Recruiting

Diuretics vs. Afterload Reduction

Sponsor:

Heart Center Research, LLC

Code:

NCT06218199

Conditions

Heart Failure, Congestive

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Interventions

Furosemide

Torsemide

Bumetanide

sacubitril/valsartan

Hydralazine

Study Details

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 reduction therapy) in patients without new symptoms who have developed abnormalities of the HeartLogic heart failure diagnostic feature.

Conditions

Heart Failure, Congestive

Study ID

NCT06218199

Start date

Jul 8, 2021

Status verified date

Jan, 2024

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

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 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 Criteria:

  • 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)

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Furosemide

oral administration

Torsemide

oral administration

Bumetanide

oral administration

sacubitril/valsartan

oral administration

Hydralazine

oral administration

Isosorbide Dinitrate

oral administration

Primary outcome measure

  • Number of participants with recovery from HeartLogic Alert [ Time Frame: by 30, 60, 90 days ]

Central Contacts and Locations

Central contacts

COO

256-519-8472leskridge@theheartcenter.md

Locations

Heart Center Research, LLC

Recruiting

Huntsville, Alabama, United States, 35801

Contacts

COO

256-519-8472leskridge@theheartcenter.md

Principal Investigator:

Jay Dinerman, MD

More Information

Sponsor

Heart Center Research, LLC

Last update posted

Jan 29, 2024

Last verified

Jan, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Heart Center Research, LLC on 2024-01-29.