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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Heart Center Research, LLC
Huntsville, Alabama, United States
RECRUITINGNumber of participants with recovery from HeartLogic Alert
change in HeartLogic score to ≤ 6
Time frame: by 30, 60, 90 days
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
Time frame: 30, 60, 90 days
Number of participants with unintended office visit, emergency department visit, CHF admission
office visit, emergency department visit and/or CHF admission
Time frame: 30, 60, 90 days
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.
Time frame: 30, 60, 90 days
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