Clinical Significance and Diagnosis of Sarcopenia in Cardiac Patients

NCT ID: NCT04175080

Last Updated: 2019-11-22

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 190 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-03-01
• Study Completion Date: 2019-11-30

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.

Conditions

Heart Failure With Preserved Ejection Fraction; Hypertension; Sarcopenic Obesity

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Control

No interventions assigned to this group

HFpEF group

No interventions assigned to this group

Hypertensive group

Patients in which the results of BNP/NT-proBNP did not confirm the diagnosis of HFpEF were classified as hypertensive group.

No interventions assigned to this group

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medical University of Lodz

OTHER

Sponsor Role: lead

Responsible Party

Agata Bielecka-Dabrowa, MD, PhD, Department of Hypertension

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Agata Bielecka-Dąbrowa, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Hypertension Medical University of Lodz

Locations

Department of Hypertension MU of Lodz

Lodz, , Poland

Countries

Poland

References

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.

Reference Type: DERIVED

PMID: 32198598 (View on PubMed)

Other Identifiers

RNN/80/17/KE

Identifier Type: -

Identifier Source: org_study_id