Compares heart failure medicines for patients with early warning signs on a heart monitor
Compares diuretics and afterload-reducing drugs in heart failure patients without new symptoms.
Plain-language title generated from the registry record
Registry title: Diuretics vs. Afterload Reduction for Treatment of HeartLogic Alerts
Key facts
- Where
- Huntsville, United StatesSee the site
- Phase
- Phase 4
Where in United States
- Heart Center Research, LLCHuntsville, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Heart Center Research, LLC
- Trial code
- NCT06218199
- Record updated
- 29 January 2024
- Original description
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.Read full original descriptionShow less
Diuretics vs. Afterload Reduction for Treatment of HeartLogic Alerts (DART-HA)
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.
Inclusion: 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: Glomerular filtration rate <25 mL/min who are non-responsive to diuretic therapy or are on chronic renal dialysis; subject has received or is scheduled to receive a heart transplant or ventricular assist device within the next 6 months; 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 %); Symptomatic heart failure at rest or New York Heart Association Class IV at the time of enrollment; regularly scheduled IV heart failure therapy (e.g. inotropes or diuretics); the subject is unable to sign or refuses to sign the patient informed consent; the subject is implanted with unipolar right atrial or right ventricular leads; subject is pregnant or planning to become pregnant during the study.