Status:
RECRUITING
Diuretics vs. Afterload Reduction for Treatment of HeartLogic Alerts
Lead Sponsor:
Heart Center Research, LLC
Collaborating Sponsors:
Boston Scientific Corporation
Conditions:
Heart Failure, Congestive
Eligibility:
All Genders
19+ years
Phase:
PHASE4
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 reduct...
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 the...
Eligibility Criteria
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
- 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)
Key Trial Info
Start Date :
July 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06218199
Start Date
July 8 2021
End Date
December 31 2026
Last Update
January 29 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Heart Center Research, LLC
Huntsville, Alabama, United States, 35801