Calcium Release Deficiency Syndrome (CRDS)DIAGNOSE CRDSNCT06188689
Evaluation of A Clinical Diagnostic Test for CRDS
A study testing Pacing in people with Calcium Release Deficiency Syndrome (CRDS), run by Population Health Research Institute at 20 sites in 7 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Calcium Release Deficiency Syndrome (CRDS)
- What is being tested?
- Pacing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 20 sitesin 7 countries
- Study dates
- 2 Feb 2023to Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Presence of an RyR2 variant confirmed to be loss-of-function on in vitro testing
- 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
- Cardiac arrest requiring cardioversion or defibrillation that remains unexplained following an ECG, echocardiogram, coronary assessment, cardiac MRI, and exercise treadmill test
- Undergone genetic testing that includes screening of RyR2*
- Undergoing an invasive electrophysiology study
Who cannot join
- Unable to provide informed consent
- Cohort 2: Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT) Cases
- Unable to provide informed consent
- Use of a QT prolonging medication, aside from flecainide, at the time of the burst pacing maneuvers
- Cohort 3: Survivors of Unexplained Cardiac Arrest (UCA)
- Unable to provide informed consent
Show all 16Show fewer
- Use of a QT prolonging medication at the time of the burst pacing maneuvers
- Among survivors of UCA that possess a rare RyR2 variant in the absence of a CPVT phenotype, in vitro functional testing will be performed in order to confirm it is not loss- or gain-of-function (and will be arranged through the laboratory of Dr. Wayne Chen at the University of Calgary).
- Cohort 4: SVT controls
- Ventricular cardiomyopathy
- Ventricular pre-excitation
- Long QT syndrome
- Use of a QT prolonging medication at the time of the EP study
- Use of a Class I or Class III anti-arrhythmic drug at the time of the EP study
- Known obstructive coronary artery disease (existing coronary stenosis >50%)
- Unable to provide informed consent
Trial locations and contacts
20 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
20 sites in 7 countries
Canada10 sites, 10 recruiting
- Recruiting
University of Calgary
Calgary, Alberta, T2N 1N4
Project Manager, 905-521-2100, crds@phri.ca
Erkan Ilhan, MD
- Recruiting
Alberta Health Services
Edmonton, Alberta, T6G 2C8
Project Manager, 905-521-2100, crds@phri.ca
Joseph Atallah, MD CM, MSc
- Recruiting
Hamilton General Hospital
Hamilton, Ontario, L8L 2X2
Project Manager, 905-521-2100, crds@phri.ca
Jason D Roberts, MD MAS
- Recruiting
London Health Sciences Centre - University Hospital
London, Ontario, N6A 5A5
Project Manager, 905-521-2100, crds@phri.ca
Habib R Khan, MD
- Recruiting
Montréal Heart Institute
Montreal, Quebec, H1T 1C8
Project Manager, 905-521-2100, crds@phri.ca
Rafik Tadros, MD PhD
- Recruiting
Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7
Project Manager, 905-521-2100, crds@phri.ca
Simon Hansom, MD
- Recruiting
Institut Universitaire de Cardiologie et de Pneumologie de Québec-Université Laval
Québec, Quebec, G1V 4G5
Project Manager, 905-521-2100, crds@phri.ca
Christian Steinberg, MD
- Recruiting
Toronto General Hospital
Toronto, Ontario, M5G 2C4
Project Manager, 905-521-2100, crds@phri.ca
Michael H. Gollob, MD, FRCP(C)
- Recruiting
Children's & Women's Health Centre of British Columbia
Vancouver, British Columbia, V6H 3N1
Project Manager, 905-521-2100, crds@phri.ca
Shubhayan Sanatani, MD
- Recruiting
The University of British Columbia
Vancouver, British Columbia, V6T 1Z3
Project Manager, 905-521-2100, crds@phri.ca
Thomas M Roston, MD
United States4 sites, 4 recruiting
- Recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
Project Manager, 905-521-2100, crds@phri.ca
Dominic Abrams, MBBS, MD, MBA
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Project Manager, 905-521-2100, crds@phri.ca
John Giudicessi, MD, PhD
- Recruiting
University of California
San Francisco, California, 94143
Project Manager, 905-521-2100, crds@phri.ca
Vasanth Vedantham, MD, PhD
- Recruiting
University of Washington
Seattle, Washington, 98195
Project Manager, 905-521-2100, crds@phri.ca
