Hemodynamic-GUIDEd management of Heart Failure (GUIDE-HF)

Abstract

In that study, incremental reductions in the PA pressures in the monitored arm were associated with both reduction in the frequency of HFH and improvements in health-related quality of life among patients with both preserved (HFpEF) and reduced ejection fraction (HFrEF).3,4 Additionally, hemodynamic-guided HF management in the subset of HFrEF patients treated with guideline-directed medical therapy (GDMT) was associated with a strong trend toward improved survival compared to traditional clinical management.4,7 Consistent benefit is demonstrated in several retrospective studies from the CHAMPION Trial.10-13 as well as extensive analysis of “real-world” experience.6,14 and in Medicare claims data managed in a commercial setting.5,15 Whether the benefits of PA pressure guided therapy can be extended to a broader pool of patients with milder (NYHA class II) or more severe (NYHA class IV) HF or to those without recent hospitalization for HF but with elevation in natriuretic peptide levels remains unclear. Remotely uploaded PA pressure information from the control group will be blocked from investigator review. [...]other than medication changes resulting from information from RHC procedures, control group subjects will not have pressure-based medication changes over time and should be managed instead according to routine practice as informed by published clinical guidelines. Thresholds for NT-proBNP/BNP corrected for BMI using a 4% reduction per BMI unit over 25 kg/m2 Subjects ≥18 y of age able and willing to provide informed consent Chest circumference of <65 in if BMI is ≥35 kg/m2 Willing and able to upload PA pressure information and comply with the follow-up requirements Exclusion criteria Intolerance to all neurohormonal antagonists (ie, intolerance to ACE-I, ARB, ARNi, hydralazine/isosorbide dinitrate, and β-blockers) ACC/AHA stage D refractory HF (including having received or currently receiving pharmacologic circulatory support with inotropes) Received or are likely to receive an advanced therapy (eg, mechanical circulatory support or cardiac transplant) in the next 12 m NYHA class IV HF patients with: continuous or chronic use of scheduled intermittent inotropic therapy for HF and an INTERMACS level of ≤4, or persistence of fluid overload with maximum (or dose equivalent) diuretic intervention eGFR < 25 mL/min/1.73 m2 and nonresponsive to diuretic therapy, or receiving chronic dialysis Inability to tolerate or receive dual antiplatelet therapy or anticoagulation therapy for 1 m postimplantation Significant congenital heart disease that has not been repaired and would prevent implantation of the CardioMEMS PA Sensor Implanted with mechanical right heart valve(s) Unrepaired severe valvular disease Pregnant or planning to become pregnant in the next 12 m An active, ongoing infection, defined as being febrile, an elevated white blood cell count, on intravenous antibiotics, and/or positive cultures (blood, sputum or urine). History of current or recurrent (≥2 episodes within 5 y prior to consent) pulmonary emboli and/or deep vein thromboses Major cardiovascular event (eg, unstable angina, myocardial infarction, percutaneous coronary intervention, open heart surgery, or stroke) within 90 d prior to consent Implanted with CRT-P or CRT-D for less than 90 d prior to consent Enrollment into another trial with an active treatment arm Anticipated life expectancy of <12 m Any condition that, in the opinion of the Investigator, would not allow for utilization of the CardioMEMS HF System to manage the subject using information gained from hemodynamic measurements to adjust medications, including the presence of unexpectedly severe pulmonary hypertension (eg, transpulmonary gradient >15) at implant RHC, a history of noncompliance, or any condition that would preclude CardioMEMS PA Sensor implantation Table I Inclusion and exclusion criteria PA pressure goals PA diastolic: 8-20 mm Hg PA mean: 10-25 mm Hg PA systolic: 15-35 mm Hg Optimization phase