Diuretics vs. Afterload Reduction for Treatment of HeartLogic Alerts

NCT06218199 | Recruiting Phase 4 FDA Drug

• 1 other identifier: Dart-HA
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure, Congestive

Outcome Measures

Primary Outcomes (1)

• Number of participants with recovery from HeartLogic Alert

  change in HeartLogic score to ≤ 6

  by 30, 60, 90 days

Secondary Outcomes (3)

• Number of participants with development of symptoms of heart failure decompensation

  30, 60, 90 days

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

  30, 60, 90 days

• Number of participants with Heart Failure Events (HFE)

  30, 60, 90 days

Study Arms (3)

Diuretic protocol

ACTIVE COMPARATOR

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.

Drug: Furosemide; Drug: Torsemide; Drug: Bumetanide

Afterload reduction protocol

ACTIVE COMPARATOR

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.

Drug: sacubitril/valsartan; Drug: Hydralazine; Drug: Isosorbide Dinitrate

Observation protocol

NO INTERVENTION

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.

Interventions

Furosemide DRUG

oral administration

Also known as: Lasix

Diuretic protocol

Torsemide DRUG

oral administration

Also known as: Demadex

Diuretic protocol

Bumetanide DRUG

oral administration

Also known as: Bumex

Diuretic protocol

sacubitril/valsartan DRUG

oral administration

Also known as: Entresto

Afterload reduction protocol

Hydralazine DRUG

oral administration

Also known as: Apresoline

Afterload reduction protocol

Isosorbide Dinitrate DRUG

oral administration

Also known as: Dilatrate, Isordil

Afterload reduction protocol

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Heart Center Research, LLC: lead
• Boston Scientific Corporation: collaborator

Study Sites (1)

Heart Center Research, LLC

Huntsville, Alabama, 35801, United States

RECRUITING

Related 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 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.

  PMID: 35460884 RESULT

MeSH Terms

Conditions

Heart Failure

Interventions

Furosemide; Torsemide; Bumetanide; sacubitril and valsartan sodium hydrate drug combination; Hydralazine; Isosorbide Dinitrate

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Sulfanilamides; Sulfonamides; Amides; Organic Chemicals; Aniline Compounds; Amines; Sulfones; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; meta-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phthalazines; Pyridazines; Isosorbide; Sorbitol; Sugar Alcohols; Alcohols; Carbohydrates

Study Officials

• Jay Dinerman, MD

  Heart Center Research, LLC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

COO

CONTACT

256-519-8472; leskridge@theheartcenter.md

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2024
• First Posted: January 23, 2024
• Study Start: July 8, 2021
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 29, 2024

Record last verified: 2024-01

Locations

US (1)