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Clinical Trials/NCT04175080
NCT04175080
Unknown
Not Applicable

Clinical Significance and Diagnosis of Sarcopenia in Patients With Heart Failure With Preserved Ejection Fraction

Medical University of Lodz1 site in 1 country190 target enrollmentMarch 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart Failure With Preserved Ejection Fraction
Sponsor
Medical University of Lodz
Enrollment
190
Locations
1
Primary Endpoint
Arterial stiffness
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2017
End Date
November 2019
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

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

Principal Investigator

Medical University of Lodz

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

Outcomes

Primary Outcomes

Arterial stiffness

Time Frame: through study completion, an average of 1 year

Left ventricular systolic and diastolic function

Time Frame: through study completion, an average of 1 year

The level of biochemical parameters

Time Frame: through study completion, an average of 1 year

Study Sites (1)

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