Managing Congestion in Heart Failure: Pressure- and Volume- Based. A Mechanistic Study in Patients With HFpEF (MAGIC-HF)

Heart failure with preserved ejection fraction (HFpEF) remains a major clinical challenge, with high hospitalization and readmission rates that contribute to substantial healthcare costs. Achieving and maintaining euvolemia is a key goal in the management of heart failure (HF), but current methods of monitoring congestion are suboptimal. Clinical signs and symptoms often occur late and are neither sensitive nor specific for detecting early decompensation. Furthermore, traditional reliance on pressure measurements alone, such as pulmonary artery pressures, has been questioned, since elevated pressure may coexist with euvolemia or hypovolemia.

The MAGIC-HF study is a prospective, mechanistic, multi centre, remote monitoring (RM) study aiming to explore the combined use of pressure- and volume-based monitoring to improve congestion management in patients with HFpEF and to better understand the relation pressure-volume in this group of patients. This study will evaluate the daily measurements of pulmonary artery pressure, collected via the CardioMEMS™ device, in conjunction with extracellular and total body water assessments obtained through a segmental bioelectrical impedance smart scale (BWA device).

Participants enrolled in the study will have an indication for CardioMEMS™ monitoring and will undergo continuous daily assessments over a 6-month follow-up period. These measurements will focus on changes in pulmonary pressure and body fluid distribution across upper extremities, lower extremities, and trunk compartments. The hypothesis is that combining pressure and volume data will allow better detection and management of congestion, reaching a euvolemic state more effectively, and ultimately improving important biomarkers such as NT-proBNP and renal function.

Baseline evaluations will include a comprehensive echocardiographic assessment: laboratory analyses (NT-proBNP, creatinine, GFR, sST2, CA-125, bio-ADM, ALAT, ASAT, complete blood count, hsCRP). Daily remote monitoring will involve CardioMEMS™ pressure recordings and smart scale assessments. Additional blood tests will be collected at days 14, 42, 90, and at the final visit.

The study aims to characterize different congestion phenotypes based on pressure-volume relationships, such as elevated pressure with hypervolemia, euvolemia, or hypovolemia. Understanding these subgroups may allow tailored management strategies. This could challenge current treatment paradigms, particularly the routine use of diuretics based solely on pressure readings.