NCT06976502

Brief Summary

The purpose of the Health eHeart BioBank is to collect and store specimen (e.g. blood, DNA, tissue) for future studies at the University of California, San Francisco (UCSF) that will help determine changes and identify molecular and genetic markers in the human body that might help increase our knowledge of heart disease and guide development of new diagnostic tools and treatments that may help rapidly detect heart disease and prevent and/or treat heart disease.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500,000

participants targeted

Target at P75+ for all trials

Timeline
117mo left

Started Apr 2025

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress10%
Apr 2025Dec 2035

Study Start

First participant enrolled

April 1, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 8, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 16, 2025

Completed
10.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2035

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2035

Last Updated

June 6, 2025

Status Verified

June 1, 2025

Enrollment Period

10.7 years

First QC Date

May 8, 2025

Last Update Submit

June 5, 2025

Conditions

Keywords

Heart DiseaseCardiovascular DiseaseCardiology

Outcome Measures

Primary Outcomes (1)

  • Establish and Maintain a Centralized Biorepository

    Establish and maintain a centralized biorepository to collect and store a variety of biospecimen samples and clinical data. This would allow for the samples and clinical data to be used to test hypotheses regarding the molecular and genetic basis of diagnosis and treatment of cardiovascular diseases.

    Up to 10 years

Study Arms (3)

Participants with a History of Cardiovascular Disease

Procedure: Blood DrawProcedure: Tissue CollectionProcedure: DNA CollectionOther: Medical Chart Review

Participants with a Family History of Cardiovascular Disease

Procedure: Blood DrawProcedure: Tissue CollectionProcedure: DNA CollectionOther: Medical Chart Review

Healthy Controls

Procedure: Blood DrawProcedure: Tissue CollectionProcedure: DNA CollectionOther: Medical Chart Review

Interventions

Blood DrawPROCEDURE

Participants will be asked to contribute approximately 36 mL of blood using standard procedures and obtained at the time of a clinically ordered routine blood draw or a study ordered blood draw. Participants may be asked to contribute additional blood samples over the course of their participation in the study.

Healthy ControlsParticipants with a Family History of Cardiovascular DiseaseParticipants with a History of Cardiovascular Disease

If the participant is undergoing a clinically ordered procedure (e.g. heart surgery/biopsy/transplant), then they will be asked to contribute tissue to the study before any tissue is collected during the procedure. Most samples collected by the HeH BioBank will be tissue that would be normally discarded after the procedure.

Healthy ControlsParticipants with a Family History of Cardiovascular DiseaseParticipants with a History of Cardiovascular Disease

Participants will be asked to contribute their DNA for Whole Genome Sequencing (WGS) to help identify genetic markers of heart disease. DNA will be obtained at the time of the blood draw or obtained through DNA collection kits administered to participants who are unable or unwilling to undergo a blood draw.

Healthy ControlsParticipants with a Family History of Cardiovascular DiseaseParticipants with a History of Cardiovascular Disease

Demographic, clinical, and pathologic information will be extracted from the participant's medical record.

Also known as: Medical Record Review
Healthy ControlsParticipants with a Family History of Cardiovascular DiseaseParticipants with a History of Cardiovascular Disease

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Study population are patients of the University of California, San Francisco and their relatives.

You may qualify if:

  • Age ≥ 18 years or older.
  • And at least one of the following:
  • Established patient seen at UCSF and/or is a current participant in a clinical study that utilizes the HeH BioBank for biospecimen collection.
  • Family member of a patient with cardiovascular disease.
  • Patient with no cardiovascular disease.

You may not qualify if:

  • Unwilling to consent to biospecimen collection through the HeH BioBank.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94158, United States

Location

Related Publications (9)

  • Rahmutula D, Marcus GM, Wilson EE, Ding CH, Xiao Y, Paquet AC, Barbeau R, Barczak AJ, Erle DJ, Olgin JE. Molecular basis of selective atrial fibrosis due to overexpression of transforming growth factor-beta1. Cardiovasc Res. 2013 Sep 1;99(4):769-79. doi: 10.1093/cvr/cvt074. Epub 2013 Apr 23.

    PMID: 23612580BACKGROUND
  • Tseng ZH, Olgin JE, Vittinghoff E, Ursell PC, Kim AS, Sporer K, Yeh C, Colburn B, Clark NM, Khan R, Hart AP, Moffatt E. Prospective Countywide Surveillance and Autopsy Characterization of Sudden Cardiac Death: POST SCD Study. Circulation. 2018 Jun 19;137(25):2689-2700. doi: 10.1161/CIRCULATIONAHA.117.033427.

