InnaMed TeleLab Platform

Clinicians strive to decrease hospitalization and mortality rates for heart failure (HF) patients by prescribing trial-proven drug regimens, but face complex decision-making challenges in 1) balancing prescriptions for multiple drug classes and 2) optimizing drug doses and frequencies in treatment strategies which need to be individualized for each patient. All classes of drugs recommended for guidelines-directed medical therapy (GDMT) may cause hypotension or impact renal status by worsening renal function (WRF) and/or electrolyte disorders. Therefore, prescribing any drug or increasing dosage not only adds new potential for precipitating such adverse effects but may also perturb a difficult-to-achieve balance among drugs already in the regimen, thereby jeopardizing existing hemodynamic stability and possibly inducing need for additional compensatory titration in their dosing. Monitoring for these adverse events during a patient's adaptation to any drug change is a core recommendation of GDMT and must also be patient-tailored given their idiosyncratic occurrence. In the home care setting, patients may use devices that measure blood pressure and electronically transmit data to clinicians. However, a critical gap in home monitoring currently exists for renal safety since no available patient-operated device can measure blood levels of renal function and electrolyte parameters and transmit results digitally to care providers. Thus, this information gap may hinder prescribing practices since the real-world concern for renal safety is high for most individuals with HF and comorbidities, in comparison to the relative frequency of adverse renal events observed in studies following HF outpatients. To optimize HF outcomes, the guidelines include recommendations to: 1) add a mineralocorticoid receptor antagonist (MRA); 2) switch to an angiotensin receptor neprilysin inhibitor (ARNI) from angiotensin-converting enzyme inhibitor/angiotensin receptor blocker (ACEI/ARB); and 3) titrate diuretics (e.g., loop and/or thiazide/thiazide-like), and also to achieve trial-proven daily target dose (TD), or an individual's maximum tolerated dose (MTD), for each drug class. All of these drug classes may cause elevations in creatinine (Cr) and/or blood urea nitrogen (BUN) levels, which may either be transient, i.e., associated with reversible fluctuations in renal perfusion, or indicative of renal injury, i.e., impaired glomerular function that may be permanent. Thus, while any rise in Cr is worrisome, monitoring of serial Cr levels is critical to assess risk for WRF and to guide decision-making, with testing frequency proportional to the number and magnitude of prescribed drug changes. These drugs may also cause disorders in the blood levels of potassium (K+) i.e., hyperkalemia or hypokalemia, and/or sodium (Na+), i.e., hyponatremia, which may have immediate and/or fatal dysrhythmic or neurologic consequences. The lack of availability of frequent and convenient blood testing and rapid reporting of these parameters in the usual care for outpatients may be a contributor to renal safety concerns that may limit provider adherence (i.e., "clinician inertia") to GDMT recommendations. Self-care and self-management are longstanding priorities for the HF clinical community and include coordination with providers for proper home administration of drug and dosing regimens. However, renal safety monitoring (RSM) still currently requires engagement with the health system or freestanding laboratory facilities, which may hinder the frequency and/or timeliness of blood testing to guide medication changes and/or dose titration. The InnaMed TeleLab is a novel blood testing device enabling at-home measurement of BUN, Cr, Na+, and K+ to help clinicians remotely assess renal status to safely prescribe additional drugs and up-titrate daily doses to increase GDMT adherence for HF patients.

More »