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Heart Failure, CongestivePhase 4DART-HANCT06218199

Diuretics vs. Afterload Reduction for Treatment of HeartLogic Alerts

A Phase 4 study testing Furosemide, Torsemide and Bumetanide in people with Heart Failure, Congestive, run by Heart Center Research, LLC at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The DART-HA study is a single-center, open label, trial intended to evaluate the clinical efficacy of standard treatment options for congestive heart failure (observation, diuretic or afterload reduction therapy) in patients without new symptoms who have developed abnormalities of the HeartLogic heart failure… Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Heart Failure, Congestive
What is being tested?
Furosemide, Torsemide and Bumetanide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteUnited States
Study dates
8 Jul 2021to 31 Dec 2026
Phase
Phase 4
Are there results?
Not yet: the study is under way

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 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Boston Scientific device with HeartLogic enabled
  • Lack of standard contraindications to Sacubitril/valsartan:
  • history of ACE-inhibitor induced angioedema and in those with angiotensin II receptor blocker (ARB) therapy induced angioedema.
  • hypotension, hypovolemia
  • renal artery stenosis, renal failure
  • hyperkalemia
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  • hepatic disease Child-Pugh class C
  • Pregnancy/Breast-feeding
  • Lack of standard contraindications to diuretic therapy
  • Systolic Blood Pressure > 105

Who cannot join

  • Glomerular filtration rate <25 mL/min who are non-responsive to diuretic therapy or are on chronic renal dialysis
  • ongoing symptoms of heart failure decompensation (increased dyspnea and/or fatigue, for purposes of this study increased weight is not considered, see question 2 KCCQ).
  • recent significant change in arrhythmia burden (within the past 2 weeks)
  • in cardiac resynchronization therapy (CRT) patients, recent change (60 days) in effective delivery of CRT (eg. decreased biventricular paving %)
  • the subject is unable to sign or refuses to sign the patient informed consent
  • Symptomatic heart failure at rest or New York Heart Association Class IV at the time of enrollment
Show all 10Show fewer
  • the subject is implanted with unipolar right atrial or right ventricular leads
  • subject has received or is scheduled to receive a heart transplant or ventricular assist device within the next 6 months
  • subject is pregnant or planning to become pregnant during the study
  • regularly scheduled IV heart failure therapy (e.g. inotropes or diuretics)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

COO contact

256-519-8472

leskridge@theheartcenter.md

United States1 site, 1 recruiting

  • Heart Center Research, LLC

    Huntsville, Alabama, 35801

    COO, 256-519-8472, leskridge@theheartcenter.md

    Jay Dinerman, MD

    Recruiting

Other trials in United States

About this study

Official title: Diuretics vs. Afterload Reduction for Treatment of HeartLogic Alerts (DART-HA)

The DART-HA study is a single-center, open label, trial intended to evaluate the clinical efficacy of standard treatment options for congestive heart failure (observation, diuretic or afterload reduction therapy) in patients without new symptoms who have developed abnormalities of the HeartLogic heart failure diagnostic feature.

Read the detailed description

Subjects with congestive heart failure (CHF) who have undergone implantation of a Boston Scientific pacemaker/defibrillator with a HeartLogic sensor will be remotely monitored for for elevation of their HeartLogic score which is indicative of worsening heart failure. Subjects whose devices demonstrate HeartLogic score elevations and also do not demonstrate symptoms from heart failure will be randomized to observation or one of two standard treatments for worsening heart failure, afterload reduction or diuretic therapy. Subjects will be followed to assess the change in HeartLogic score, incidence of the the HeartLogic score returning to normal levels, the development of symptoms of heart failure and/or the need for treatment for heart failure.

Being tested
Furosemide, Torsemide, Bumetanide, sacubitril/valsartan, Hydralazine
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FurosemideDrug

