + Thiazide | Active comparator | Participants will receive a loop+thiazide diuretic for up to the first 72 hours of hospitalization. The specific drugs, doses and routes are left to the treating providers. Receives: Drug: Loop Diuretics vs. loop + thiazide diuretics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital length of stay
Measured: During hospitalization up to 90 days
Secondary outcomes (1)
Composite of all-cause rehospitalizations, emergency department visits, or death in the 30 days after hospital discharge.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2019
- Study startJul 2023 (estimated)
- Primary completionJan 2024 (estimated)
- Study completionJun 2024 (estimated)
Why it stopped: Due to administrative and logistical barriers this trial has been withdrawn.
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 Stanford 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Principal investigator, Tara I-Hsin Chang, Stanford University
- Investigators
- Tara Chang, MD, MS, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03999216
- Sponsor's protocol ID
- 51720
- Status last verified
- Apr 2023
- First submitted
- 24 Jun 2019
- Last updated
- 12 Apr 2023
- 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 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creating a Platform for Point-of-Care Pragmatic Clinical Trials: Comparing Diuretic Strategies in Heart Failure
- ClinicalTrials.gov ID
- NCT03999216
- Acronym / sponsor ID
- 51720
- Conditions
- Heart Failure
- Keywords
- diuretics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to administrative and logistical barriers this trial has been withdrawn.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- Jul 2023 (estimated)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 26 Jun 2019 (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.
We will conduct a pragmatic randomized trial comparing whether using a combination of two types of diuretics (loop + thiazide) compared with using a single diuretic (loop only) will result in shorter hospital stays for patients hospitalized with heart failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Loop only | Active comparator | Drug: Loop Diuretics vs. loop + thiazide diureticsParticipants will receive a loop diuretic for up to the first 72 hours of hospitalization. The specific drug, dose and route are left to the treating providers. |
| Loop + Thiazide | Active comparator | Drug: Loop Diuretics vs. loop + thiazide diureticsParticipants will receive a loop+thiazide diuretic for up to the first 72 hours of hospitalization. The specific drugs, doses and routes are left to the treating providers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any adult (age ≥18 years) admitted to the Heart Failure Service at Stanford Health Care with an indication for treatment with a diuretic.
Key exclusion criteria (7 listed)
- admission to the intensive care unit or cardiac care units
- maintenance dialysis on admission
- any mechanical circulatory support on admission
- history of heart transplant
- allergy / intolerance to loop or thiazide 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 |
|---|---|---|
| Loop Diuretics vs. loop + thiazide diureticsParticipants will receive the diuretic type as determined by the randomized group assignment starting within the first 24 hours of hospital admission and continuing for up to 72 hours. All other treatments are left to the discretion of the treatment team, as this is a pragmatic randomized trial. | Drug | Loop + Thiazide, Loop only |
Primary outcome
Hospital length of stay
Time frame: During hospitalization up to 90 days
1 secondary outcome
Composite of all-cause rehospitalizations, emergency department visits, or death in the 30 days after hospital discharge.
Time frame: 30 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 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.
Tara Chang, MD, MS principal investigator
Stanford 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 Loop Diuretics vs. loop + thiazide diuretics in people with Heart Failure, run by Stanford 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 1 inclusion and 7 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: withdrawn, as of the sponsor's last update on 12 Apr 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 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 was withdrawn before enrolling participants, so there are no results.
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?
Hospital length of stay (time frame: During hospitalization up to 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 12 Apr 2023.