Clinical trial NCT06220396: CArdioMEtabolic Function and Reserve Capacity in Healthy Adults: The CAMERA Study
Official title: CArdioMEtabolic Function and Reserve Capacity in Healthy Adults: The CAMERA Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-01-23
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Pulmonary Capillary Wedge Pressure (PCWP) at rest
timeFrame: Baseline
measure: Pulmonary Capillary Wedge Pressure (PCWP) during exercise
timeFrame: Baseline
Secondary outcomes:
measure: Trans-cardiac uptake of free fatty acids (FFA) at rest
timeFrame: Baseline
measure: Trans-cardiac uptake of free fatty acids (FFA) during exercise
timeFrame: Baseline
measure: Trans-cardiac uptake of glucose at rest
timeFrame: Baseline
measure: Trans-cardiac uptake of glucose during exercise
timeFrame: Baseline
measure: Trans-cardiac uptake of ketone bodies at rest
timeFrame: Baseline
measure: Trans-cardiac uptake of ketone bodies during exercise
timeFrame: Baseline
measure: Left ventricular (LV) global longitudinal strain
timeFrame: Baseline
measure: Left Atrial (LA) reservoir strain
timeFrame: Baseline
measure: Right Ventricular (RV) free wall strain
timeFrame: Baseline
measure: Myocardial mass
timeFrame: Baseline
measure: Myocardial volume
timeFrame: Baseline
measure: Myocardial fat content
timeFrame: Baseline
measure: Body fat mass
timeFrame: Baseline
measure: Visceral fat content
timeFrame: Baseline
measure: Total blood volume
timeFrame: Baseline
measure: Total plasma volume
timeFrame: Baseline
measure: Quality of Life (QOL) as assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ)
timeFrame: Baseline
measure: Blood glucose level
timeFrame: Baseline
measure: Blood insulin level
timeFrame: Baseline
measure: Blood free fatty acids (FFA) level
timeFrame: Baseline
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Barry Borlaug, MD
role: PRINCIPAL_INVESTIGATOR
References: