HF - Heart FailurePhase 4NCT04697485
Polydiuretic Therapy for Heart Failure With Preserved Ejection Fraction and Diabetes Mellitus
A Phase 4 study testing Bumetanide 0.5 mg, dapaglifozin 5 mg, eplerenone 25 mg in people with HF - Heart Failure and Diabetes Mellitus, run by Northwestern University at 1 site in United States.
Trial summary
This is a single-center, non-randomzied pilot study investigating a combination of targeted therapies as possible treatment for heart failure with preserved ejection fraction (HFpEF). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HF - Heart Failure, Diabetes Mellitus
- What is being tested?
- Bumetanide 0.5 mg, dapaglifozin 5 mg, eplerenone 25 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2021to 30 Mar 2022
- 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
- Adults (≥18 years old)
- English speaker
- Established diagnosis of NYHA Class II or III heart failure with preserved ejection fraction, which has been present for at least 2 months
- NB: Patients in which additional pharmacological or device therapy is contemplated, or should be considered, must not be enrolled until therapy has been optimized and is stable for ≥1 month.
- NT-proBNP >600 pg/ml (or if hospitalized for heart failure within the previous 12 months, NT-proBNP ≥400 pg/ml) at enrolment (Visit 1)
- If concomitant atrial fibrillation at Visit 1, NT-proBNP must be ≥900 pg/ml (irrespective of history of heart failure hospitalization)
- Type 2 diabetes mellitus, regardless of background insulin use
Who cannot join
- Known contraindication to bumetanide, eplerenone, or dapagliflozin.
- Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements at visit 1.
- Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment.
- Myocardial infarction, unstable angina, stroke or transient ischemic attack (TIA) within 12 weeks prior to enrollment.
- HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease.
- Type 1 diabetes mellitus
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- Symptomatic bradycardia or second or third-degree heart block without a pacemaker.
- Evidence of secondary cause of hypertension e.g., renal artery stenosis; significant renal impairment (eGFR <50 ml/min/1.73 m2), raised serum potassium (above lab normal limit of 5.5 mEq/L).
- Women who are pregnant, breast feeding or of childbearing potential and are not using and do not plan to continue using medically acceptable form of contraception throughout the study (pharmacological or barrier methods).
- Concomitant illness, physical impairment or mental condition which in the opinion of the study team / primary care physician could interfere with the conduct of the study including outcome assessment.
- Participation in a concurrent interventional medical investigation or pharmacologic clinical trial. Patients in observational, natural history or epidemiological studies not involving an intervention are eligible.
- Participant's responsible primary care or other responsible physician believes it is not appropriate for participant to participate in the study.
- Inability or unwillingness to provide written informed consent.
- Involvement in the planning and/or conduct of the study.
- Receiving current treatment with sulfonylureas.
- Unable to complete study procedures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Polydiuretic Therapy for Heart Failure With Preserved Ejection Fraction and Diabetes Mellitus: A Pilot Trial
This is a single-center, non-randomzied pilot study investigating a combination of targeted therapies as possible treatment for heart failure with preserved ejection fraction (HFpEF).
The study interviention is a Low-Dose, Triple Polydiuretic Therapy (LDTPT, or polydiuretic) including loop diuretic (bumetanide), mineralocorticoid receptor antagonist (eplerenone), and Sodium-glucose co-transporter 2 inhibitors (SGLT2i) therapy (dapaglifozin).
Read the detailed description
Patients with HFpEF and diabetes mellitus will receive polydiuretic therapy consisting of bumetanide 0.5 mg + eplerenone 25 mg + dapaglifozin 5 mg on top of background therapy. These medicines are currently FDA approved and recommended by clinical practice guidelines for the treatment of HFpEF (bumetanide, eplerenone) and diabetes mellitus (dapaglifozin).
This study is designed to evaluate if combination pharmacotherapies with synergistic or additive diuretic properties can improve adherence, treatment efficacy, and effectiveness with fewer side effects
- Conditions
- HF - Heart Failure, Diabetes Mellitus
- Being tested
- Bumetanide 0.5 mg, dapaglifozin 5 mg, eplerenone 25 mg
- Keywords
- HFpEF
- Medical subject headings
- Heart Failure, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bumetanide 0.5 mg, dapaglifozin 5 mg, eplerenone 25 mgDrug
Low-Dose, Triple Polydiuretic Therapy (LDTPT) Treatment consists of:
- Loop diuretic (bumetanide 0.5 mg)
- Mineralocorticoid receptor antagonist (eplerenone 25 mg)
- Sodium-glucose co-transporter 2 inhibitor (SGLT2i): Farxiga® (dapagliflozin) 5 mg
| Study group | Role | What they receive |
|---|---|---|
| Low-Dose, Triple Polydiuretic Therapy (LDTPT) | Experimental | Polydiuretic therapy will consist of bumetanide 0.5 mg + eplerenone 25 mg + dapaglifozin 5 mg once daily for 4 weeks. Receives: Drug: Bumetanide 0.5 mg, dapaglifozin 5 mg, eplerenone 25 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in NT-proBNP
Change in NT-proBNP after 4 weeks of treatment
Measured: 4 weeks
Secondary outcomes (3)
Change in Systolic and Diastolic Blood pressure
Change in blood pressure after 4 weeks of treatment
Measured: 4 weeks
Change in body weight
Change in weight after 4 weeks of treatment
Measured: 4 weeks
Compliance
Overall compliance with polydiuretic as assessed by pill count
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2021
- Study start8 Jan 2021
- Primary completion1 Jan 2022
- Study completion30 Mar 2022 (estimated)
Why it stopped: Enrollment and funding challenges
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HF - Heart FailureStudies of the same condition, open and under way.