Uyanga Batnyam, MD
Belgium2 sites, 2 recruiting
- Recruiting
Universitair Ziekenhuis Brussel
Brussels, 1090
Project Manager, 905-521-2100, crds@phri.ca
Luigi Pannone, MD
- Recruiting
Antwerp University Hospital
Edegem, Antwerp, 2650
Project Manager, 905-521-2100, crds@phri.ca
Johan Saenen, MD, PhD
Denmark1 site, 1 recruiting
- Recruiting
Aarhus University Hospital
Aarhus, DK-8200 N
Project Manager, 905-521-2100, crds@phri.ca
Henrik Jensen, MD
France1 site, 1 recruiting
- Recruiting
CHU de Bordeaux
Bordeaux, New Aquitaine, 33404
Project Manager, 905-521-2100, crds@phri.ca
Frédéric Sacher, MD
Israel1 site, 1 recruiting
- Recruiting
Shaare Zedek Medical Center
Jerusalem, 9103102
Project Manager, 905-521-2100, crds@phri.ca
Ziv Dadon, MD
United Kingdom1 site, 1 recruiting
- Recruiting
Oxford University Hospitals
Oxford, Oxfordshire, OX3 9DU
Project Manager, 905-521-2100, crds@phri.ca
Julian Ormerod, BM, Bch, FRCP
About this study
Official title: Evaluation of a Clinical Diagnostic Test for Calcium Release Deficiency Syndrome: The DIAGNOSE CRDS Study
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. We hypothesize that CRDS can be diagnosed clinically through evaluation of the repolarization response to brief tachycardia, mediated by cardiac pacing, and a subsequent pause.
Read the detailed description
RyR2 loss-of-function variants have recently been established as causative for a new disease termed calcium release deficiency syndrome (CRDS) that confers a risk of malignant ventricular arrhythmias and sudden cardiac death. RyR2 encodes the cardiac ryanodine receptor, the calcium release channel on the sarcoplasmic reticulum that mediates excitation-contraction coupling through calcium-induced calcium-release. In contrast to CRDS, pathogenic RyR2 gain-of-function variants result in an autosomal dominant form of catecholaminergic polymorphic ventricular tachycardia (CPVT). The adrenergic-mediated ventricular arrhythmias characteristic of CPVT can be readily reproduced on exercise stress testing (EST), making EST the standard clinical diagnostic tool for CPVT.
In contrast to CPVT, the CRDS clinical phenotype is concealed with standard cardiac testing tools and its diagnosis presently requires cellular-based in vitro confirmation that an RyR2 variant causes loss-of-function. Beyond the significant time delay associated with in vitro functional analysis, this testing requires specialized expertise that is not widely available and remains research-based, making it impractical for routine use in clinical care. In this overall context, it is likely that the vast majority of global CRDS cases have yet to be diagnosed.
A prior report of an "atypical CPVT" family carrying an RyR2-p.M4109R variant observed marked and transient repolarization changes following pacing mediated tachycardia and a subsequent pause. Since publication of this report, in vitro characterization of the RyR2-p.M4109R variant has confirmed its being loss-of-function and the familial diagnosis has been revised to CRDS. Driven by these observations and promising preliminary findings, the DIAGNOSE CRDS study seeks to further investigate this apparent electrocardiographic signature of CRDS following brief tachycardia and subsequent pause as a potential method to clinically diagnose the condition.
- Being tested
- Pacing
- Keywords
- cardiac arrhythmia, sudden cardiac death, cardiac ryanodine receptor, unexplained cardiac arrest
- Medical subject headings
- Arrhythmias, Cardiac, Death, Sudden, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PacingDiagnostic test
- Ventricular 10 beat burst at 500ms (120bpm)
- Ventricular 10 beat burst at 400ms (150bpm)
- Atrial 10 beat burst at 500ms (120bpm)
- Atrial 10 beat burst at 400ms (150bpm).
| Study group | Role | What they receive |
|---|---|---|
| Pacing | Experimental | Separate ventricular and atrial pacing trains will be administered at different cycle lengths and the ventricular repolarization response on the first sinus beat following the subsequent pause will be evaluated. Receives: Diagnostic Test: Pacing |
What is being measured
The primary outcome is the main question the study is designed to answer.
