A Study Of Orthostatic Hypotension (OH) And Vasovagal Syncope

Overview

About this study

The purpose of this study is to characterize the impact of orthostatic hypotension (OH) and Vasovagal syncope on signals measured using a wearable Holter monitor in the clinic and ambulatory setting and evaluate the relationship of signals measured from the Holter monitor with reported symptom severity of orthostatic intolerance per standard data collection, analysis, and questionnaires.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Willing and capable to provide informed consent

  • Age 18 or above

  • Previously underwent a clinically indicated ARS assessment without complications (including deep breathing, Valsalva maneuver, and tilt table testing).

  • Previously diagnosed with OH, Vasovagal syncope, OR control subjects assessed as normal, based on the ARS assessment. Participant enrollment shall be based on the type of diagnosis.

  • Willing to complete all required study activities.


Exclusion Criteria:

  • Currently enrolled in another clinical trial that might interfere with data collection.

  • Subject is pregnant or planning to become pregnant during the study

  • Active Implantable Medical Device, e.g. cardiac implantable electronic devices, bladder stimulators, diaphragm stimulators, implantable neuro stimulator, implantable active monitoring devices, implantable active drug administration devices, etc

  • Have a prosthetic cardiac valve or previously underwent cardiac valve surgery.

  • Known allergy to materials used in the study (adhesive, ECG electrodes)

  • Diagnosed with syncope due to cardiologic causes.

  • Have had a myocardial infarction in the previous 90 days

  • Have been diagnosed with tachycardia that requires current medical treatment

  • Have any contraindications for exercise testing, tilt table test, Valsalva maneuver test or deep breathing test (judged by the study Principal Investigator)

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 12/29/2025. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Wolfgang Singer, M.D.

Contact us for the latest status

Contact information:

Jennifer Anderson

(507) 284-0336

adc.research@mayo.edu

More information

Publications

Publications are currently not available