    Also called Lasix

    oral administration

  • TorsemideDrug

    Also called Demadex

    oral administration

  • BumetanideDrug

    Also called Bumex

    oral administration

  • sacubitril/valsartanDrug

    Also called Entresto

    oral administration

  • HydralazineDrug

    Also called Apresoline

    oral administration

  • Isosorbide DinitrateDrug

    Also called Dilatrate, Isordil

    oral administration

Study groups in NCT06218199
Study groupRoleWhat they receive
Diuretic protocolActive comparatorIf asymptomatic at time of HeartLogic(HL) alert, will add or increase diuretic based on current medications. If currently taking ≤ 20 mg. furosemide, begin furosemide 40mg orally daily until recovery from alert or re-alert. If currently taking ≥ 40mg furosemide begin torsemide 20 mg orally daily or bumetanide 1 mg orally daily. If patient unable to obtain torsemide or bumetanide double furosemide daily dose (maximum 480mg daily). If currently taking ≥ 20mg torsemide or ≥ 1mg bumetanide, double daily dose. Recheck HeartLogic index 7 days following initiation of diuretic protocol. If patient recovers from alert consider reducing dose or stopping diuretic. If HeartLogic index is lower but still in alert continue current diuretic dose. If HeartLogic index is the same or higher double diuretic dose and/or add metolazone 2.5mg for 1-2 days.
Receives: Drug: Furosemide; Drug: Torsemide; Drug: Bumetanide
Afterload reduction protocolActive comparatorIf asymptomatic at time of HL alert, increase afterload reduction drugs based on current medications. If on Sacubitril/valsartan, double the dose. If on maximum Sacubitril/valsartan, add Hydralazine 10mg and Isordil10 mg both three times a day. If on Angiotensin Receptor Blocker (ARB) at low dose (less than or equal to Valsartan 160mg daily or equivalent) then stop ARB and start sacubitril/valsartan 24-26mg twice a day. If on ARB at high dose (greater than Valsartan 160mg daily or equivalent) then immediately stop ARB and start Sacubitril/valsartan 49-51mg twice a day. If on Angiotensin-converting enzyme (ACE) inhibitor at low dose (less than or equal to 10mg daily or equivalent) then immediately stop ACE inhibitor and start Sacubitril/valsartan 24-26mg twice a day after 48hours. If on ACE inhibitor at high dose (greater than Enalapril 10mg daily or equivalent) stop ACE inhibitor and start Sacubitril/valsartan 49-51mg twice a day after 48hours. Cut diuretic in half for all.
Receives: Drug: sacubitril/valsartan; Drug: Hydralazine; Drug: Isosorbide Dinitrate
Observation protocolNo interventionStandard therapy offered until development of symptoms of heart failure decompensation occurs. Patients will be monitored until out of alert and at 30, 60, and 90 days.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with recovery from HeartLogic Alert

    change in HeartLogic score to ≤ 6

    Measured: by 30, 60, 90 days

Secondary outcomes (3)

  1. Number of participants with development of symptoms of heart failure decompensation

    change from baseline or new development of, dyspnea, orthopnea, paroxysmal nocturnal dyspnea or edema

    Measured: 30, 60, 90 days

  2. Number of participants with unintended office visit, emergency department visit, CHF admission

    office visit, emergency department visit and/or CHF admission

    Measured: 30, 60, 90 days

  3. Number of participants with Heart Failure Events (HFE)

    1. the patient was admitted or 2) the patient received 1 or more IV medications (including diuretic agents, inotropes, and vasodilators), or other parenteral therapy.

    Measured: 30, 60, 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2024
  2. Study start8 Jul 2021
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

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
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06218199
Sponsor's protocol ID
Dart-HA
Acronym
DART-HA
Status last verified
Jan 2024
First submitted
11 Jan 2024
Last updated
29 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Hernandez AF, Albert NM, Allen LA, Ahmed R, Averina V, Boehmer JP, Cowie MR, Chien CV, Galvao M, Klein L, Kwan B, Lam CSP, Ruble SB, Stolen CM, Stein K; MANAGE-HF Study. Multiple cArdiac seNsors for mAnaGEment of Heart Failure (MANAGE-HF) - Phase I Evaluation of the Integration and Safety of the HeartLogic Multisensor Algorithm in Patients With Heart Failure. J Card Fail. 2022 Aug;28(8):1245-1254. doi: 10.1016/j.cardfail.2022.03.349. Epub 2022 Apr 21.

    PubMed 35460884

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Furosemide, Torsemide and Bumetanide in people with Heart Failure, Congestive, run by Heart Center Research, LLC 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 10 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 29 Jan 2024. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact COO (256-519-8472, leskridge@theheartcenter.md), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with recovery from HeartLogic Alert (time frame: by 30, 60, 90 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06218199, which also lists 1 linked publication.

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 29 Jan 2024.

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