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

Not Applicable

Recruiting

• Conditions: Healthy
• Interventions: Procedure: Right Heart Catheterization with Hemodynamics and Limited Echocardiogram; Procedure: Magnetic Resonance Imaging (MRI); Procedure: Dual X-ray absorptiometry (DEXA) scan

• Registration Number: NCT06220396
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-28
• Study First Submitted QC: 2024-01-12
• Study First Posted: 2024-01-23
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-08
• Last Update Posted: 2025-01-10
• Study Start: 2025-10-01
• Primary Completion: 2029-01
• Study Completion: 2029-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Healthy Volunteers	Dual X-ray absorptiometry (DEXA) scan	Healthy volunteers with no history of Heart Failure (HF) will undergo a Right Heart Catheterization with Hemodynamics and Limited Echocardiogram, MRI, and DEXA scan.
Healthy Volunteers	Magnetic Resonance Imaging (MRI)	Healthy volunteers with no history of Heart Failure (HF) will undergo a Right Heart Catheterization with Hemodynamics and Limited Echocardiogram, MRI, and DEXA scan.
Healthy Volunteers	Right Heart Catheterization with Hemodynamics and Limited Echocardiogram	Healthy volunteers with no history of Heart Failure (HF) will undergo a Right Heart Catheterization with Hemodynamics and Limited Echocardiogram, MRI, and DEXA scan.

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

Name	Time	Method
Myocardial fat content	Baseline	Myocardial fat content will be measured by CMR imaging.
Visceral fat content	Baseline	Visceral fat content will be measured using limited abdominal MRI
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).
Blood glucose level	Baseline	Blood glucose level will be measured using oral glucose tolerance testing
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 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 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.
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 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 Atrial (LA) reservoir strain	Baseline	LA reservoir 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.
Blood insulin level	Baseline	Blood insulin 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
Left ventricular (LV) global longitudinal strain	Baseline	LV global longitudinal 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
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.
Body fat mass	Baseline	Body fat mass will be measured using dual X-ray absorptiometry (DEXA)
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).

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States