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

Heart Failure Clinical Trial

— RoCVPinCRSs  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02792387
• Other study ID #: TSU100
• Status: Completed
• Phase: N/A
• First received: May 16, 2016
• Last updated: October 10, 2017
• Start date: September 2015
• Est. completion date: January 2017

Study information

• Verified date: October 2017
• Source: Tbilisi State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: January 2017
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardio-Renal Syndrome
• Heart Failure

Intervention

Other:
• CVP measurement
CVP measurements had been performed with an electronic pressure transducer in spontaneously breathing non-ventilated patients. Central vein access was established trough the subclavian or internal jugular veins. Mean CVP was recorded for each patient, measured in mmHg.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tbilisi State University

Outcome

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