Diuretics vs. Afterload Reduction for Treatment of HeartLogic Alerts

Heart Failure, Congestive Clinical Trial

— DART-HA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06218199
• Other study ID #: Dart-HA
• Status: Recruiting
• Phase: Phase 4
• Start date: July 8, 2021
• Est. completion date: December 31, 2026

Study information

• Verified date: January 2024
• Source: Heart Center Research, LLC
• Contact: COO
• Phone: 256-519-8472
• Email: leskridge[@]theheartcenter.md
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Congestive

Intervention

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

Locations

Country	Name	City	State
United States	Heart Center Research, LLC	Huntsville	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
Heart Center Research, LLC	Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 Evalua — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with recovery from HeartLogic Alert	change in HeartLogic score to = 6	by 30, 60, 90 days
Secondary	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	30, 60, 90 days
Secondary	Number of participants with unintended office visit, emergency department visit, CHF admission	office visit, emergency department visit and/or CHF admission	30, 60, 90 days
Secondary	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.	30, 60, 90 days