The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT05773300
Recruitment Status : **RECRUITING NOW**
First Posted : March 17, 2023
Last Update Posted : March 17, 2023
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Alexander C. Egbe, Mayo Clinic
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Brief Summary:
This research study is being done to provide comparative data to the Mayo Clinic Adult Congenital Heart Disease Registry.
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Study Type :
Observational [Patient Registry]
Estimated Enrollment :
75 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Target Follow-Up Duration:
6 Months
Official Title:
Control Population for the Mayo Clinic Adult Congenital Heart Disease Registry
Actual Study Start Date :
January 6, 2022
Estimated Primary Completion Date :
January 2025
Estimated Study Completion Date :
December 2025
Resource links provided by the National Library of Medicine
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Primary Outcome Measures :
Peak Oxygen Uptake [ Time Frame: 6 Months ]
Peak Oxygen Uptake (L/min) : 1.7 ± 0.1
Peak Right Ventricular – Pulmonary Coupling [ Time Frame: 6 Months ]
Peak Right Ventricular – Pulmonary Coupling: (|%|/mmHg): 0.786 ± 0.065
Biospecimen Retention: Â Samples Without DNA2x1ml Whole Blood, 4x1mL plasma
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Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
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Ages Eligible for Study: Â
18 Years to 70 Years  (Adult, Older Adult)
Sexes Eligible for Study: Â
All
Accepts Healthy Volunteers: Â
Yes
Sampling Method: Â
Non-Probability Sample
Subjects will be healthy individuals with no history of cardiovascular disease selected from Mayo Clinic in Rochester, Minnesota.
Inclusion Criteria:
BMI ≤ 30.
No current cardiac medications.
Systolic BP ≤ 140 mmHg.
Diastolic BP ≤ 90 mmHg.
Capacity to consent.
Exclusion Criteria:
To be assessed via EMR screening.
Patient confirmation during screening visit.
Screening tests as applicable.
History of cardiovascular disease. eGFR < 30.
Current orthopedic limitations.
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Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05773300
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Mayo Clinic Minnesota
Rochester, Minnesota, United States, 55905
Contact: Halley Davison   507-293-2565   rstachdresprg@mayo.edu  Â
Mayo Clinic
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
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Principal Investigator:
Alexander Egbe, MBBS, MPH
Mayo Clinic
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Responsible Party:
Alexander C. Egbe, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT05773300 Â Â
Other Study ID Numbers:
21-011938R01HL158517 ( U.S. NIH Grant/Contract )
First Posted:
March 17, 2023 Â Â Key Record Dates
Last Update Posted:
March 17, 2023
Last Verified:
March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
No
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Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
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Heart DiseasesHeart Defects, CongenitalCardiovascular DiseasesCardiovascular AbnormalitiesCongenital Abnormalities
Source: View full study details on ClinicalTrials.gov
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
