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CompletedNCT02792387RoCVPinCRSsUpdated Oct 11, 2017

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

An observational study in Heart Failure, sponsored by Tbilisi State University. Completed. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2017-10-11.

Sponsored by Tbilisi State University · Observational

Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
11
Ages
18 Years to 100 Years
Sex
All
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Study 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.

Read the 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).

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Conditions studied

  • Heart Failure

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Keywords

  • cardio-renal syndrome
  • right heart dysfunction
  • central venous pressure
  • eGFR
  • low-flow theory
03

In context

Cardio-Renal Syndrome

76 studies on the registry are indexed under Cardio-Renal Syndrome; 22 are open to participants now.

This study's enrollment of 11 is below the median of 150 across 26 observational studies indexed under Cardio-Renal Syndrome.

Browse Cardio-Renal Syndrome studies →

Lead sponsor

This is the only study on the registry with Tbilisi State University as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

patients who underwent in-patient treatment at medical centers

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Independent risk factors for renal impairment (e.g. diabetes, sepsis)
  • Primary nephropathy or secondary nephropathy due to diseases other than HF
05

Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
11 participants (actual)
Patient registry
No

Interventions

  • OtherCVP 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.

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What researchers measure

Primary outcomes

  1. 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

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

07

Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 11, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02792387
Lead sponsor
Tbilisi State University
Responsible party
George Lobzhanidze (MD, Tbilisi State University) — Principal investigator
First posted
Jun 7, 2016
Start date
Sep 2015
Primary completion
May 2016
Completion
Jan 2017
Last update
Oct 11, 2017

Study contacts

George Lobzhanidze, MD
principal investigator · Tbilisi State University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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