Comparing Diuretic and Afterload Reduction Treatments for HeartLogic Alerts in Heart Failure Patients
A Phase 4 Study Monitoring Boston Scientific Device Users
Led by Heart Center Research, LLC · Updated on 2024-01-29
80
Participants Needed
1
Research Sites
52 weeks
Total Duration
AI-Summary
What this Trial Is About
This research focuses on patients with congestive heart failure CHF who have a Boston Scientific pacemaker or defibrillator equipped with a HeartLogic sensor. The study aims to evaluate standard treatments for CHF when patients show elevated HeartLogic scores but have no new symptoms. It compares outcomes of observation, diuretic therapy, and afterload reduction therapy to understand the best approach for managing these alerts.
Participants with elevated HeartLogic scores without symptoms will be randomly assigned to one of three groups observation only, a diuretic protocol, or an afterload reduction protocol. The diuretic protocol involves adjusting doses of medications like furosemide, torsemide, or bumetanide, with careful monitoring and dose adjustments over time. The afterload reduction protocol involves increasing or adjusting medications such as sacubitrilvalsartan, hydralazine, and isosorbide dinitrate. Treatment continues until symptoms develop or the HeartLogic alert resolves.
During the study, participants will be monitored regularly to track changes in their HeartLogic scores, symptom development, and any heart failure events. Follow-up includes checks at 30, 60, and 90 days after a HeartLogic alert. Researchers will assess how many participants recover from HeartLogic alerts, develop symptoms, or require emergency or hospital visits related to heart failure. The total participation duration and ongoing monitoring aim to capture treatment effects and patient outcomes accurately.
CONDITIONS
Brief Title
Diuretics vs. Afterload Reduction for Treatment of HeartLogic Alerts
Research Team
C
COO
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This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
Factors
Diuretics
Afterload reduction
Usual GDMT
What it is
A randomized arm using loop diuretic therapy in response to a HeartLogic alert
A randomized arm applying afterload‑reducing medications (eg sacubitril/valsartan or vasodilators) when HeartLogic alerts occur
Usual guideline‑directed medical therapy including renin‑angiotensin system inhibition, beta blockers, MRAs and SGLT2 inhibitors in heart failure
Role in trial
Investigational treatment arm responding to HeartLogic alert
Active comparator arm focused on afterload‑reduction in response to HeartLogic alert
Represents usual therapy patients receive outside the trial when HeartLogic alerts are managed via standard heart failure care
Primary use
To determine if loop diuretic adjustment normalizes or improves HeartLogic score and prevents symptom development
To assess whether afterload‑reducing therapy achieves HeartLogic score recovery and avoids progression to symptoms
Guideline‑directed medical therapy aims to improve long‑term heart failure outcomes including hospitalization and mortality
How it is given or performed
Loop diuretic medications are adjusted in response to HeartLogic alert under investigator‑defined protocol
Afterload‑lowering medications such as sacubitril/valsartan or hydralazine/isosorbide dinitrate are initiated or changed per protocol when alert occurs
GDMT involves ongoing use of neurohormonal inhibition drugs consistently regardless of device alert status
Evidence status
Mechanistic rationale but clinical effectiveness for alert‑guided diuretic adjustment not yet established
Potential benefit hypothesized but not yet validated in this alert‑based context
Strong long‑term evidence supports reduced hospitalization and mortality with GDMT
Important risks
Risks may include renal dysfunction, electrolyte imbalance, hypotension
Possible risks include symptomatic hypotension, renal impairment, angioedema (for sacubitril/valsartan)
GDMT classes can carry risks such as hyperkalaemia, renal function decline, hypotension, and drug‑specific side effects
Important limitations
Effect on long‑term outcomes beyond HeartLogic recovery is unknown
Unclear whether afterload reduction improves long‑term heart failure outcomes based solely on alert guidance
Not studied in the alert‑guided setting and may not address immediate HeartLogic alerts
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
Who Can Participate
Age: 19Years +
All Genders
Eligibility Criteria
You may qualify if you...
Have a Boston Scientific device with HeartLogic enabled
No history of ACE-inhibitor or ARB induced angioedema
No low blood pressure or low blood volume (hypotension, hypovolemia)
No renal artery stenosis or renal failure
No high potassium levels (hyperkalemia)
No severe liver disease (Child-Pugh class C)
Not pregnant or breastfeeding
No standard contraindications to diuretic therapy
Systolic blood pressure greater than 105
You will not qualify if you...
Glomerular filtration rate less than 25 mL/min and non-responsive to diuretics or on chronic dialysis
Current symptoms of heart failure worsening (increased shortness of breath or fatigue)
Recent significant change in arrhythmia burden within past 2 weeks
Recent change in delivery of cardiac resynchronization therapy within past 60 days
Unable or unwilling to sign informed consent
Symptomatic heart failure at rest or New York Heart Association Class IV at enrollment
Implanted with unipolar right atrial or right ventricular leads
Received or scheduled for heart transplant or ventricular assist device within 6 months
Pregnant or planning pregnancy during study
Regularly scheduled intravenous heart failure therapy (e.g., inotropes or diuretics)
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 90 days
Participants who have a HeartLogic score elevation without symptoms are randomized to receive either diuretic therapy, afterload reduction therapy, or observation. Treatment involves adjusting medications based on current therapies to manage worsening heart failure.
Visits at 7, 30, 60, and 90 days
Follow-up
Duration - Up to 90 days
Participants are monitored for recovery from the HeartLogic alert, symptom development, and heart failure events during the follow-up period after treatment adjustments.
Visits at 30, 60, and 90 days
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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Published Research Related To This Trial
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.
Adrian F Hernandez, Nancy M Albert, Larry A Allen...