Health TrialsbyHealthPanel

Diuretics vs. Afterload Reduction for Treatment of HeartLogic Alerts

ConditionHeart Failure, Congestive
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age19+
SponsorHeart Center Research, LLC

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Boston Scientific device with HeartLogic enabled

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

Disqualifiers

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 %)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Furosemide

    Drug

    oral administration

  • Torsemide

    Drug

    oral administration

  • Bumetanide

    Drug

    oral administration

  • sacubitril/valsartan

    Drug

    oral administration

  • Hydralazine

    Drug

    oral administration

  • Isosorbide Dinitrate

    Drug

    oral administration

Treatment groups

80 Participants
are divided into 3 treatment groups
Group A: Diuretic protocolActive comparator 3 interventions
Group B: Afterload reduction protocolActive comparator 3 interventions
Group C: Observation protocolNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Number of participants with recovery from HeartLogic Alert

change in HeartLogic score to ≤ 6

Time frame
by 30, 60, 90 days

Secondary outcomes

1

Number of participants with development of symptoms of heart failure decompensation

change from baseline or new development of, dyspnea, orthopnea, paroxysmal nocturnal dyspnea or edema

Time frame
30, 60, 90 days
2

Number of participants with unintended office visit, emergency department visit, CHF admission

office visit, emergency department visit and/or CHF admission

Time frame
30, 60, 90 days
3

Number of participants with Heart Failure Events (HFE)

1\) the patient was admitted or 2) the patient received 1 or more IV medications (including diuretic agents, inotropes, and vasodilators), or other parenteral therapy.

Time frame
30, 60, 90 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Heart Center Research, LLC

Lead sponsor

Boston Scientific Corporation

Collaborator

Source ClinicalTrials.gov
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