https://doi.org/10.55788/b6f0d071
The Cordella PA Sensor System is a PAP-guided HF management system for patients with HF. The PROACTIVE-HF trial (NCT04089059) evaluated outcomes of this type of remote management, which provides access to body weight, blood pressure, heart rate, blood oxygen saturation, PAP, and HF symptoms [1]. PROACTIVE-HF skipped a predesigned standard-of-care control arm to become a single-arm, open-label trial with blinded endpoint assessment.
The primary cohort consisted of 465 participants with HF and NYHA class III symptoms, recent HF hospitalisation, and/or elevated NT-proBNP. The primary effectiveness endpoint was the 6-month incidence of HF hospitalisation or all-cause mortality. The performance goal was derived from the results of previous haemodynamic-monitoring trials.
All criteria for primary effectiveness success were met. The event rate was less than the performance goal: 0.15 versus 0.43 (P<0.0001); this was also less than the event rate in a historical control group arm, which was set at 0.37.
The primary safety endpoint was 2-fold: 6-month freedom from device-related or system-related complications, met by 99.2% of participants; and freedom from pressure-sensor failure, met by 99.8%. Access to the Cordella PA Sensor System also permitted further dose titration and optimisation of HF medication. Cumulatively, there were 2,956 medication changes, of which 69% were for diuretics, 27% guideline-directed medical therapy, and 4% vasodilators. The authors believe that decreased PAP and reductions in clinical events were likely primarily driven by increased diuretic dosing, as the guideline-directed medical therapy was optimised at baseline. Clinical decision-making appeared to be steered mainly by PAP.
- Kiernan MS, et al. A prospective, multi-center, open label, single arm clinical trial evaluating the safety and efficacy of the Cordella PA Sensor System in NYHA class III heart failure patients. Late breaking clinical trials: devices, Heart Failure 2024, 11–14 May, Lisbon, Portugal.
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Table of Contents: HFA 2024
Featured articles
Meet the Trialist: Innovating cardiac monitoring with MONITOR-HF
Trials: Pharmacology
Effects of semaglutide on MACE irrespective of HF status
SEQUOIA-HCM: Aficamten demonstrates clinical efficacy in obstructive HCM
ARIES-HM3 trial: Subgroup analysis in patients with prior need for aspirin
Three diuretic regimens compared in the DEA-HF study
Adding a mineralocorticoid receptor modulator in heart failure with CKD
SGLT2 Inhibitors
Empagliflozin did not reduce mortality for HF after MI regardless of T2D status
SGLT2 inhibitors decrease atrial fibrillation risk in patients with HFrEF
SGLT2 inhibition: Major and early impact on heart failure hospitalisation risk
Trials: Other
Individualised diuretic titration in acute HF without a physician
Intravenous iron deficiency treatment improves exercise capacity in patients with HFpEF
CD34+ stem cells promote reverse cardiac remodelling after acute MI
Registries
Sex-specific outcomes and resource utilisation after HF hospitalisation
Application of guideline-directed medical therapy in patients with HFrEF in the Netherlands
Devices
PAP-guided management system appears safe in patients with HF
Delivery of CRT guided by non-invasive anatomy assessment
RELIEVE-ing HFrEF with interatrial shunting
Miscellaneous
Algorithm-based remote patient monitoring was associated with lower mortality in a retrospective cohort study
High mortality and morbidity in suspected de novo HF in outpatient care
Bio-ADM as a marker for congestion in patients hospitalised for acute HF
Hypertonic saline not effective in ambulatory patients with heart failure?
No effect of low-dose carperitide on mortality or hospitalisation in acute HF
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