Last updated: January 25, 2024
Sponsor: Heart Center Research, LLC
Overall Status: Active - Recruiting
Phase
4
Condition
Congestive Heart Failure
Heart Failure
Hyponatremia
Treatment
sacubitril/valsartan
Isosorbide Dinitrate
Hydralazine
Clinical Study ID
NCT06218199
Dart-HA
Ages > 19 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 IIreceptor 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
Exclusion Criteria:
- Glomerular filtration rate <25 mL/min who are non-responsive to diuretic therapy orare 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) ineffective 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 timeof 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 ventricularassist 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)
Study Design
Total Participants: 80
Treatment Group(s): 6
Primary Treatment: sacubitril/valsartan
Phase: 4
Study Start date:
July 08, 2021
Estimated Completion Date:
December 31, 2026
Study Description
Connect with a study center
Heart Center Research, LLC
Huntsville, Alabama 35801
United StatesActive - Recruiting
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