Anti-Angiotensin-Receptor 1 (ATR1)-, Anti-Endothelin-Receptor A (ETRA)-Antibodies and T Cells in Cardiomyopathy
T-CARD
The Role of Functional Active Anti-Angiotensin-Receptor 1 (ATR1)- and Anti-Endothelin-Receptor A (ETRA)-Antibodies and Autoreactive T Cells in Cardiomyopathy
1 other identifier
observational
80
1 country
1
Brief Summary
The study aims 1) to determine autoantibody titers against the AGTR1 receptor and against the ETA receptor, 2) to characterize cytokine expression profiles of heart-specific activated T cells in patients with systolic heart failure. Auto-antibody titers and specific cytokine expression profiles in heart-specific activated T cells will then be correlated with heart failure progression and outcome.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2014
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2014
CompletedFirst Submitted
Initial submission to the registry
December 7, 2014
CompletedFirst Posted
Study publicly available on registry
December 18, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedJuly 15, 2021
July 1, 2021
5 years
December 7, 2014
July 13, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Combined endpoint of heart failure hospitalization, cardiovascular event, transplantation and death
cardiovascular event = cerebral ischemia/infarction, myocardial infarction/ACS, revascularization, critical limb/organ ischemia, vascular dissection, thromboembolism
1 year
Secondary Outcomes (5)
Ejection fraction (EF)
1 Year
Maximal Exercise Oxygen Consumption (VO2 max)
6 month, 1 year
NYHA class (NYHA)
6 month, 1 year
Arrhythmia burden (AB)
1 year
CRT Responder (CRT-Resp)
1 year
Study Arms (4)
heart failure, no CAD, QRS < 150ms
no CAD, QRS \< 150ms
heart failure, CAD QRS < 150ms
CAD, QRS \< 150ms
heart failure, CAD > 150ms
CAD, QRS \> 150ms
heart failure, no CAD, > 150ms
no CAD, QRS \> 150ms
Eligibility Criteria
Heart failure patients, EF \< 35%, either CAD (re-vascularized) or other type of heart failure
You may qualify if:
- Aged 18 to 85
- Left ventricular ejection fraction \<35%
- Established medical heart failure therapy
- Informed consent
You may not qualify if:
- mental or physical disability precluding informed consent or compliance with the protocol.
- Active auto-immune disease (rheumatoid arthritis, systemic sclerosis, sytemic lupus erythematodes, polymyositis or others)
- Active infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
GZO Regional Health Center
Wetzikon, CH-8620, Switzerland
Biospecimen
T cells
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Urs Eriksson, MD
GZO Regional Health Center and University of Zurich
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Cardiology and Medicine, Chief Medical Office
Study Record Dates
First Submitted
December 7, 2014
First Posted
December 18, 2014
Study Start
December 1, 2014
Primary Completion
December 1, 2019
Study Completion
December 1, 2020
Last Updated
July 15, 2021
Record last verified: 2021-07