Acute Decompensated Heart FailurePhase 2MELT-HFNCT05633758
Metolazone As Early Add On Therapy For Acute Decompensated Heart Failure
A Phase 2 study testing Metolazone in people with Acute Decompensated Heart Failure, run by Scripps Health at 1 site in United States.
Trial summary
The primary objective of the study is to determine efficacy of metolazone as synergistic therapy with Lasix in patients with acute decompensated heart failure. This will be a multicenter double blinded randomized placebo- controlled pilot study of the addition of 5 mg of metolazone per day for 2 days compared to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Decompensated Heart Failure
- What is being tested?
- Metolazone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Mar 2016
- Phase
- Phase 2
- 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
- Subject is 18 years of age at time of enrollment.
- Admitted with acute decompensated heart failure based on history, physical exam, and laboratory parameters, must include both:
- At least 1 symptom of either dyspnea, orthopnea, or edema.
- At least 1 sign of rales on auscultation, peripheral edema, ascites, or pulmonary vascular congestion on chest radiography.
- Be willing to comply with protocol-specified instructions
- Able to understand and grant informed consent.
Who cannot join
- Inability to give informed consent.
- Systolic BP < 90 mmHg
- Creatinine clearance less than 20ml/min or creatinine greater than 2.5mg/dl.
- Serum Sodium less than 128meq/L, potassium levels less than 3.5meq/L
- Known adverse reaction to metolazone
- Inability to take oral medications
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- Severe Aortic Stenosis (AVA < 0.8cm³)
- History of Hypertrophic Obstructive Cardiomyopathy.
- Metastatic Carcinoma
- Severe Chronic Obstructive Pulmonary Disease (COPD), FEV < 1L
- Severe dyspnea requiring prolonged CPAP or intubation
- Moderate/Severe Dementia
Trial locations and contacts
1 site in 1 country.
United States1 site
Scripps Green Torrey Pines
La Jolla, California, 92037
About this study
Official title: Metolazone As Early Add On Therapy For Acute Decompensated Heart Failure (MELT-HF): A Multicenter, Randomized Controlled Trial.
The primary objective of the study is to determine efficacy of metolazone as synergistic therapy with Lasix in patients with acute decompensated heart failure. This will be a multicenter double blinded randomized placebo- controlled pilot study of the addition of 5 mg of metolazone per day for 2 days compared to placebo in patients admitted with acute decompensated heart failure.
Read the detailed description
AS DESCRIBED BY THE PRINCIPAL INVESTIGATOR (DR. HEYWOOD): The primary objective of the study is to determine efficacy of metolazone as synergistic therapy with Lasix in patients with acute decompensated heart failure. This will be a multicenter double blinded randomized placebo- controlled pilot study of the addition of 5 mg of metolazone per day for 2 days compared to placebo in patients admitted with acute decompensated heart failure.
- Conditions
- Acute Decompensated Heart Failure
- Being tested
- Placebo, Metolazone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Also called NA-placebo
All patients will receive standard heart failure therapy, including but not restricted to diuretics, digoxin, angiotensin converting enzyme inhibitors or angiotensin II receptor blockers, beta blockers, aldosterone antagonists, hydralazine, and/or nitrates, at the discretion of the treating physician. After informed consent is obtained, patients will be randomized 1:1 to the treatment arm or placebo arm. The first placebo dose is given within six hours of administration of first dose of intravenous diuretic. The second placebo dose is given at 24-hours after the first dose.
MetolazoneDrug
Also called NA-Metolazone
All patients will receive standard heart failure therapy, including but not restricted to diuretics, digoxin, angiotensin converting enzyme inhibitors or angiotensin II receptor blockers, beta blockers, aldosterone antagonists, hydralazine, and/or nitrates, at the discretion of the treating physician. After informed consent is obtained, patients will be randomized 1:1 to the treatment arm or placebo arm. The first dose of metolazone is given within six hours of administration of first dose of intravenous diuretic The second dose of metolazone is given 24-hours after the first dose.
| Study group | Role | What they receive |
|---|---|---|
| SOC heart failure therapy and placebo pill (Arm A) | Placebo comparator | This group will receive all standard heart failure therapy and placebo pill. Receives: Drug: Placebo |
| SOC heart failure therapy with addition of metolazone (Arm B) | Active comparator | This group will receive all standard heart failure therapy with addition of metolazone. Receives: Drug: Metolazone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total urinary output and negative fluid balance
Total urinary output and negative fluid balance in milliliters (ml) at 48 hours following administration of first dose of intravenous diuretic.
