Diuretics vs. Afterload Reduction for Treatment of HeartLogic Alerts (DART-HA)
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:
• 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
Locations
United States
Alabama
Heart Center Research, LLC
RECRUITING
Huntsville
Contact Information
Primary
COO
leskridge@theheartcenter.md
256-519-8472
Time Frame
Start Date:2021-07-08
Estimated Completion Date:2026-12-31
Participants
Target number of participants:80
Treatments
Active_comparator: Diuretic protocol
If asymptomatic at time of HeartLogic(HL) alert, will add or increase diuretic based on current medications.~If currently taking ≤ 20 mg. furosemide, begin furosemide 40mg orally daily until recovery from alert or re-alert. If currently taking ≥ 40mg furosemide begin torsemide 20 mg orally daily or bumetanide 1 mg orally daily. If patient unable to obtain torsemide or bumetanide double furosemide daily dose (maximum 480mg daily).~If currently taking ≥ 20mg torsemide or ≥ 1mg bumetanide, double daily dose. Recheck HeartLogic index 7 days following initiation of diuretic protocol. If patient recovers from alert consider reducing dose or stopping diuretic. If HeartLogic index is lower but still in alert continue current diuretic dose. If HeartLogic index is the same or higher double diuretic dose and/or add metolazone 2.5mg for 1-2 days.
Active_comparator: Afterload reduction protocol
If asymptomatic at time of HL alert, increase afterload reduction drugs based on current medications.~If on Sacubitril/valsartan, double the dose. If on maximum Sacubitril/valsartan, add Hydralazine 10mg and Isordil10 mg both three times a day. If on Angiotensin Receptor Blocker (ARB) at low dose (less than or equal to Valsartan 160mg daily or equivalent) then stop ARB and start sacubitril/valsartan 24-26mg twice a day. If on ARB at high dose (greater than Valsartan 160mg daily or equivalent) then immediately stop ARB and start Sacubitril/valsartan 49-51mg twice a day. If on Angiotensin-converting enzyme (ACE) inhibitor at low dose (less than or equal to 10mg daily or equivalent) then immediately stop ACE inhibitor and start Sacubitril/valsartan 24-26mg twice a day after 48hours. If on ACE inhibitor at high dose (greater than Enalapril 10mg daily or equivalent) stop ACE inhibitor and start Sacubitril/valsartan 49-51mg twice a day after 48hours. Cut diuretic in half for all.
No_intervention: Observation protocol
Standard therapy offered until development of symptoms of heart failure decompensation occurs. Patients will be monitored until out of alert and at 30, 60, and 90 days.