ΔT-wave amplitude value
T-wave amplitude on first post-pause sinus beat subtracted by the T-wave amplitude on the last sinus beat prior to pacing
Measured: At time of pacing maneuver
ΔQT value
Absolute QT value on first post-pause sinus beat subtracted by the absolute QT value on the last sinus beat prior to pacing
Measured: At time of pacing maneuver
Secondary outcomes (2)
Absolute QT value
Absolute QT value on first post-pause sinus beat
Measured: At time of pacing maneuver
Absolute T-wave amplitude
Absolute T-wave amplitude on first post-pause sinus beat
Measured: At time of pacing maneuver
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start2 Feb 2023
- Primary completionDec 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Calcium Release Deficiency Syndrome (CRDS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Population Health Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Ziv Dadon, MD, Study director, Shaare Zedek Medical CenterJason D Roberts, MD MAS, Principal investigator, McMaster UniversityWayne Chen, PhD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06188689
- Sponsor's protocol ID
- 14546
- Acronym
- DIAGNOSE CRDS
- Status last verified
- May 2026
- First submitted
- 18 Dec 2023
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sun B, Yao J, Ni M, Wei J, Zhong X, Guo W, Zhang L, Wang R, Belke D, Chen YX, Lieve KVV, Broendberg AK, Roston TM, Blankoff I, Kammeraad JA, von Alvensleben JC, Lazarte J, Vallmitjana A, Bohne LJ, Rose RA, Benitez R, Hove-Madsen L, Napolitano C, Hegele RA, Fill M, Sanatani S, Wilde AAM, Roberts JD, Priori SG, Jensen HK, Chen SRW. Cardiac ryanodine receptor calcium release deficiency syndrome. Sci Transl Med. 2021 Feb 3;13(579):eaba7287. doi: 10.1126/scitranslmed.aba7287.
PubMed 33536282Nof E, Belhassen B, Arad M, Bhuiyan ZA, Antzelevitch C, Rosso R, Fogelman R, Luria D, El-Ani D, Mannens MM, Viskin S, Eldar M, Wilde AA, Glikson M. Postpacing abnormal repolarization in catecholaminergic polymorphic ventricular tachycardia associated with a mutation in the cardiac ryanodine receptor gene. Heart Rhythm. 2011 Oct;8(10):1546-52. doi: 10.1016/j.hrthm.2011.05.016. Epub 2011 May 26.
PubMed 21699856Ormerod JOM, Ormondroyd E, Li Y, Taylor J, Wei J, Guo W, Wang R, Sarton CNS, McGuire K, Dreau HMP, Taylor JC, Ginks MR, Rajappan K, Chen SRW, Watkins H. Provocation Testing and Therapeutic Response in a Newly Described Channelopathy: RyR2 Calcium Release Deficiency Syndrome. Circ Genom Precis Med. 2022 Feb;15(1):e003589. doi: 10.1161/CIRCGEN.121.003589. Epub 2021 Dec 24.
PubMed 34949103Roston TM, Wei J, Guo W, Li Y, Zhong X, Wang R, Estillore JP, Peltenburg PJ, Noguer FRI, Till J, Eckhardt LL, Orland KM, Hamilton R, LaPage MJ, Krahn AD, Tadros R, Vinocur JM, Kallas D, Franciosi S, Roberts JD, Wilde AAM, Jensen HK, Sanatani S, Chen SRW. Clinical and Functional Characterization of Ryanodine Receptor 2 Variants Implicated in Calcium-Release Deficiency Syndrome. JAMA Cardiol. 2022 Jan 1;7(1):84-92. doi: 10.1001/jamacardio.2021.4458.
PubMed 34730774Ni M, Dadon Z, Ormerod JOM, Saenen J, Hoeksema WF, Antiperovitch P, Tadros R, Christiansen MK, Steinberg C, Arnaud M, Tian S, Sun B, Estillore JP, Wang R, Khan HR, Roston TM, Mazzanti A, Giudicessi JR, Siontis KC, Alak A, Acosta JG, Divakara Menon SM, Tan NS, van der Werf C, Nazer B, Vivekanantham H, Pandya T, Cunningham J, Gula LJ, Wong JA, Amit G, Scheinman MM, Krahn AD, Ackerman MJ, Priori SG, Gollob MH, Healey JS, Sacher F, Nof E, Glikson M, Wilde AAM, Watkins H, Jensen HK, Postema PG, Belhassen B, Chen SRW, Roberts JD. A Clinical Diagnostic Test for Calcium Release Deficiency Syndrome. JAMA. 2024 Jul 16;332(3):204-213. doi: 10.1001/jama.2024.8599.
