Overview

This trial is active, not recruiting.

Condition heart failure
Treatment cvp measurement
Sponsor Tbilisi State University
Start date January 2011
End date October 2016
Trial size 11 participants
Trial identifier NCT02792387, TSU100

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Time perspective retrospective

Primary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 18 years up to 100 years old.

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

Additional Information

Official title The Role of Central Venous Pressure in Patients With Cardio-renal Syndromes Type 1 and Type 2
Principal investigator George Lobzhanidze, MD
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).
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Tbilisi State University.