- More trials run by Northwestern 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
- Not applicable
- Intervention model
- Single group
- Model description
- This will be a proof-of-concept, non-randomized, pilot study of patients with HFpEF and diabetes mellitus to receiving polydiuretic therapy (bumetanide 0.5 mg + eplerenone 25 mg + dapaglifozin 5 mg) on top of background therapy
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sadiya Khan, Northwestern University
- Investigators
- Sadiya Khan, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04697485
- Sponsor's protocol ID
- STU00213243
- Status last verified
- May 2022
- First submitted
- 7 Dec 2020
- Last updated
- 10 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polydiuretic Therapy for Heart Failure With Preserved Ejection Fraction and Diabetes Mellitus: A Pilot Trial
- ClinicalTrials.gov ID
- NCT04697485
- Acronym / sponsor ID
- STU00213243
- Conditions
- HF - Heart Failure, Diabetes Mellitus
- Keywords
- HFpEF
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Enrollment and funding challenges
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 8 Jan 2021 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 30 Mar 2022 (estimated)
- First posted
- 6 Jan 2021 (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.
This is a single-center, non-randomzied pilot study investigating a combination of targeted therapies as possible treatment for heart failure with preserved ejection fraction (HFpEF).
The study interviention is a Low-Dose, Triple Polydiuretic Therapy (LDTPT, or polydiuretic) including loop diuretic (bumetanide), mineralocorticoid receptor antagonist (eplerenone), and Sodium-glucose co-transporter 2 inhibitors (SGLT2i) therapy (dapaglifozin).
Detailed description
Patients with HFpEF and diabetes mellitus will receive polydiuretic therapy consisting of bumetanide 0.5 mg + eplerenone 25 mg + dapaglifozin 5 mg on top of background therapy. These medicines are currently FDA approved and recommended by clinical practice guidelines for the treatment of HFpEF (bumetanide, eplerenone) and diabetes mellitus (dapaglifozin).
This study is designed to evaluate if combination pharmacotherapies with synergistic or additive diuretic properties can improve adherence, treatment efficacy, and effectiveness with fewer side effects
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This will be a proof-of-concept, non-randomized, pilot study of patients with HFpEF and diabetes mellitus to receiving polydiuretic therapy (bumetanide 0.5 mg + eplerenone 25 mg + dapaglifozin 5 mg) on top of background therapy
| Arm | Type | Receives |
|---|---|---|
| Low-Dose, Triple Polydiuretic Therapy (LDTPT) | Experimental | Drug: Bumetanide 0.5 mg, dapaglifozin 5 mg, eplerenone 25 mgPolydiuretic therapy will consist of bumetanide 0.5 mg + eplerenone 25 mg + dapaglifozin 5 mg once daily for 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults (≥18 years old)
- English speaker
- Established diagnosis of NYHA Class II or III heart failure with preserved ejection fraction, which has been present for at least 2 months
- NT-proBNP >600 pg/ml (or if hospitalized for heart failure within the previous 12 months, NT-proBNP ≥400 pg/ml) at enrolment (Visit 1)
- Type 2 diabetes mellitus, regardless of background insulin use
Key exclusion criteria (16 listed)
- Known contraindication to bumetanide, eplerenone, or dapagliflozin.
- Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements at visit 1.
- Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment.
- Myocardial infarction, unstable angina, stroke or transient ischemic attack (TIA) within 12 weeks prior to enrollment.
- HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease.
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 |
|---|---|---|
| Bumetanide 0.5 mg, dapaglifozin 5 mg, eplerenone 25 mgLow-Dose, Triple Polydiuretic Therapy (LDTPT) Treatment consists of: * Loop diuretic (bumetanide 0.5 mg) * Mineralocorticoid receptor antagonist (eplerenone 25 mg) * Sodium-glucose co-transporter 2 inhibitor (SGLT2i): Farxiga® (dapagliflozin) 5 mg | Drug | Low-Dose, Triple Polydiuretic Therapy (LDTPT) |
Primary outcome
Change in NT-proBNP
Time frame: 4 weeks
Change in NT-proBNP after 4 weeks of treatment
3 secondary outcomes
Change in Systolic and Diastolic Blood pressure
Time frame: 4 weeks
Change in body weight
Time frame: 4 weeks
Compliance
Time frame: 4 weeks
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 10 May 2022.
- Individual participant dataSharing planned: Undecided
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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.
Sadiya Khan, MD principal investigator
Northwestern 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 Bumetanide 0.5 mg, dapaglifozin 5 mg, eplerenone 25 mg in people with HF - Heart Failure and Diabetes Mellitus, run by Northwestern 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 7 inclusion and 16 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 10 May 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. 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?
Change in NT-proBNP (time frame: 4 weeks). 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 10 May 2022; AzTrials last refreshed its copy on 31 Oct 2026.