Diuretics vs. Afterload Reduction for Treatment of HeartLogic Alerts

Официальное название

Diuretics vs. Afterload Reduction for Treatment of HeartLogic Alerts (DART-HA)

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Furosemide
  oral administration
• Препарат Torsemide
  oral administration
• Препарат Bumetanide
  oral administration
• Препарат sacubitril/valsartan
  oral administration
• Препарат Hydralazine
  oral administration
• Препарат Isosorbide Dinitrate
  oral administration

Первичные конечные точки

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

Вторичные конечные точки (3)

• Number of participants with development of symptoms of heart failure decompensation [Срок оценки: 30, 60, 90 days]
• Number of participants with unintended office visit, emergency department visit, CHF admission [Срок оценки: 30, 60, 90 days]
• Number of participants with Heart Failure Events (HFE) [Срок оценки: 30, 60, 90 days]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Heart Center Research, LLC — Huntsville

Публикации

• 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. PMID 35460884

Идентификаторы

NCT: NCT06218199 · Dart-HA

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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