Diuretics vs. Afterload Reduction for Treatment of HeartLogic Alerts
Start Date
7/8/2021
Completion Date
12/31/2026
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.
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.
Eligibility Criteria
Age Range: 19 years to No maximum
Interventions
Furosemide
Torsemide
Bumetanide
sacubitril/valsartan
Hydralazine
Isosorbide Dinitrate
Conditions
Locations
Heart Center Research, LLC
Huntsville, Alabama 35801
United States