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| Name | Class |
|---|---|
| Boston Scientific Corporation | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Furosemide | Drug | oral administration |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with recovery from HeartLogic Alert | change in HeartLogic score to ≤ 6 | by 30, 60, 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Number of participants with unintended office visit, emergency department visit, CHF admission |
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Inclusion Criteria:
Boston Scientific device with HeartLogic enabled
Lack of standard contraindications to Sacubitril/valsartan:
Lack of standard contraindications to diuretic therapy
Systolic Blood Pressure > 105
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| COO | Contact | 256-519-8472 | leskridge@theheartcenter.md |
| Name | Affiliation | Role |
|---|---|---|
| Jay Dinerman, MD | Heart Center Research, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heart Center Research, LLC | Recruiting | Huntsville | Alabama | 35801 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35460884 | Result | 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. |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D005665 | Furosemide |
| D000077786 | Torsemide |
| D002034 | Bumetanide |
| C549068 | sacubitril and valsartan sodium hydrate drug combination |
| D006830 | Hydralazine |
| D007548 | Isosorbide Dinitrate |
| ID | Term |
|---|---|
| D013424 | Sulfanilamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| 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. |
| Torsemide | Drug | oral administration |
|
|
| Bumetanide | Drug | oral administration |
|
|
| sacubitril/valsartan | Drug | oral administration |
|
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| Hydralazine | Drug | oral administration |
|
|
| Isosorbide Dinitrate | Drug | oral administration |
|
|
office visit, emergency department visit and/or CHF admission |
| 30, 60, 90 days |
| 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 |
| D000814 |
| Aniline Compounds |
| D000588 | Amines |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D062368 | meta-Aminobenzoates |
| D062365 | Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010793 | Phthalazines |
| D011724 | Pyridazines |
| D007547 | Isosorbide |
| D013012 | Sorbitol |
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D002241 | Carbohydrates |