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NCT03959579
The "no Biopsy Approach" for Heart Transplantation Follow-up
trial testing systematic endomyocardial biopsy. in Cardiac Transplant Rejection in 269 participants. Completed in 31 March 2018.
31 March 2018
Quick facts
| Lead sponsor | Centre Chirurgical Marie Lannelongue |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 269 |
| Start date | 22 November 2017 |
| Primary completion | 31 March 2018 |
| Estimated completion | 31 March 2018 |
| Sites | 1 location across France |
Drugs / interventions tested
- systematic endomyocardial biopsy.
Conditions studied
- Cardiac Transplant Rejection — all drugs for Cardiac Transplant Rejection →
Sponsor
Centre Chirurgical Marie Lannelongue — full company profile →
Who can join
Eligibility, any sex, with Cardiac Transplant Rejection. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Pathological analysis is the gold standard for diagnosis of acute allograft rejection after heart transplantation (HTx). This method requires repeated endomyocardial biopsies during the first post-operative year. However the sensitivity of endomyocardial biopsy (EMB) is not perfect and can be associated with major complications including fatal tamponade. Moreover, repeated biopsies are associated with reduced quality of life for HTx recipients. Since almost 20 years, the investigators do not perform routinely EMB for acute rejection screening. Early left ventricular diastolic dysfunction was investigated according to a standardized protocol. The investigators sought to analyze the long-term post-transplant outcomes without systematic EMB. The investigators hypothesize that exclusive echographic screening was not associated with impaired outcomes.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03959579
- Europe PMC full search
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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 NCT03959579 (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 Chirurgical Marie Lannelongue
- Last refreshed: 22 May 2019
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/NCT03959579.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing