PMID- 36191758
OWN - NLM
STAT- MEDLINE
DCOM- 20230222
LR  - 20230314
IS  - 1532-8414 (Electronic)
IS  - 1071-9164 (Linking)
VI  - 29
IP  - 2
DP  - 2023 Feb
TI  - Rationale and Design of the Proactive-HF Trial for Managing Patients With NYHA 
      Class III Heart Failure by Using the Combined Cordella Pulmonary Artery Sensor 
      and the Cordella Heart Failure System.
PG  - 171-180
LID - S1071-9164(22)00721-7 [pii]
LID - 10.1016/j.cardfail.2022.09.006 [doi]
AB  - BACKGROUND: Optimizing guideline-directed medical therapy (GDMT) and monitoring 
      congestion in patients with heart failure (HF) are key to disease management and 
      preventing hospitalizations. A pulmonary artery pressure (PAP)-guided HF 
      management system providing access to body weight, blood pressure, heart rate, 
      blood oxygen saturation, PAP, and symptoms, may provide new insights into the 
      effects of patient engagement and comprehensive care for remote GDMT titration 
      and congestion management. METHODS: The PROACTIVE-HF study was originally 
      approved in 2018 as a prospective, randomized, controlled, single-blind, 
      multicenter trial to evaluate the safety and effectiveness of the Cordella PAP 
      Sensor in patients with HF and with New York Heart Association (NYHA) functional 
      class III symptoms. Since then, robust clinical evidence supporting PAP-guided HF 
      management has emerged, making clinical equipoise and enrolling patients into a 
      standard-of-care control arm challenging. Therefore, PROACTIVE-HF was changed to 
      a single-arm trial in 2021 with prespecified safety and effectiveness endpoints 
      to provide evidence for a similar risk/benefit profile as the CardioMEMS HF 
      System. CONCLUSION: The single-arm PROACTIVE-HF trial is expected to further 
      demonstrate the benefits of PAP-guided HF management of patients with NYHA class 
      III HF. The addition of vital signs, patient engagement and self-reported 
      symptoms may provide new insights into remote GDMT titration and congestion 
      management.
CI  - Copyright (c) 2022 The Author(s). Published by Elsevier Inc. All rights reserved.
FAU - Guichard, Jason L
AU  - Guichard JL
AD  - Department of Medicine, Division of Cardiology, Section for Advanced Heart 
      Failure, Pulmonary Hypertension, and Mechanical Circulatory Support, Prisma 
      Health-Upstate, Greenville, South Carolina, United States.
FAU - Cowger, Jennifer A
AU  - Cowger JA
AD  - Department of Medicine, Division of Cardiology, Henry Ford Health, Detroit, 
      Michigan, United States.
FAU - Chaparro, Sandra V
AU  - Chaparro SV
AD  - Miami Cardiac and Vascular Institute, Division of Cardiology, Baptist South 
      Florida, Miami, Florida, United States.
FAU - Kiernan, Michael S
AU  - Kiernan MS
AD  - Department of Medicine, Division of Cardiology, Tufts Medical Center, Boston, 
      Massachusetts, United States.
FAU - Mullens, Wilfried
AU  - Mullens W
AD  - Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium.
FAU - Mahr, Claudius
AU  - Mahr C
AD  - Department of Medicine, Division of Cardiology, University of Washington, 
      Seattle, Washington, United States.
FAU - Mullin, Chris
AU  - Mullin C
AD  - NAMSA, Product Development Strategy, Saint Paul, Minnesota, United States.
FAU - Forouzan, Omid
AU  - Forouzan O
AD  - Clinical Development, Endotronix, Lisle, Chicago, Illinois, United States.
FAU - Hiivala, Nicholas J
AU  - Hiivala NJ
AD  - Clinical Development, Endotronix, Lisle, Chicago, Illinois, United States.
FAU - Sauerland, Andrea
AU  - Sauerland A
AD  - Clinical Development, Endotronix, Lisle, Chicago, Illinois, United States.
FAU - Leadley, Katrin
AU  - Leadley K
AD  - Endotronix, Lisle, Chicago, Illinois, United States.
FAU - Klein, Liviu
AU  - Klein L
AD  - Advanced Heart Failure Comprehensive Care Center and Division of Cardiology, 
      University of California San Francisco, San Francisco, California, United States. 
      Electronic address: Liviu.Klein@ucsf.edu.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20220930
PL  - United States
TA  - J Card Fail
JT  - Journal of cardiac failure
JID - 9442138
SB  - IM
MH  - Humans
MH  - *Pulmonary Artery
MH  - Prospective Studies
MH  - Single-Blind Method
MH  - *Heart Failure/drug therapy
MH  - Blood Pressure
OTO - NOTNLM
OT  - 6-minute walk test
OT  - GDMT
OT  - Remote patient monitoring
OT  - clinical trial
OT  - heart failure
COIS- Conflicts of Interest Omid Forouzan, Nicholas J. Hiivala, Andrea Sauerland, and 
      Katrin Leadley are employees of Endotronix. All other authors report no financial 
      relationships or conflicts of interest regarding the content herein.
EDAT- 2022/10/04 06:00
MHDA- 2023/02/22 06:00
CRDT- 2022/10/03 19:26
PHST- 2022/08/31 00:00 [received]
PHST- 2022/09/20 00:00 [revised]
PHST- 2022/09/20 00:00 [accepted]
PHST- 2022/10/04 06:00 [pubmed]
PHST- 2023/02/22 06:00 [medline]
PHST- 2022/10/03 19:26 [entrez]
AID - S1071-9164(22)00721-7 [pii]
AID - 10.1016/j.cardfail.2022.09.006 [doi]
PST - ppublish
SO  - J Card Fail. 2023 Feb;29(2):171-180. doi: 10.1016/j.cardfail.2022.09.006. Epub 
      2022 Sep 30.