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

October 10, 2017 updated by: George Lobzhanidze, Tbilisi State University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

11

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 96 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients who underwent in-patient treatment at medical centers

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tbilisi State University

Investigators

  • Principal Investigator: George Lobzhanidze, MD, Tbilisi State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2015

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

May 16, 2016

First Submitted That Met QC Criteria

June 2, 2016

First Posted (Estimate)

June 7, 2016

Study Record Updates

Last Update Posted (Actual)

October 11, 2017

Last Update Submitted That Met QC Criteria

October 10, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TSU100

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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