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Tests treatment safety and results for Heart Failure
Official title Tolerability and Safety of CARDIOMEMS™ Intracardiac Continuous Cardiac Hemodynamic Monitoring Device in Patients with Cardio Renal Syndrome with Severe Renal Impairment
ClinicalTrials.gov ID: NCT05428631
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- Patient with class NYHA III heart failure having been hospitalized in the previous 12 months for cardiac decompensation (the current indication for...
- 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.
You likely can't join if
- 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).
See the full eligibility 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...
- 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...
- 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 treatment study, or has participated in another treatment 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.
The study team makes the final eligibility decision.
Where it's taking place
- Nîmes, Gard, France
- Montpellier, France
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nîmes, Gard, France; Montpellier, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.