Clinical trial NCT06218199: Diuretics vs. Afterload Reduction for Treatment of HeartLogic Alerts
Official title: Diuretics vs. Afterload Reduction for Treatment of HeartLogic Alerts (DART-HA)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Heart Failure, Congestive
Lead sponsor: Heart Center Research, LLC
Sponsor class: NETWORK
Collaborators: name: Boston Scientific Corporation
First posted: 2024-01-23
Enrollment: 80
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 their HeartLogic score which is indicative of worsening heart failure. Subjects whose devices demonstrate HeartLogic score elevations and also do not demonstrate symptoms from heart failure will be randomized to observation or one of two standard treatments for worsening heart failure, afterload reduction or diuretic therapy. Subjects will be followed to assess the change in HeartLogic score, incidence of the the HeartLogic score returning to normal levels, the development of symptoms of heart failure and/or the need for treatment for heart failure.

Eligibility criteria: 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)

Primary outcomes:
measure: Number of participants with recovery from HeartLogic Alert
timeFrame: by 30, 60, 90 days
Secondary outcomes:
measure: Number of participants with development of symptoms of heart failure decompensation
timeFrame: 30, 60, 90 days
measure: Number of participants with unintended office visit, emergency department visit, CHF admission
timeFrame: 30, 60, 90 days
measure: Number of participants with Heart Failure Events (HFE)
timeFrame: 30, 60, 90 days
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Heart Center Research, LLC
state: Alabama
Study officials:
affiliation: Heart Center Research, LLC
name: Jay Dinerman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hernandez AF, Albert NM, Allen LA, Ahmed R, Averina V, Boehmer JP, Cowie MR, Chien CV, Galvao M, Klein L, Kwan B, Lam CSP, Ruble SB, Stolen CM, Stein K; MANAGE-HF Study. Multiple cArdiac seNsors for mAnaGEment of Heart Failure (MANAGE-HF) - Phase I Evaluation of the Integration and Safety of the HeartLogic Multisensor Algorithm in Patients With Heart Failure. J Card Fail. 2022 Aug;28(8):1245-1254. doi: 10.1016/j.cardfail.2022.03.349. Epub 2022 Apr 21.