The Role of CVP and EF in Patients With Cardio-renal Syndromes

Completed

• Conditions: Heart Failure

• Registration Number: NCT02792387
• Lead Sponsor: Tbilisi State University

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).

Study Timeline

• Study Start: 2015-09
• Primary Completion: 2016-05
• Study First Submitted: 2016-05-16
• Study First Submitted QC: 2016-06-02
• Study First Posted: 2016-06-07
• Study Completion: 2017-01
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-10
• Last Update Posted: 2017-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
renal impairment (defined as a Glomerular Filtration Rate less than 60 mL/min per 1.73 m2)	through study completion, an average of 1 year	Estimated Glomerular Filtration Rate has been assessed with the Modification of Diet in Renal Disease formula