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NCT03667144: DILV-S
Survival of Double Inlet Left Ventricle Patients Without Fontan Circulation
trial in Double Inlet Left Ventricle in 15 participants. Status unknown.
1 June 2019
Quick facts
| Lead sponsor | University of Groningen |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 15 |
| Start date | 3 December 2018 |
| Primary completion | 1 June 2019 |
| Estimated completion | 1 June 2019 |
Conditions studied
- Double Inlet Left Ventricle — all drugs for Double Inlet Left Ventricle →
Sponsor
University of Groningen
Who can join
12 and older, any sex, with Double Inlet Left Ventricle. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Patients with univentricular hearts are currently palliated with the Fontan procedures. This results in an unphysiologic circulation with poor long-term survival. On the other hand there is a small, selected subgroup of patients with univentricular hearts of the double inlet left ventricle (DILV) type that survives up to old age without ever having undergone any Fontan procedures. Considering the relatively bleak data on long-term survival of DILV patients palliated with the Fontan procedure, it seems highly relevant to investigate and determine factors that allow a selection of unoperated patients to live to a comparatively high age without apparent major complaints. This might have an impact on how (and if, at all) certain univentricular patients are selected for operation in the future. For some, a different surgical procedure, or even therapeutic nihilism might be a more viable alternative. The investigators hypothesise that favourable intracardiac streaming plays a role in making these patients viable: certain intracardiac anatomical characteristics allow for favourable flow patterns. The primary objective of this study is to describe the intracardiac anatomy and hemodynamics of DILV patients without Fontan circulation using 4D MRI. Furthermore, the functional status and quality of life of these patients will be assessed.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03667144
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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 NCT03667144 (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 Groningen
- Last refreshed: 12 September 2018
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/NCT03667144.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing