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DART-HA Study: HeartLogic Alerts in Heart Failure

This study, called DART-HA, is looking at how well different standard treatments work for people with congestive heart failure (CHF) who have a Boston Scientific device with HeartLogic enabled. HeartLogic is a feature that can detect early signs of worsening heart failure. If your device shows an alert but you don't have new symptoms, you might be offered observation, or treatment with diuretics (like Furosemide, Torsemide, or Bumetanide) or afterload reduction medications (like sacubitril/valsartan or Hydralazine). The study wants to see how many participants' HeartLogic alerts return to normal within 30, 60, or 90 days. You can join if you are 19 or older, have a Boston Scientific device with HeartLogic, and don't have certain medical conditions that would prevent you from taking sacubitril/valsartan. The current status of this study is unclear.

Study design
This is a single-center, open-label study where participants will be randomly assigned to observation or one of two standard treatments. It plans to enroll 80 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed to assess recovery from HeartLogic Alert at 30, 60, and 90 days.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06218199

Diuretics vs. Afterload Reduction for Treatment of HeartLogic Alerts

Recruiting
PHASE4Ages 19+InterventionalTreatment
Heart Center Research, LLC
~80 participants
Updated 2024-01-29 on ClinicalTrials.gov
What's tested:FurosemideTorsemideBumetanidesacubitril/valsartanHydralazineIsosorbide Dinitrate

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with recovery from HeartLogic Alert
Measured over by 30, 60, 90 days

Conditions

Heart Failure, Congestive

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Heart Failure

NCT06218199

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Heart Center Research, LLC

    Huntsville, Alabamastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Jay Dinerman, MD · PRINCIPAL_INVESTIGATOR · Heart Center Research, LLC

Who to contact

COO
[email protected]
256-519-8472
Email the study team

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Eligibility criteria

Inclusion

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
hepatic disease Child-Pugh class C
Pregnancy/Breast-feeding
Lack of standard contraindications to diuretic therapy
Systolic Blood Pressure \> 105

Exclusion

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
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)

What this trial measures

  • Number of participants with recovery from HeartLogic Alertby 30, 60, 90 days

    change in HeartLogic score to ≤ 6