Actively Recruiting
Diuretics vs. Afterload Reduction for Treatment of HeartLogic Alerts
Led by Heart Center Research, LLC · Updated on 2024-01-29
80
Participants Needed
1
Research Sites
286 weeks
Total Duration
On this page
Sponsors
H
Heart Center Research, LLC
Lead Sponsor
B
Boston Scientific Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Diuretics vs. Afterload Reduction for Treatment of HeartLogic Alerts
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Boston Scientific device with HeartLogic enabled
- No standard contraindications to sacubitril/valsartan such as history of ACE-inhibitor or ARB induced angioedema, hypotension, hypovolemia, renal artery stenosis, renal failure, hyperkalemia, severe hepatic disease, or pregnancy/breast-feeding
- No standard contraindications to diuretic therapy
- Systolic blood pressure greater than 105 mmHg
You will not qualify if you...
- Glomerular filtration rate below 25 mL/min with non-responsiveness to diuretics or on chronic renal dialysis
- Current symptoms of heart failure worsening such as increased shortness of breath or fatigue
- Recent significant change in arrhythmia burden within 2 weeks
- Recent change in cardiac resynchronization therapy delivery within 60 days
- Unable or unwilling to sign informed consent
- Symptomatic heart failure at rest or New York Heart Association Class IV at enrollment
- Implanted with unipolar right atrial or right ventricular leads
- Received or planned heart transplant or ventricular assist device within 6 months
- Pregnant or planning pregnancy during the study
- Regularly scheduled intravenous heart failure treatments such as inotropes or diuretics
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Heart Center Research, LLC
Huntsville, Alabama, United States, 35801
Actively Recruiting
Research Team
C
COO
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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