    PMID: 29915095BACKGROUND
  • Aouizerat BE, Vittinghoff E, Musone SL, Pawlikowska L, Kwok PY, Olgin JE, Tseng ZH. GWAS for discovery and replication of genetic loci associated with sudden cardiac arrest in patients with coronary artery disease. BMC Cardiovasc Disord. 2011 Jun 10;11:29. doi: 10.1186/1471-2261-11-29.

    PMID: 21658281BACKGROUND
  • Roberts JD, Hsu JC, Aouizerat BE, Pullinger CR, Malloy MJ, Kane JP, Olgin JE, Marcus GM. Impact of a 4q25 genetic variant in atrial flutter and on the risk of atrial fibrillation after cavotricuspid isthmus ablation. J Cardiovasc Electrophysiol. 2014 Mar;25(3):271-277. doi: 10.1111/jce.12317. Epub 2013 Dec 13.

    PMID: 24237655BACKGROUND
  • Roberts JD, Dewland TA, Glidden DV, Hoffmann TJ, Arking DE, Chen LY, Psaty BM, Olgin JE, Alonso A, Heckbert SR, Marcus GM. Impact of genetic variants on the upstream efficacy of renin-angiotensin system inhibitors for the prevention of atrial fibrillation. Am Heart J. 2016 May;175:9-17. doi: 10.1016/j.ahj.2016.02.002. Epub 2016 Feb 13.

    PMID: 27179719BACKGROUND
  • Roberts JD, Dewland TA, Longoria J, Fitzpatrick AL, Ziv E, Hu D, Lin J, Glidden DV, Psaty BM, Burchard EG, Blackburn EH, Olgin JE, Heckbert SR, Marcus GM. Telomere length and the risk of atrial fibrillation: insights into the role of biological versus chronological aging. Circ Arrhythm Electrophysiol. 2014 Dec;7(6):1026-32. doi: 10.1161/CIRCEP.114.001781. Epub 2014 Nov 8.

    PMID: 25381796BACKGROUND
  • Marcus GM, Smith LM, Glidden DV, Wilson E, McCabe JM, Whiteman D, Tseng ZH, Badhwar N, Lee BK, Lee RJ, Scheinman MM, Olgin JE. Markers of inflammation before and after curative ablation of atrial flutter. Heart Rhythm. 2008 Feb;5(2):215-21. doi: 10.1016/j.hrthm.2007.10.007. Epub 2007 Oct 7.

    PMID: 18242542BACKGROUND
  • Roberts JD, Longoria J, Poon A, Gollob MH, Dewland TA, Kwok PY, Olgin JE, Deo RC, Marcus GM. Targeted deep sequencing reveals no definitive evidence for somatic mosaicism in atrial fibrillation. Circ Cardiovasc Genet. 2015 Feb;8(1):50-7. doi: 10.1161/CIRCGENETICS.114.000650. Epub 2014 Nov 18.

    PMID: 25406240BACKGROUND
  • Marcus GM, Rosenthal DG, Nah G, Vittinghoff E, Fang C, Ogomori K, Joyce S, Yilmaz D, Yang V, Kessedjian T, Wilson E, Yang M, Chang K, Wall G, Olgin JE. Acute Effects of Coffee Consumption on Health among Ambulatory Adults. N Engl J Med. 2023 Mar 23;388(12):1092-1100. doi: 10.1056/NEJMoa2204737.

    PMID: 36947466BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples with be collected with the option of DNA, heart tissue, and other samples may be collected.

MeSH Terms

Conditions

Heart DiseasesVascular DiseasesCardiovascular Diseases

Interventions

Blood Specimen CollectionTissue Banks

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesBiological Specimen BanksHealth FacilitiesHealth Care Facilities Workforce and Services

Study Officials

  • Jeffrey E Olgin, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR
  • Gregory Marcus, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR
  • Vasanth Vedantham, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR
  • Connor G O'Brien, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR
  • James P Pirruccello, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
20 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2025

First Posted

May 16, 2025

Study Start

April 1, 2025

Primary Completion (Estimated)

December 1, 2035

Study Completion (Estimated)

December 1, 2035

Last Updated

June 6, 2025

Record last verified: 2025-06

Locations