Diuretics vs. Afterload Reduction for Treatment of HeartLogic Alerts (DART-HA)
Heart Center Research, LLC
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.
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, inciden…
Eligibility
- Age range
- 19+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 Criteria: * Glomerular filtration rate \<25 mL/min who are non-responsive to…
Interventions
- DrugFurosemide
oral administration
- DrugTorsemide
oral administration
- DrugBumetanide
oral administration
- Drugsacubitril/valsartan
oral administration
- DrugHydralazine
oral administration
- DrugIsosorbide Dinitrate
oral administration
Location
- Heart Center Research, LLCHuntsville, Alabama