Clinical Significance and Diagnosis of Sarcopenia in Cardiac Patients

• Conditions: Heart Failure With Preserved Ejection Fraction; Hypertension; Sarcopenic Obesity

• Registration Number: NCT04175080
• Lead Sponsor: Medical University of Lodz

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-01
• Primary Completion: 2019-08-31
• Status Verified: 2019-11
• Study Completion: 2019-11
• Study First Submitted: 2019-11-19
• Study First Submitted QC: 2019-11-20
• Last Update Submitted: 2019-11-20
• Study First Posted: 2019-11-22
• Last Update Posted: 2019-11-22

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 190

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Arterial stiffness	through study completion, an average of 1 year
Left ventricular systolic and diastolic function	through study completion, an average of 1 year
The level of biochemical parameters	through study completion, an average of 1 year

Trial Locations

Locations (1)

Department of Hypertension MU of Lodz; 🇵🇱 Lodz, Poland