PubMed 38900490
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Clinical Diagnostic Test for Calcium Release Deficiency Syndrome: The DIAGNOSE CRDS Study
- ClinicalTrials.gov ID
- NCT06188689
- Acronym / sponsor ID
- DIAGNOSE CRDS / 14546
- Keywords
- cardiac arrhythmia, sudden cardiac death, cardiac ryanodine receptor, unexplained cardiac arrest
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Population Health Research InstituteUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 2 Feb 2023 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 3 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. We hypothesize that CRDS can be diagnosed clinically through evaluation of the repolarization response to brief tachycardia, mediated by cardiac pacing, and a subsequent pause.
Detailed description
RyR2 loss-of-function variants have recently been established as causative for a new disease termed calcium release deficiency syndrome (CRDS) that confers a risk of malignant ventricular arrhythmias and sudden cardiac death. RyR2 encodes the cardiac ryanodine receptor, the calcium release channel on the sarcoplasmic reticulum that mediates excitation-contraction coupling through calcium-induced calcium-release. In contrast to CRDS, pathogenic RyR2 gain-of-function variants result in an autosomal dominant form of catecholaminergic polymorphic ventricular tachycardia (CPVT). The adrenergic-mediated ventricular arrhythmias characteristic of CPVT can be readily reproduced on exercise stress testing (EST), making EST the standard clinical diagnostic tool for CPVT.
In contrast to CPVT, the CRDS clinical phenotype is concealed with standard cardiac testing tools and its diagnosis presently requires cellular-based in vitro confirmation that an RyR2 variant causes loss-of-function. Beyond the significant time delay associated with in vitro functional analysis, this testing requires specialized expertise that is not widely available and remains research-based, making it impractical for routine use in clinical care. In this overall context, it is likely that the vast majority of global CRDS cases have yet to be diagnosed.
A prior report of an "atypical CPVT" family carrying an RyR2-p.M4109R variant observed marked and transient repolarization changes following pacing mediated tachycardia and a subsequent pause. Since publication of this report, in vitro characterization of the RyR2-p.M4109R variant has confirmed its being loss-of-function and the familial diagnosis has been revised to CRDS. Driven by these observations and promising preliminary findings, the DIAGNOSE CRDS study seeks to further investigate this apparent electrocardiographic signature of CRDS following brief tachycardia and subsequent pause as a potential method to clinically diagnose the condition.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pacing | Experimental | Diagnostic Test: PacingSeparate ventricular and atrial pacing trains will be administered at different cycle lengths and the ventricular repolarization response on the first sinus beat following the subsequent pause will be evaluated. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Presence of an RyR2 variant confirmed to be loss-of-function on in vitro testing
- 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
- Cardiac arrest requiring cardioversion or defibrillation that remains unexplained following an ECG, echocardiogram, coronary assessment, cardiac MRI, and exercise treadmill test
- Undergone genetic testing that includes screening of RyR2*
Key exclusion criteria (16 listed)
- Unable to provide informed consent
- Cohort 2: Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT) Cases
- Unable to provide informed consent
- Use of a QT prolonging medication, aside from flecainide, at the time of the burst pacing maneuvers
- Cohort 3: Survivors of Unexplained Cardiac Arrest (UCA)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pacing1. Ventricular 10 beat burst at 500ms (120bpm) 2. Ventricular 10 beat burst at 400ms (150bpm) 3. Atrial 10 beat burst at 500ms (120bpm) 4. Atrial 10 beat burst at 400ms (150bpm). | Diagnostic test | Pacing |
Primary outcome
ΔT-wave amplitude value
Time frame: At time of pacing maneuver
T-wave amplitude on first post-pause sinus beat subtracted by the T-wave amplitude on the last sinus beat prior to pacing
ΔQT value
Time frame: At time of pacing maneuver
Absolute QT value on first post-pause sinus beat subtracted by the absolute QT value on the last sinus beat prior to pacing
2 secondary outcomes
Absolute QT value
Time frame: At time of pacing maneuver
Absolute T-wave amplitude
Time frame: At time of pacing maneuver
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Results publication: PubMed 33536282Sun B, Yao J, Ni M, Wei J, Zhong X, Guo W, Zhang L, Wang R, Belke D, Chen YX, Lieve KVV, Broendberg AK, Roston TM, Blankoff I, Kammeraad JA, von Alvensleben JC, Lazarte J, Vallmitjana A, Bohne LJ, Rose RA, Benitez R, Hove-Madsen L, Napolitano C, Hegele RA, Fill M, Sanatani S, Wilde AAM, Roberts JD, Priori SG, Jensen HK, Chen SRW. Cardiac ryanodine receptor calcium release deficiency syndrome. Sci Transl Med. 2021 Feb 3;13(579):eaba7287. doi: 10.1126/scitranslmed.aba7287.
