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Recruiting NCT06218199

Diuretics vs. Afterload Reduction for Treatment of HeartLogic Alerts

Phase IV Interventional Heart Failure, Congestive

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Furosemide, Torsemide, Bumetanide, sacubitril/valsartan.
Who it may be relevant to
Registry conditions: Heart Failure, Congestive. Basic parameters: from 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Number of participants with recovery from HeartLogic Alert [Time frame: by 30, 60, 90 days]
Secondary outcome measures (3)
  • Number of participants with development of symptoms of heart failure decompensation [Time frame: 30, 60, 90 days]
  • Number of participants with unintended office visit, emergency department visit, CHF admission [Time frame: 30, 60, 90 days]
  • Number of participants with Heart Failure Events (HFE) [Time frame: 30, 60, 90 days]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Heart Center Research, LLC — Huntsville

Publications

  • 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

Identifiers

NCT: NCT06218199 · Dart-HA

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