Remote Monitoring and Optimization of Heart Failure Therapy

The REMODEL-HF study is a prospective, multi-center, randomized, open-label clinical investigation designed to evaluate whether the use of HFMS in addition to usual care improves clinical outcomes in patients recently hospitalized for acute heart failure.

Approximately 800 participants will be enrolled and randomized in a 1:1 ratio to either: standard of care alone (control group), or standard of care plus HFMS-guided management (intervention group).

The primary objective is to determine whether HFMS-guided management results in improved overall clinical outcomes compared to usual care. Outcomes of interest include major clinical events such as cardiovascular death and heart failure hospitalization, as well as earlier indicators of clinical deterioration and changes in relevant biomarkers.

Inclusion criteria

• Age ≥18 years
• Ability and willingness to provide written informed consent and comply with study procedures
• Hospital admission for acute heart failure with dyspnea at rest and pulmonary congestion on chest X-ray, and other signs and/or symptoms of heart failure such as edema and/or positive rales on auscultation.
• All measures within 24 hours prior to randomization of systolic blood pressure ≥ 100 mmHg, and of heart rate ≥ 60 bpm.
• All measures within 24 hours prior to randomization of serum potassium ≤ 5.5 mEq/L (mmol/L).
• Biomarker criteria for persistent congestion:

• NT-proBNP >1500 pg/mL at the time of admission, and;
• NT-proBNP >1000 pg/mL >=3 days after initial admission measure
• At 1 week prior to admission, either (a) ≤ ½ the optimal dose of ACEi/ARB/ARNi (see Table) prescribed, no beta-blocker prescribed, and ≤ ½ the optimal dose of MRA prescribed or (b) no ACEi/ARB/ARNi prescribed, ≤ ½ the optimal dose of beta-blocker prescribed, and ≤ ½ the optimal dose of MRA prescribed. All study participants prescribed per label and commercially fit with the HFMS device will be eligible for enrollment.

Exclusion criteria

• Age < 18 years
• Clearly documented intolerance to high doses (≥50% of target dose) of beta-blockers.
• Clearly documented intolerance to high doses (≥50% of target dose) of RAS blockers (both ACEi and ARB).
• Mechanical ventilation (not including CPAP/BIPAP) in the 24 hours prior to Screening.
• Significant pulmonary disease contributing substantially to the patients' dyspnea such as FEV1< 1 liter or need for chronic systemic or nonsystemic steroid therapy, or any kind of primary right heart failure such as precapillary pulmonary hypertension or chronic thromboembolic pulmonary hypertension.
• Cardiac surgery within 3 months prior to Screening
• Index Event (admission for AHF) triggered primarily by a correctable etiology such as significant arrhythmia (e.g., sustained ventricular tachycardia, or atrial fibrillation/flutter with sustained ventricular response >130 beats per minute, or bradycardia with sustained ventricular arrhythmia <45 beats per minute), severe anemia, acute coronary syndrome, pulmonary embolism, planned admission for device implantation or severe nonadherence leading to very significant fluid accumulation prior to admission and brisk diuresis after admission. Troponin elevations without other evidence of an acute coronary syndrome are not excluded.
• Uncorrected thyroid disease, active myocarditis, or known amyloid, sarcoidosis, or hypertrophic obstructive cardiomyopathy.
• History of heart transplant or on a transplant list, or using or planned to be implanted with a ventricular assist device.
• Adhesive allergy/sensitivity (e.g., acrylic adhesives).
• Compromised skin at the device application site (wound, severe dermatitis, etc.) .
• Having a prescribed wearable cardioverter defibrillator
• Pulmonary artery pressure implant (e.g. CardioMems)
• Expected survival <1 year