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NCT05428631: CARDIOMEMS
Tolerability and Safety of CARDIOMEMS™ Intracardiac Continuous Cardiac Hemodynamic Monitoring Device in Patients with Cardio Renal Syndrome with Severe Renal Impairment
NA trial testing Implantation of the CARDIOMEMS™ HF device in Heart Failure in 10 participants. Currently enrolling.
26 August 2026
Quick facts
| Lead sponsor | Centre Hospitalier Universitaire de Nīmes |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 10 |
| Start date | 26 August 2022 |
| Primary completion | 26 August 2026 |
| Estimated completion | 26 August 2027 |
| Sites | 2 locations across France |
Drugs / interventions tested
- Implantation of the CARDIOMEMS™ HF device
Conditions studied
- Heart Failure — all drugs for Heart Failure →
- Renal Insufficiency — all drugs for Renal Insufficiency →
Sponsor
Centre Hospitalier Universitaire de Nīmes
Who can join
Adults 18 to 85, any sex, with Heart Failure or Renal Insufficiency. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05428631
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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- NCT07263035 — Urine Sodium-Driven Diuretic Adjustment Strategy in Acute Decompensated Heart Failure · Phase 4 · recruiting
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Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05428631 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Centre Hospitalier Universitaire de Nīmes
- Last refreshed: 10 December 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05428631.
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