Actively Recruiting
Tolerability and Safety of CARDIOMEMS™ Intracardiac Continuous Cardiac Hemodynamic Monitoring Device in Patients with Cardio Renal Syndrome with Severe Renal Impairment
Led by Centre Hospitalier Universitaire de Nīmes · Updated on 2024-12-10
10
Participants Needed
2
Research Sites
260 weeks
Total Duration
On this page
Sponsors
C
Centre Hospitalier Universitaire de Nīmes
Lead Sponsor
C
CHU Arnaud de Villeneuve MONTPELLIER
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 improve the management of these patients with cardio-renal syndrome with severe renal impairment defined by a Glomerular Filtration Rate\< 30 ml/min/1.73m2 (KDIGO Cardio-renal 2019). This pilot study aims to evaluate how tolerable the "CARDIOMEMS™ HF" device in patients with cardio-renal syndrome and obtain the first information on the relationship between cardiac hemodynamics and renal function in this population.
CONDITIONS
Official Title
Tolerability and Safety of CARDIOMEMS™ Intracardiac Continuous Cardiac Hemodynamic Monitoring Device in Patients with Cardio Renal Syndrome with Severe Renal Impairment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient with class NYHA III heart failure hospitalized in the previous 12 months for cardiac decompensation, right heart failure, or biventricular heart failure with TAPSE <15mm and/or SDTI <9.5cm/s regardless of LVEF, and NtproBNP >1500 pg/ml
- Patient with advanced renal failure with GFR (CKD-EPI) < 30 ml/min/1.73m2 for more than 3 months confirmed by GFR measurement (Iohexol clearance)
- Patient with a pulmonary artery diameter greater than 7 mm
- Patient informed of the study objectives, constraints, and rights
- Patient has given free and informed consent and signed the consent form
- Patient is affiliated with or beneficiary of a health insurance plan
- If on anticoagulant therapy, an International Normalized Ratio <1.5 is recommended before right heart catheterization and implantation
You will not qualify if you...
- Contraindication to the CARDIOMEMS2 HF system (pulmonary embolism with sequelae, artery less than 7 mm, active infection)
- Patients already on renal replacement therapy
- History of acute venous thrombosis
- Unable to tolerate right heart catheterization
- Major cardiovascular event within 2 months before initial examination (myocardial infarction, stroke)
- Congenital heart disease or mechanical right heart valve(s)
- Known allergy to aspirin and/or clopidogrel
- Body mass index >35 or chest circumference >165 cm
- Unable to take dual anti-platelet or anticoagulant therapy for one month after implantation
- Hypersensitive or allergic to iohexol
- Participating or recently participated (within 3 months) in another Class I interventional study
- Under guardianship, conservatorship, or similar legal protection
- Refusal or inability to provide informed consent
- Pregnant or nursing
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Centre Hospitalier Universitaire de Nîmes
Nîmes, Gard, France, 30029
Actively Recruiting
2
CHRU de Montpellier - Hôpital Arnaud de Villeneuve
Montpellier, France, 34295
Actively Recruiting
Research Team
O
Olivier MORANNE, Prof.
CONTACT
A
Anissa MEGZARI
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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