Diuretics vs. Afterload Reduction for Treatment of HeartLogic Alerts

NCT ID: NCT06218199

Last Updated: 2024-01-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-08
• Study Completion Date: 2026-12-31

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.

Conditions

Heart Failure, Congestive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Diuretic protocol

If asymptomatic at time of HeartLogic(HL) alert, will add or increase diuretic based on current medications.

If currently taking ≤ 20 mg. furosemide, begin furosemide 40mg orally daily until recovery from alert or re-alert. If currently taking ≥ 40mg furosemide begin torsemide 20 mg orally daily or bumetanide 1 mg orally daily. If patient unable to obtain torsemide or bumetanide double furosemide daily dose (maximum 480mg daily).

If currently taking ≥ 20mg torsemide or ≥ 1mg bumetanide, double daily dose. Recheck HeartLogic index 7 days following initiation of diuretic protocol. If patient recovers from alert consider reducing dose or stopping diuretic. If HeartLogic index is lower but still in alert continue current diuretic dose. If HeartLogic index is the same or higher double diuretic dose and/or add metolazone 2.5mg for 1-2 days.

Group Type: ACTIVE_COMPARATOR

Furosemide

Intervention Type: DRUG

oral administration

Torsemide

Intervention Type: DRUG

oral administration

Bumetanide

Intervention Type: DRUG

oral administration

Afterload reduction protocol

If asymptomatic at time of HL alert, increase afterload reduction drugs based on current medications.

If on Sacubitril/valsartan, double the dose. If on maximum Sacubitril/valsartan, add Hydralazine 10mg and Isordil10 mg both three times a day. If on Angiotensin Receptor Blocker (ARB) at low dose (less than or equal to Valsartan 160mg daily or equivalent) then stop ARB and start sacubitril/valsartan 24-26mg twice a day. If on ARB at high dose (greater than Valsartan 160mg daily or equivalent) then immediately stop ARB and start Sacubitril/valsartan 49-51mg twice a day. If on Angiotensin-converting enzyme (ACE) inhibitor at low dose (less than or equal to 10mg daily or equivalent) then immediately stop ACE inhibitor and start Sacubitril/valsartan 24-26mg twice a day after 48hours. If on ACE inhibitor at high dose (greater than Enalapril 10mg daily or equivalent) stop ACE inhibitor and start Sacubitril/valsartan 49-51mg twice a day after 48hours. Cut diuretic in half for all.

Group Type: ACTIVE_COMPARATOR

sacubitril/valsartan

Intervention Type: DRUG

oral administration

Hydralazine

Intervention Type: DRUG

oral administration

Isosorbide Dinitrate

Intervention Type: DRUG

oral administration

Observation protocol

Standard therapy offered until development of symptoms of heart failure decompensation occurs. Patients will be monitored until out of alert and at 30, 60, and 90 days.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Furosemide

oral administration

Intervention Type: DRUG

Torsemide

oral administration

Intervention Type: DRUG

Bumetanide

oral administration

Intervention Type: DRUG

sacubitril/valsartan

oral administration

Intervention Type: DRUG

Hydralazine

oral administration

Intervention Type: DRUG

Isosorbide Dinitrate

oral administration

Intervention Type: DRUG

Other Intervention Names

Lasix; Demadex; Bumex; Entresto; Apresoline; Dilatrate, Isordil

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)

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: collaborator

Heart Center Research, LLC

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jay Dinerman, MD

Role: PRINCIPAL_INVESTIGATOR

Heart Center Research, LLC

Locations

Heart Center Research, LLC

Huntsville, Alabama, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

COO

Role: CONTACT

leskridge@theheartcenter.md

256-519-8472

Facility Contacts

COO

Role: primary

leskridge@theheartcenter.md

256-519-8472

References

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.

Reference Type: RESULT

PMID: 35460884 (View on PubMed)

Other Identifiers

Dart-HA

Identifier Type: -

Identifier Source: org_study_id