Heart Failure, Congestive
Conditions
Brief 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.
Interventions
DRUGFurosemide
oral administration
DRUGTorsemide
oral administration
DRUGBumetanide
oral administration
DRUGsacubitril/valsartan
oral administration
DRUGHydralazine
oral administration
oral administration
Sponsors
Boston Scientific Corporation
Heart Center Research, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
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 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with recovery from HeartLogic Alert | by 30, 60, 90 days | change in HeartLogic score to ≤ 6 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with development of symptoms of heart failure decompensation | 30, 60, 90 days | change from baseline or new development of, dyspnea, orthopnea, paroxysmal nocturnal dyspnea or edema |
| Number of participants with unintended office visit, emergency department visit, CHF admission | 30, 60, 90 days | office visit, emergency department visit and/or CHF admission |
| Number of participants with Heart Failure Events (HFE) | 30, 60, 90 days | 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. |
Countries
United States
Contacts
Primary ContactCOO
Outcome results
None listed