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NCT05849025 Clinical Trial

A Study of Invasive Hemodynamic for MACHD Registry

Healthy Clinical Trial

Official title:
Invasive Hemodynamic Control Cohort for The Mayo Clinic Adult Congenital Heart Disease (MACHD) Registry

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05849025
Other study ID # 23-001939
Secondary ID R01HL160761
Status Recruiting
Phase
First received
Last updated
Start date October 16, 2023
Est. completion date October 2026

Study information
Verified date February 2024
Source Mayo Clinic
Contact ACHD Research Program
Phone (507) 293-2565
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This research study is being done to provide comparative data to the Mayo Clinic Adult Congenital Heart Disease Registry.

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date October 2026
Est. primary completion date October 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Capacity to Consent - BMI </= 30 - Systolic BP </= 140mmHg - Diastolic BP </= 90 - eGFR > 30 (within prior 3 months) to confirm kidney function - Able to undergo an MRI Exclusion Criteria: - History of Cardiovascular disease that may affect the results of the testing performed. - Any Current orthopedic limitations - Currently taking any cardiac medication - Pregnancy

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Mayo Clinic Rochester Rochester Minnesota

Sponsors (2)
Lead Sponsor Collaborator
Mayo Clinic National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pulmonary vascular reserve The slope of mean pulmonary artery pressure / cardiac output (mPAP/CO) Baseline
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