Measured: 48 hours
Secondary outcomes (3)
Change in weight
Change in weight from admission to day 2
Measured: Day 2
Degree of improvement in dyspnea
Dyspnea assessed at 6, 12, 24, 36, and 48 hours with Modified Borg Scale (1-10)
Measured: 6, 12, 24, 36, and 48 hours
All cause mortality
All-cause mortality at 30 days
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 posted1 Dec 2022
- Study startMar 2014
- Primary completionMar 2016
- Study completionMar 2016
Why it stopped: no participants enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Decompensated 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scripps Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James T Heywood, MD, Principal investigator, Scripps Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05633758
- Sponsor's protocol ID
- IRB-14-6311
- Acronym
- MELT-HF
- Status last verified
- Nov 2022
- First submitted
- 21 Nov 2022
- Last updated
- 1 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metolazone As Early Add On Therapy For Acute Decompensated Heart Failure (MELT-HF): A Multicenter, Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT05633758
- Acronym / sponsor ID
- MELT-HF / IRB-14-6311
- Conditions
- Acute Decompensated Heart Failure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Scripps HealthUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 1 Dec 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.
The primary objective of the study is to determine efficacy of metolazone as synergistic therapy with Lasix in patients with acute decompensated heart failure. This will be a multicenter double blinded randomized placebo- controlled pilot study of the addition of 5 mg of metolazone per day for 2 days compared to placebo in patients admitted with acute decompensated heart failure.
Detailed description
AS DESCRIBED BY THE PRINCIPAL INVESTIGATOR (DR. HEYWOOD): The primary objective of the study is to determine efficacy of metolazone as synergistic therapy with Lasix in patients with acute decompensated heart failure. This will be a multicenter double blinded randomized placebo- controlled pilot study of the addition of 5 mg of metolazone per day for 2 days compared to placebo in patients admitted with acute decompensated heart failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SOC heart failure therapy and placebo pill (Arm A) | Placebo comparator | Drug: PlaceboThis group will receive all standard heart failure therapy and placebo pill. |
| SOC heart failure therapy with addition of metolazone (Arm B) | Active comparator | Drug: MetolazoneThis group will receive all standard heart failure therapy with addition of metolazone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject is 18 years of age at time of enrollment.
- Admitted with acute decompensated heart failure based on history, physical exam, and laboratory parameters, must include both:
- Be willing to comply with protocol-specified instructions
- Able to understand and grant informed consent.
Key exclusion criteria (12 listed)
- Inability to give informed consent.
- Systolic BP < 90 mmHg
- Creatinine clearance less than 20ml/min or creatinine greater than 2.5mg/dl.
- Serum Sodium less than 128meq/L, potassium levels less than 3.5meq/L
- Known adverse reaction to metolazone
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 |
|---|---|---|
| PlaceboAlso: NA-placeboAll patients will receive standard heart failure therapy, including but not restricted to diuretics, digoxin, angiotensin converting enzyme inhibitors or angiotensin II receptor blockers, beta blockers, aldosterone antagonists, hydralazine, and/or nitrates, at the discretion of the treating physician. After informed consent is obtained, patients will be randomized 1:1 to the treatment arm or placebo arm. The first placebo dose is given within six hours of administration of first dose of intravenous diuretic. The second placebo dose is given at 24-hours after the first dose. | Drug | SOC heart failure therapy and placebo pill (Arm A) |
| MetolazoneAlso: NA-MetolazoneAll patients will receive standard heart failure therapy, including but not restricted to diuretics, digoxin, angiotensin converting enzyme inhibitors or angiotensin II receptor blockers, beta blockers, aldosterone antagonists, hydralazine, and/or nitrates, at the discretion of the treating physician. After informed consent is obtained, patients will be randomized 1:1 to the treatment arm or placebo arm. The first dose of metolazone is given within six hours of administration of first dose of intravenous diuretic The second dose of metolazone is given 24-hours after the first dose. | Drug | SOC heart failure therapy with addition of metolazone (Arm B) |
Primary outcome
Total urinary output and negative fluid balance
Time frame: 48 hours
Total urinary output and negative fluid balance in milliliters (ml) at 48 hours following administration of first dose of intravenous diuretic.
3 secondary outcomes
Change in weight
Time frame: Day 2
Degree of improvement in dyspnea
Time frame: 6, 12, 24, 36, and 48 hours
All cause mortality
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 1 Dec 2022.
- 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.
James T Heywood, MD principal investigator
Scripps Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Metolazone in people with Acute Decompensated Heart Failure, run by Scripps Health 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: withdrawn, as of the sponsor's last update on 1 Dec 2022. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Total urinary output and negative fluid balance (time frame: 48 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 1 Dec 2022.