Tolerability and Safety of CARDIOMEMS™ Intracardiac Continuous Cardiac Hemodynamic Monitoring Device in Patients with Cardio Renal Syndrome with Severe Renal Impairment
Recruiting · NCT05428631 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
Inclusion criteria
- Patient with class NYHA III heart failure having been hospitalized in the previous 12 months for cardiac decompensation (the current indication for the CARDIOMEMS™ system), right heart failure or biventricular heart failure with the definition of TAPSE\<15mm and/or SDTI\<9.5cm/s regardless of LVEF, 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 greater than 7 mm in diameter.
- The patient has been informed of the study set-up, objectives, constraints and patient rights.
- The patient must have given free and informed consent and signed the consent form.
- The patient must be affiliated or a beneficiary of a health insurance plan. Precautions: if the patient is on anticoagulant therapy, an International Normalized Ratio \<1.5 is recommended before right heart catheterization and any implantation procedure
Exclusion criteria
- Patients with a contraindication to the CARDIOMEMS™ HF system (pulmonary embolism with sequelae, artery less than 7 mm, active infection).
- Patients already on renal replacement therapy.
- Patients with a history of acute venous thrombosis.
- Patients unable to tolerate right heart catheterization.
- Patients with a major cardiovascular event (i.e., myocardial infarction, stroke) within 2 months of the initial examination.
- Patients with congenital heart disease or mechanical right heart valve(s).
- Patients with known hypersensitivity or allergy to aspirin and/or clopidogrel.
- Patients with a body mass index \>35. Measure the patient's chest circumference at the armpit: if the patient's chest circumference is \> 165 cm, the sensor should not be implanted.
- Patients unable to take dual anti-platelet therapy or anticoagulant therapy for one month after implantation
- Patient hypersensitive or allergic to iohexol.
- Patient is participating in another Class I interventional study, or has participated in another interventional study within the last 3 months.
- Patient is in an exclusion period determined by a previous study.
- Patient is under guardianship, conservatorship, or conservatorship.
- The patient refuses to sign the consent form.
- It is impossible to give the patient informed information.
- The patient is pregnant or nursing.
Where it is running
2 locations listed.
- CHRU de Montpellier - Hôpital Arnaud de Villeneuve - Montpellier, France
- Centre Hospitalier Universitaire de Nîmes - Nîmes, Gard, France