Last reviewed · How we verify
NCT05563376
Fontan-Sprechstunde
NA trial testing Univentricular Hearts in Univentricular Heart in 200 participants. Currently enrolling.
1 September 2031
Quick facts
| Lead sponsor | University of Erlangen-Nürnberg Medical School |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 200 |
| Start date | 1 September 2020 |
| Primary completion | 1 September 2031 |
| Estimated completion | 1 September 2041 |
| Sites | 1 location across Germany |
Drugs / interventions tested
- Univentricular Hearts
Conditions studied
- Univentricular Heart — all drugs for Univentricular Heart →
Sponsor
University of Erlangen-Nürnberg Medical School
Who can join
Adults 6 to 60, any sex, with Univentricular Heart. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
After successful Fontan surgery, the risk of mortality in childhood is only low. Unfortunately, some of the patients suffer from Fontan-typical long-term complications in the long-term course, whereby protein loss neuropathy must be mentioned in particular, which is described in the literature with an incidence of 3-14% (1, 2) and still has a 5-year risk of death of 6-12% today (2, 3). Protein loss tereopathy leads to loss of protein in the intestine and subsequently to diarrhea and edema. Other problems concern the liver, which can develop cirrhosis due to chronic congestion (4-6). Cardiac can lead to heart failure and arrhythmias. The registry study described in this protocol is intended to identify factors that influence the treatment outcome of patients in the Fontan circulation in the long term through systematic prospective documentation of the data from our standardized and guideline-oriented treatment.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05563376
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Related trials
Other recruiting trials for Univentricular Heart
Currently open trials in the same condition.
- NCT06735521 — Cardiac Magnetic Resonance Stress-perfusion Study in Patinets with Fontan Circulation · recruiting
- NCT05744934 — Interstage Monitoring Using an Implantable Loop Recorder: A Pilot Study · EARLY_PHASE1 · recruiting
- NCT05620030 — Prospective Evaluation of Univentricular Hearts · NA · recruiting
Other University of Erlangen-Nürnberg Medical School trials
Trials by the same sponsor.
- NCT06969820 — Establishment and Evaluation of Standardized Clinical, Biological and Imaging Parameters to Assess the Response of LDRT · not yet recruiting
- NCT07406191 — WB-EMS Effects on Cardiometabolic Risk Factors · NA · recruiting
- NCT07352540 — Single vs Triple Hyaluronic Acid in Knee Osteoarthritis · Phase 2, PHASE3 · not yet recruiting
- NCT07313878 — Evaluation of Acute and Chronic Nephrotoxicity in Acute Lymphatic Leukemia Patients Using Ultrasound Localization Micros · NA · recruiting
- NCT07121985 — Multispectral Optoacoustic Imaging for the Detection of Inflammation and Damage of Peripheral Nerves in Guillain-Barré S · not yet recruiting
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 NCT05563376 (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 University of Erlangen-Nürnberg Medical School
- Last refreshed: 3 October 2022
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/NCT05563376.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing