CArdioMEtabolic Function and Reserve Capacity in Healthy Adults: The CAMERA Study

Healthy Clinical Trial

— CAMERA  

Official title:

CArdioMEtabolic Function and Reserve Capacity in Healthy Adults: The CAMERA Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06220396
• Other study ID #: 23-007522
• Status: Recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: January 2029

Study information

• Verified date: May 2024
• Source: Mayo Clinic
• Contact: Dr. Borluag's Research Team
• Phone: 507-255-2200
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: January 2029
• Est. primary completion date: January 2029
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Healthy

Intervention

Procedure:
• Right 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
• Magnetic 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.
• Dual 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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulmonary Capillary Wedge Pressure (PCWP) at rest	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.	Baseline
Primary	Pulmonary Capillary Wedge Pressure (PCWP) during exercise	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.	Baseline
Secondary	Trans-cardiac uptake of free fatty acids (FFA) at rest	Trans-cardiac uptake of FFA will be measured using arterial and coronary sinus blood samples collected at rest during cardiac catheterization procedure.	Baseline
Secondary	Trans-cardiac uptake of free fatty acids (FFA) during exercise	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.	Baseline
Secondary	Trans-cardiac uptake of glucose at rest	Trans-cardiac uptake of glucose will be measured using arterial and coronary sinus blood samples collected at rest during the cardiac catheterization procedure.	Baseline
Secondary	Trans-cardiac uptake of glucose during exercise	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.	Baseline
Secondary	Trans-cardiac uptake of ketone bodies at rest	Trans-cardiac uptake of ketone bodies will be measured using arterial and coronary sinus blood samples collected at rest during the cardiac catheterization procedure.	Baseline
Secondary	Trans-cardiac uptake of ketone bodies during exercise	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.	Baseline
Secondary	Left ventricular (LV) global longitudinal strain	LV global longitudinal strain will be assessed by echocardiography conducted during the cardiac catheterization procedure	Baseline
Secondary	Left Atrial (LA) reservoir strain	LA reservoir strain will be assessed by echocardiography conducted during the cardiac catheterization procedure	Baseline
Secondary	Right Ventricular (RV) free wall strain	RV free wall strain will be assessed by echocardiography conducted during the cardiac catheterization procedure	Baseline
Secondary	Myocardial mass	Myocardial mass will be measured by CMR imaging.	Baseline
Secondary	Myocardial volume	Myocardial volume will be measured by CMR imaging.	Baseline
Secondary	Myocardial fat content	Myocardial fat content will be measured by CMR imaging.	Baseline
Secondary	Body fat mass	Body fat mass will be measured using dual X-ray absorptiometry (DEXA)	Baseline
Secondary	Visceral fat content	Visceral fat content will be measured using limited abdominal MRI	Baseline
Secondary	Total blood volume	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).	Baseline
Secondary	Total plasma volume	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).	Baseline
Secondary	Quality of Life (QOL) as assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ)	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.	Baseline
Secondary	Blood glucose level	Blood glucose level will be measured using oral glucose tolerance testing	Baseline
Secondary	Blood insulin level	Blood insulin level will be measured using oral glucose tolerance testing	Baseline
Secondary	Blood free fatty acids (FFA) level	Blood FFA level will be measured using oral glucose tolerance testing	Baseline