Clinical trial NCT04175080: Clinical Significance and Diagnosis of Sarcopenia in Cardiac Patients
Official title: Clinical Significance and Diagnosis of Sarcopenia in Patients With Heart Failure With Preserved Ejection Fraction
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Failure With Preserved Ejection Fraction
Hypertension
Sarcopenic Obesity
Lead sponsor: Medical University of Lodz
Sponsor class: OTHER
First posted: 2019-11-22
Enrollment: 190
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Adults in the age 35-70. Patients will be recruited from the patients of Cardiology Outpatient Clinic and Nephrology, Hypertension and Family Medicine Clinic of the University Clinical Hospital WAM - Central Veterans Hospital in Łódź

Brief summary: Obesity sarcopenia, characterized by the coexistence of excess fat and muscle mass reduction, may contribute to the pathophysiology of exercise intolerance in patients with heart failure with preserved ejection fraction (HFpEF). The project will examine the impact of selected circulating miRNAs on processes that may form the pathophysiological basis for HFpEF development and obesity sarcopenia in correlation with biochemical markers, echocardiographic assessment and non-invasive assessment of hemodynamic parameters. In addition, the impact of LDL and HDL on these diseases will be assessed. Determinations of selected adipokines and asymmetric dimethylarginine will also be carried out and their effects on the cardiovascular system will be assessed.


Eligibility criteria: Inclusion Criteria:

* control group: healthy volunteers
* study groups: patients with HFpEF. Patients in which the results of BNP/NT-proBNP did not confirm the diagnosis of HFpEF were classified as hypertensive group.

Exclusion Criteria:

* coronary artery disease
* unstable hypertension
* heart failure class IV NYHA
* condition after percutaneous or surgical revascularization
* pulmonary hypertension in echocardiography
* obstructive or restrictive lung diseases
* congenital heart disease
* arrhythmias (including atrial fibrillation)
* pacemaker or implantable cardioverter defibrillator
* hyperthyroidism or hypothyroidism
* pregnancy or lactation
* hemodynamically significant acquired heart defects
* cardiomyopathies
* GFR \<60 ml/min/1.73 m2
* other medical conditions such as: cancer, significant anemia, diabetes, alcohol and drug abuse, chronic inflammatory diseases and other
* the patient's inability to cooperate and / or give informed consent to participate in the study

Primary outcomes:
measure: The level of biochemical parameters
timeFrame: through study completion, an average of 1 year
measure: Left ventricular systolic and diastolic function
timeFrame: through study completion, an average of 1 year
measure: Arterial stiffness
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Lodz
country: Poland
facility: Department of Hypertension MU of Lodz
Study officials:
affiliation: Department of Hypertension Medical University of Lodz
name: Agata Bielecka-Dąbrowa, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Paduszynska A, Sakowicz A, Banach M, Maciejewski M, Dabrowa M, Bielecka-Dabrowa A. Cardioprotective properties of leptin in patients with excessive body mass. Ir J Med Sci. 2020 Nov;189(4):1259-1265. doi: 10.1007/s11845-020-02211-9. Epub 2020 Mar 20.