Not a traditional drug phase: Pacing for Calcium Release Deficiency Syndrome (CRDS)
Calcium Release Deficiency Syndrome (CRDS) is a novel inherited arrhythmia syndrome secondary to RyR2 loss-of-function that confers a risk of sudden cardiac death. Diagnosis of CRDS presently requires cellular-based in vitro confirmation that an RyR2 variant causes loss-of-function.
Official registry: https://clinicaltrials.gov/study/NCT06188689 · Population Health Research Institute · enrollment listed as 400
What this phase means
This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Pacing. The registry lists allocation as na. Calcium Release Deficiency Syndrome (CRDS) is a novel inherited arrhythmia syndrome secondary to RyR2 loss-of-function that confers a risk of sudden cardiac death.
They plan to enroll about 400 people at 21 sites. Taking part typically means study visits and measurements plus check-ins.
Official title (unrewritten)
Evaluation of a Clinical Diagnostic Test for Calcium Release Deficiency Syndrome: The DIAGNOSE CRDS Study
Interventions: Pacing
Primary outcome (registry wording): ΔT-wave amplitude value
Who it is for (from inclusion criteria)
- Cohort 1: Calcium Release Deficiency Syndrome (CRDS) Cases
- Presence of an RyR2 variant confirmed to be loss-of-function on in vitro testing
Who the registry excludes
- Cohort 2: Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT) Cases
- who can join:
- Satisfy a clinical phenotype consistent with the Expert Consensus Statement
- Presence of a confirmed or presumed pathogenic gain-of-function RyR2 variant OR homozygous or compound heterozygous for likely pathogenic/pathogenic CASQ2 variants
Public study contact (from the registry)
Jason Roberts, MD MAS
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
21 listed- University of California — San Francisco, California (recruiting)
- Boston Children's Hospital — Boston, Massachusetts (recruiting)
- Mayo Clinic — Rochester, Minnesota (recruiting)
- University of Washington — Seattle, Washington (recruiting)
+ 17 sites outside the US on the same record
FAQ about this NCT record
Is NCT06188689 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT06188689?
Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT06188689?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary