Heart FailurePhase 4NCT03574857
Prospective Comparison of Metolazone Versus Chlorothiazide for Acute Decompensated Heart Failure With Diuretic Resistance
A Phase 4 study testing Metolazone Oral Tablet and Chlorothiazide Injection in people with Heart Failure and Heart Failure With Reduced Ejection Fraction, run by University of Virginia at 1 site in United States.
Trial summary
The primary objective of the study is to compare efficacy of metolazone and chlorothiazide as add-on therapy in patients refractory to loop diuretics with heart failure with a reduced ejection fraction (HFrEF). This will be a single-center randomized pilot study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Heart Failure With Reduced Ejection Fraction, Heart Failure Acute
- What is being tested?
- Metolazone Oral Tablet and Chlorothiazide Injection
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2018to 1 Jan 2021
- 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
- Age > 18 years old
- Admitted for acute decompensated HF with left ventricular ejection fraction (LVEF) <40%
- Refractory fluid overload:
- Unresponsive (<500 mL net negative over previous 24 hours) AND ineffective diuresis (determined by HF team) to moderate intensity push or low intensity continuous infusion loop diuretic (80 mg IV furosemide or equivalent bumetanide dose of 4 mg)
- English or Spanish-speaking subjects
- Willing and able to comply with study procedures
Who cannot join
- Baseline thiazide use prior to admission or prior to study enrollment
- Renal replacement therapies (RRT) or glomerular filtration rate (GFR) <30 mL/min at the time of enrollment
- Pregnant women
- Cognitive impairment
- Prisoners
- Left ventricular assist devices (LVAD) or temporary mechanical circulatory support devices
Show all 12Show fewer
- History of cardiac transplant
- Reported allergy to thiazides
- No enteral access or unable to take medications enterally
- Palliative diuretics
- Systolic blood pressure (SBP) <90 mm Hg prior to randomization
- Patients receiving concomitant lithium therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia Health System
Charlottesville, Virginia, 22908
About this study
The primary objective of the study is to compare efficacy of metolazone and chlorothiazide as add-on therapy in patients refractory to loop diuretics with heart failure with a reduced ejection fraction (HFrEF). This will be a single-center randomized pilot study.
- Conditions
- Heart Failure, Heart Failure With Reduced Ejection Fraction, Heart Failure Acute, Cardiovascular Diseases
- Being tested
- Metolazone Oral Tablet, Chlorothiazide Injection
- Keywords
- Loop diuretics, Heart failure, Diuretic resistance, Thiazide diuretics
- Medical subject headings
- Heart Failure, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metolazone Oral TabletDrug
Also called Zaroxolyn
Day 1: Metolazone 5 mg PO Day 2: Metolazone 5 mg PO
Chlorothiazide InjectionDrug
Also called Diuril
Day 1: Chlorothiazide 500 mg IV Day 2: Chlorothiazide 500 mg IV
| Study group | Role | What they receive |
|---|---|---|
| Metolazone | Active comparator | Metolazone 5 mg by mouth once daily for 2 days Receives: Drug: Metolazone Oral Tablet |
| Chlorothiazide | Active comparator | Chlorothiazide 500 mg IV once daily for 2 days Receives: Drug: Chlorothiazide Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Net urine output at 24 hours
Milliliters of urine output minus the oral plus intravenous intake
Measured: 24 hours
Secondary outcomes (4)
Net urine output at 48 hours
Milliliters of urine output minus the oral plus IV intake
Measured: 48 hours
Net fluid balance over 12 hours
the net fluid balance over 12 and 24 hours prior to the addition of metolazone or chlorothiazide compared to the 12 hours after addition of the study drug
Measured: 24 hours
Net fluid balance over 24 hours
Net fluid balance over 24 hours prior to the addition of metolazone or chlorothiazide compared to the 24 hours after addition of the study drug
Measured: 48 hours
Weight change
Change in documented weight in kg at 48 hours after starting metolazone or chlorothiazide
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2018
- Study start1 Jun 2018
- Primary completion1 Jan 2021
- Study completion1 Jan 2021
Why it stopped: Low enrollment
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 University of VirginiaThe 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
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emily Burns, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03574857
- Sponsor's protocol ID
- 20455
- Status last verified
- Feb 2021
- First submitted
- 16 Apr 2018
- Last updated
- 16 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Comparison of Metolazone Versus Chlorothiazide for Acute Decompensated Heart Failure With Diuretic Resistance
- ClinicalTrials.gov ID
- NCT03574857
- Acronym / sponsor ID
- 20455
- Conditions
- Heart Failure, Heart Failure With Reduced Ejection Fraction, Heart Failure Acute, Cardiovascular Diseases
- Keywords
- Loop diuretics, Heart failure, Diuretic resistance, Thiazide diuretics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 2 Jul 2018 (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.
The primary objective of the study is to compare efficacy of metolazone and chlorothiazide as add-on therapy in patients refractory to loop diuretics with heart failure with a reduced ejection fraction (HFrEF). This will be a single-center randomized pilot study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metolazone | Active comparator | Drug: Metolazone Oral TabletMetolazone 5 mg by mouth once daily for 2 days |
| Chlorothiazide | Active comparator | Drug: Chlorothiazide InjectionChlorothiazide 500 mg IV once daily for 2 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age > 18 years old
- Admitted for acute decompensated HF with left ventricular ejection fraction (LVEF) <40%
- Refractory fluid overload:
- Unresponsive (<500 mL net negative over previous 24 hours) AND ineffective diuresis (determined by HF team) to moderate intensity push or low intensity continuous infusion loop diuretic (80 mg IV furosemide or equivalent bumetanide dose of 4 mg)
- English or Spanish-speaking subjects
Key exclusion criteria (12 listed)
- Baseline thiazide use prior to admission or prior to study enrollment
- Renal replacement therapies (RRT) or glomerular filtration rate (GFR) <30 mL/min at the time of enrollment
- Pregnant women
- Cognitive impairment
- Prisoners
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 |
|---|---|---|
| Metolazone Oral TabletAlso: ZaroxolynDay 1: Metolazone 5 mg PO Day 2: Metolazone 5 mg PO | Drug | Metolazone |
| Chlorothiazide InjectionAlso: DiurilDay 1: Chlorothiazide 500 mg IV Day 2: Chlorothiazide 500 mg IV | Drug | Chlorothiazide |
Primary outcome
Net urine output at 24 hours
Time frame: 24 hours
Milliliters of urine output minus the oral plus intravenous intake
4 secondary outcomes
Net urine output at 48 hours
Time frame: 48 hours
Net fluid balance over 12 hours
Time frame: 24 hours
Net fluid balance over 24 hours
Time frame: 48 hours
Weight change
Time frame: 48 hours
Results and safety
The study was stopped early (reason given: Low enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2021.
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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.
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 Metolazone Oral Tablet and Chlorothiazide Injection in people with Heart Failure and Heart Failure With Reduced Ejection Fraction, run by University of Virginia 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 6 inclusion and 12 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: stopped early, as of the sponsor's last update on 16 Feb 2021. 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 stopped early (reason given: Low enrollment). Results are not available in the source record.
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?
Net urine output at 24 hours (time frame: 24 hours). 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 16 Feb 2021.