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NCT04175080 Clinical Trial

Clinical Significance and Diagnosis of Sarcopenia in Cardiac Patients

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04175080
Other study ID # RNN/80/17/KE
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date March 1, 2017
Est. completion date November 2019

Study information
Verified date November 2019
Source Medical Universtity of Lodz
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 190
Est. completion date November 2019
Est. primary completion date August 31, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 35 Years to 70 Years
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
Poland Department of Hypertension MU of Lodz Lodz

Sponsors (1)
Lead Sponsor Collaborator
Medical Universtity of Lodz

Country where clinical trial is conducted

Poland, 

Outcome
Type Measure Description Time frame Safety issue
Primary The level of biochemical parameters through study completion, an average of 1 year
Primary Left ventricular systolic and diastolic function through study completion, an average of 1 year
Primary Arterial stiffness through study completion, an average of 1 year
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