Healthy
Conditions
Brief summary
The purpose of this study is to evaluate pulmonary capillary wedge pressure (PCWP) and other hemodynamic measurements at rest and during exercise in healthy volunteers across the age spectrum.
Interventions
PROCEDURERight Heart Catheterization with Hemodynamics and Limited Echocardiogram
Right Heart Catheterization (RHC) with Hemodynamics and Limited Echocardiogram is an invasive procedure that involves insertion of a catheter through a blood vessel in the neck, groin, or arm to the right side of the heart. Hemodynamic measurements such as the blood pressure inside the veins, heart, and arteries as well as measurements of blood flow and how much oxygen is in the blood will be completed during the catheterization procedure. It is a way to see how well the heart is working during your procedure. During the RHC procedure a limited echocardiogram, using ultrasound waves, will be collected to evaluate the structure and function of the heart. All measurements will be conducted at rest and during exercise using a supine cycle ergometer
PROCEDUREMagnetic Resonance Imaging (MRI)
MRI is a medical imaging technique that uses a magnetic field and computer-generated radio waves to create detailed images of the organs and tissues in your body. CMR Imaging will assess myocardial structure, function, and fat content. An additional limited MRI sequence of the the abdomen and one sequence in the thigh will be used to evaluate for visceral adipose tissue (VAT) as a measurement of body composition.
PROCEDUREDual X-ray absorptiometry (DEXA) scan
A DEXA scan measures the amount of fat in the body using an x-ray that measures bone, calcium and fat.
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Apparently healthy volunteers are eligible to participate in this study if they are free of symptoms of exertional breathlessness or fatigue and any diagnosis of heart failure. * Patients will also be required to have left ventricular ejection fraction (EF) ≥ 50%. * Patients discovered to reduced EF or abnormal resting hemodynamics or other pathologic findings previously undiscovered will be considered screen failures and can be replaced by others to reach the goal enrollment. * Informed consent were obtained. * No history of heart failure. * Willing and able to undergo invasive hemodynamic exercise testing, MRI, and other study assessments.
Exclusion criteria
* Clinically significant symptoms of exertional dyspnea or fatigue in daily life in the opinion of the investigators. * Any diagnosis of heart failure * Symptomatic coronary artery disease (e.g., patients with chronic angina) * Symptomatic valvular heart disease * Pulmonary hypertension * Cardiomyopathies * High output heart failure * Pericardial disease * Clinically significant chronic lung disease in the opinion of the investigators * Anemia (hemoglobin \<12 gm/dL in women and \<13 gm/dL in men) * Estimated glomerular filtration rate ≤30mL/min * Pregnant women * Any other disorders or problems that would interfere with the ability to participate safely in the study (e.g. psychiatric disorder or substance abuse)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pulmonary Capillary Wedge Pressure (PCWP) during exercise | Baseline | Pulmonary capillary wedge pressure is a measure of cardiac filling pressure, measured using a high-fidelity micromanometer advanced through the lumen of a fluid-filled catheter during exercise. |
| Pulmonary Capillary Wedge Pressure (PCWP) at rest | Baseline | Pulmonary capillary wedge pressure is a measure of cardiac filling pressure, measured using a high-fidelity micromanometer advanced through the lumen of a fluid-filled catheter at rest. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Trans-cardiac uptake of free fatty acids (FFA) during exercise | Baseline | Trans-cardiac uptake of FFA will be measured using arterial and coronary sinus blood samples collected during the exercise portion of the cardiac catheterization procedure. |
| Trans-cardiac uptake of glucose at rest | Baseline | Trans-cardiac uptake of glucose will be measured using arterial and coronary sinus blood samples collected at rest during the cardiac catheterization procedure. |
| Trans-cardiac uptake of glucose during exercise | Baseline | Trans-cardiac uptake of glucose will be measured using arterial and coronary sinus blood samples collected during the exercise portion of the cardiac catheterization procedure. |
| Trans-cardiac uptake of ketone bodies at rest | Baseline | Trans-cardiac uptake of ketone bodies will be measured using arterial and coronary sinus blood samples collected at rest during the cardiac catheterization procedure. |
| Trans-cardiac uptake of ketone bodies during exercise | Baseline | Trans-cardiac uptake of ketone bodies will be measured using arterial and coronary sinus blood samples collected during the exercise portion of the cardiac catheterization procedure. |
| Left ventricular (LV) global longitudinal strain | Baseline | LV global longitudinal strain will be assessed by echocardiography conducted during the cardiac catheterization procedure |
| Left Atrial (LA) reservoir strain | Baseline | LA reservoir strain will be assessed by echocardiography conducted during the cardiac catheterization procedure |
| Right Ventricular (RV) free wall strain | Baseline | RV free wall strain will be assessed by echocardiography conducted during the cardiac catheterization procedure |
| Myocardial mass | Baseline | Myocardial mass will be measured by CMR imaging. |
| Myocardial volume | Baseline | Myocardial volume will be measured by CMR imaging. |
| Myocardial fat content | Baseline | Myocardial fat content will be measured by CMR imaging. |
| Body fat mass | Baseline | Body fat mass will be measured using dual X-ray absorptiometry (DEXA) |
| Visceral fat content | Baseline | Visceral fat content will be measured using limited abdominal MRI |
| Total blood volume | Baseline | Total blood volume will be assessed by using the radiolabeled iodinated albumin (131I, 5-25 μCu) indicator dilution technique (BVA-100 Blood Volume Analyzer, Daxor Corp, NY). |
| Total plasma volume | Baseline | Total plasma volume will be assessed by using the radiolabeled iodinated albumin (131I, 5-25 μCu) indicator dilution technique (BVA-100 Blood Volume Analyzer, Daxor Corp, NY). |
| Quality of Life (QOL) as assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) | Baseline | KCCQ was a 23-item, self-administered questionnaire that measure the participant's perception of their health status, including their heart failure (HF) symptoms, impact on physical and social function and how their HF impacts the quality of life. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 to 100, with 0 (worst) and 100 (the best possible status), where the higher score reflected better health status. |
| Blood glucose level | Baseline | Blood glucose level will be measured using oral glucose tolerance testing |
| Blood free fatty acids (FFA) level | Baseline | Blood FFA level will be measured using oral glucose tolerance testing |
| Blood insulin level | Baseline | Blood insulin level will be measured using oral glucose tolerance testing |
| Trans-cardiac uptake of free fatty acids (FFA) at rest | Baseline | Trans-cardiac uptake of FFA will be measured using arterial and coronary sinus blood samples collected at rest during cardiac catheterization procedure. |
Countries
United States
Contacts
CONTACTBrendon Urena
CONTACTBarry Borlaug, MD
PRINCIPAL_INVESTIGATORBarry Borlaug, MD
Mayo Clinic
Outcome results
None listed