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Study identifier: NCT05428631 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Tolerability and Safety of CARDIOMEMS™ Intracardiac Continuous Cardiac Hemodynamic Monitoring Device in Patients with Cardio Renal Syndrome with Severe Renal Impairment

Condition: Heart Failure · Renal Insufficiency  ·  Sponsor: Centre Hospitalier Universitaire de Nīmes

PhaseNA
Planned participants10
Who can joinAll sexes, 18 Years to 85 Years
Healthy volunteersNo

About this study

Renal failure is present in 40% of heart failure patients, and is one of the main comorbidities of heart failure. Follow-up with pulmonary artery pressure (PAP) monitoring has shown a reduction in mortality and frequency of hospitalization in patients with heart failure alone in the CHAMPION trial. Patients with New York Heart Association class III heart failure and a hospitalization in the previous 12 months were included in that study. They benefited from the "CardioMEMS™ HF" device with a sensor implanted in the pulmonary artery to measure PAP. According to that study, the information led to more precise and early adaptation of therapy by avoiding the onset of heart failure symptoms and reducing the number of hospitalizations. However, in that study, patients with impaired renal function (Glomerular Filtration Rate\<25 mL/min/1.73m2) were excluded, limiting the indication for treatment in those patients, and the evolution of renal function during the study was not reported. Patients with heart failure AND advanced renal failure are defined as having a cardio-renal syndrome, with strong interaction between these 2 organs. In the event of predominant right heart failure, they may require treatment by renal replacement or dialysis. There seems to be a link between high venous pressure, renal repercussions and the need for dialysis. Additional follow-up data in this clinical situation are needed to confirm this link and to suggest the interest of continuous PAP monitoring to …

This description comes directly from the study's public registry record.

Talk to the study team

Olivier MORANNE, Prof.  ·  +33 4.66.68.31.49  ·  olivier.moranne@chu-nimes.fr

Anissa MEGZARI  ·  +33466684236  ·  drc@chu-nimes.fr

Always discuss trial participation with your own doctor first.

Locations (2)

Centre Hospitalier Universitaire de NîmesNîmes, Gard, FranceRecruiting
CHRU de Montpellier - Hôpital Arnaud de VilleneuveMontpellier, FranceRecruiting

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Source record: clinicaltrials.gov/study/NCT05428631