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NCT02933437
An Observational Study Into the Variety of Electrocardiographic Responses to an Ajmaline Provocation in a Healthy Subjects. What Are the Genetic and Structural Variations Dictating This Response ?
Phase 2 trial testing Ajmaline in Brugada Syndrome in 100 participants. Status unknown.
1 December 2019
Quick facts
| Lead sponsor | St George's, University of London |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 100 |
| Start date | 22 October 2017 |
| Primary completion | 1 December 2019 |
| Estimated completion | 1 December 2019 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- Ajmaline (AJMALINE) — full drug profile →
Conditions studied
- Brugada Syndrome — all drugs for Brugada Syndrome →
- Sudden Death — all drugs for Sudden Death →
Sponsor
St George's, University of London
Who can join
Adults 18 to 65, any sex, with Brugada Syndrome or Sudden Death. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
The qualitative and quantitative effects of ajmaline provocation on parameters of cardiac conduction in healthy subjects using the surface electrocardiogram
Time frame: ten minutes
The investigators will be undertaking quantitative analysis of the changes in cardiac conduction observed in the presence of ajmaline. This is measured in time intervals in milliseconds (ms) and magnitude of electrical conduction which will be expressed in millivolts (mv), but can also be expressed in millimetres (mm). The investigators will use the latter to quantify area changes which will be ex
Sponsor's own description
Standard, high lead and sodium channel provoked electrocardiograms of a healthy volunteers will be performed to observe the various ECG changes. Participants will the undergo detailed imaging with cardiac magnetic resonance imaging and deep genotyping to identify structural or genetic variants which might dictate the electrocardiographic patterns at rest and with sodium channel provocation.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT02933437
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Related trials
Other trials of Ajmaline
Trials testing the same drug.
- NCT04580992 — Defining the Electrocardiographic Effect of Propofol on the Ajmaline Provocation Drug Challenge: A Prospective Trial · unknown
- NCT02641431 — Epicardial Ablation in Brugada Syndrome · NA · completed
Other recruiting trials for Brugada Syndrome
Currently open trials in the same condition.
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- NCT05643209 — Brugada Syndrome Substrate Characterization and Ablation · NA · recruiting
- NCT05521451 — Clinical Cohort Study - TRUST · recruiting
- NCT05685134 — Epicardial Radiofrequency Catheter Ablation in Patients With Brugada Syndrome · NA · active not recruiting
- NCT03775954 — Fetal Electrophysiologic Abnormalities in High-Risk Pregnancies Associated With Fetal Demise · recruiting
Other St George's, University of London trials
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 NCT02933437 (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 St George's, University of London
- Last refreshed: 4 November 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/NCT02933437.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing