Monitoring heart failure patients using a pulmonary artery pressure sensor
CardioMEMS Registry of the Frankfurt Heart Failure Center
This study is testing if using a special sensor to monitor heart failure patients from home can improve their health and quality of life over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Johann Wolfgang Goethe University Hospital Academic / other |
| Locations | 2 sites (Frankfurt am Main and 1 other locations) |
| Trial ID | NCT03020043 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the long-term outcomes of patients with New York Heart Association Class III heart failure who are monitored remotely using a pulmonary artery pressure sensor system known as CardioMEMS. The study involves collecting routine heart failure parameters, lab values, medication adherence, and quality of life data from patients participating in a multicentric registry in Germany. The goal is to assess the impact of telemonitoring on mortality, morbidity, and overall quality of life, as well as adherence to guideline-recommended heart failure medications.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with Class III heart failure who have successfully undergone implantation of the CardioMEMS device.
Not a fit: Patients who are unwilling to participate in the registry will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of heart failure patients, potentially reducing mortality and enhancing quality of life.
How similar studies have performed: Other studies have shown promising results with telemonitoring approaches in heart failure management, suggesting potential for success in this study as well.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Implantation of CardioMEMS successful * Telemonitoring according to the SOP of the Frankfurt Heart Failure Center (Goethe University) Exclusion Criteria: * Unwillingness to participate in the registry
Where this trial is running
Frankfurt am Main and 1 other locations
- Klinikum Goethe University — Frankfurt am Main, Germany (Recruiting)
- University Hospital Justus-Liebe University — Gießen, Germany (Not_yet_recruiting)
Study contacts
- Principal investigator: Birgit Assmus, MD — Klinikum Goethe University Frankfurt
- Study coordinator: Birgit Assmus, MD
- Email: birgit.assmus@kgu.de
- Phone: +49 69 6301
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.