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Clinical Trials/NCT02792387
NCT02792387
Completed
Not Applicable

Some Characteristics of Interaction Between Heart and Kidneys in Cardio-Renal Syndrome Type 1 and Type 2

Tbilisi State University0 sites11 target enrollmentSeptember 2015
ConditionsHeart Failure

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart Failure
Sponsor
Tbilisi State University
Enrollment
11
Primary Endpoint
renal impairment (defined as a Glomerular Filtration Rate less than 60 mL/min per 1.73 m2)
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

The aim of the study is to explore association between increased central venous pressure, Ejection Fraction and renal dysfunction (eGFR) in patients with Cardio-Renal Syndromes type 1 and 2. The pilot study was set to provide the expected correlation coefficient for a sample size determination of the subsequent study.

Detailed Description

OBJECTIVES The aim of the study is to explore association between increased central venous pressure (CVP), Ejection Fraction (EF) and renal dysfunction (eGFR) in patients with Cardio-Renal Syndromes type 1 and 2. BACKGROUND The pathophysiology of impaired renal function in cardiovascular disease is multifactorial. Recent investigations suggest that management of patients based on low-flow theory does not lead to improved outcomes. Relative importance of right heart dysfunction (manifested as increased CVP) has not been evaluated . Precise understanding of bidirectional pathways by which the heart and kidneys influence each other is necessary to define optimal treatment strategies specific to the subtypes, as therapies directed towards one organ system may have beneficial or unfavorable effects on the other. METHODS The study is of non-experimental (observational) type, based on retrospective chart review. The patients' personal identifiers are concealed and an anonymized datasets used (unique code given to each patient, which is kept secure under the control of hospital staff).

Registry
clinicaltrials.gov
Start Date
September 2015
End Date
January 2017
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Tbilisi State University
Responsible Party
Principal Investigator
Principal Investigator

George Lobzhanidze

MD

Tbilisi State University

Eligibility Criteria

Inclusion Criteria

  • HF (NYHA class I - IV, with preserved and reduced EF) and reduced GFR (Cardio-Renal Syndromes 1 and 2)

Exclusion Criteria

  • Independent risk factors for renal impairment (e.g. diabetes, sepsis)
  • Primary nephropathy or secondary nephropathy due to diseases other than HF

Outcomes

Primary Outcomes

renal impairment (defined as a Glomerular Filtration Rate less than 60 mL/min per 1.73 m2)

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

Estimated Glomerular Filtration Rate has been assessed with the Modification of Diet in Renal Disease formula

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