- Results publication: PubMed 21699856Nof E, Belhassen B, Arad M, Bhuiyan ZA, Antzelevitch C, Rosso R, Fogelman R, Luria D, El-Ani D, Mannens MM, Viskin S, Eldar M, Wilde AA, Glikson M. Postpacing abnormal repolarization in catecholaminergic polymorphic ventricular tachycardia associated with a mutation in the cardiac ryanodine receptor gene. Heart Rhythm. 2011 Oct;8(10):1546-52. doi: 10.1016/j.hrthm.2011.05.016. Epub 2011 May 26.
- Results publication: PubMed 34949103Ormerod JOM, Ormondroyd E, Li Y, Taylor J, Wei J, Guo W, Wang R, Sarton CNS, McGuire K, Dreau HMP, Taylor JC, Ginks MR, Rajappan K, Chen SRW, Watkins H. Provocation Testing and Therapeutic Response in a Newly Described Channelopathy: RyR2 Calcium Release Deficiency Syndrome. Circ Genom Precis Med. 2022 Feb;15(1):e003589. doi: 10.1161/CIRCGEN.121.003589. Epub 2021 Dec 24.
- Results publication: PubMed 34730774Roston TM, Wei J, Guo W, Li Y, Zhong X, Wang R, Estillore JP, Peltenburg PJ, Noguer FRI, Till J, Eckhardt LL, Orland KM, Hamilton R, LaPage MJ, Krahn AD, Tadros R, Vinocur JM, Kallas D, Franciosi S, Roberts JD, Wilde AAM, Jensen HK, Sanatani S, Chen SRW. Clinical and Functional Characterization of Ryanodine Receptor 2 Variants Implicated in Calcium-Release Deficiency Syndrome. JAMA Cardiol. 2022 Jan 1;7(1):84-92. doi: 10.1001/jamacardio.2021.4458.
- Derived from this study: PubMed 38900490Ni M, Dadon Z, Ormerod JOM, Saenen J, Hoeksema WF, Antiperovitch P, Tadros R, Christiansen MK, Steinberg C, Arnaud M, Tian S, Sun B, Estillore JP, Wang R, Khan HR, Roston TM, Mazzanti A, Giudicessi JR, Siontis KC, Alak A, Acosta JG, Divakara Menon SM, Tan NS, van der Werf C, Nazer B, Vivekanantham H, Pandya T, Cunningham J, Gula LJ, Wong JA, Amit G, Scheinman MM, Krahn AD, Ackerman MJ, Priori SG, Gollob MH, Healey JS, Sacher F, Nof E, Glikson M, Wilde AAM, Watkins H, Jensen HK, Postema PG, Belhassen B, Chen SRW, Roberts JD. A Clinical Diagnostic Test for Calcium Release Deficiency Syndrome. JAMA. 2024 Jul 16;332(3):204-213. doi: 10.1001/jama.2024.8599.
- Individual participant dataSharing planned: No
Related trials for Calcium Release Deficiency Syndrome (CRDS)
RecruitingObservational study
International CRDS Registry
Calcium Release Deficiency Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ziv Dadon, MD study director
Shaare Zedek Medical Center
Jason D Roberts, MD MAS principal investigator
McMaster University
Wayne Chen, PhD principal investigator
University of Calgary
20 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pacing in people with Calcium Release Deficiency Syndrome (CRDS), run by Population Health Research Institute at 20 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Canada, United States, Belgium, Denmark, France and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jason Roberts, MD MAS (905-297-3479 ext. 40632, jason.roberts@phri.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ΔT-wave amplitude value (time frame: At time of pacing maneuver). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06188689, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.