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RecruitingPhase 4NCT06218199

Diuretics vs. Afterload Reduction for Treatment of HeartLogic Alerts

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

Sponsor

Heart Center Research, LLC

Enrollment

80 participants

Start Date

Jul 8, 2021

Study Type

INTERVENTIONAL

Conditions

Heart Failure, Congestive

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 diagnostic feature.

Eligibility

Min Age: 19 Years

Inclusion Criteria10

  • 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 Criteria10

  • 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)

Interventions

DRUGFurosemide

oral administration

DRUGTorsemide

oral administration

DRUGBumetanide

oral administration

DRUGsacubitril/valsartan

oral administration

DRUGHydralazine

oral administration

DRUGIsosorbide Dinitrate

oral administration

Locations(1)

Heart Center Research, LLC

Huntsville, Alabama, United States

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NCT06218199

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