Heart FailureRoCVPinCRSsNCT02792387
The Role of CVP and EF in Patients With Cardio-renal Syndromes
An observational study of Heart Failure, run by Tbilisi State University.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- CVP measurement
- How many people
- 11 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Jan 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients who underwent in-patient treatment at medical centers
Who may be able to join
- HF (NYHA class I - IV, with preserved and reduced EF) and reduced GFR (Cardio-Renal Syndromes 1 and 2)
Who cannot join
- Independent risk factors for renal impairment (e.g. diabetes, sepsis)
- Primary nephropathy or secondary nephropathy due to diseases other than HF
About this study
Official title: 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.
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).
- Conditions
- Heart Failure
- Being tested
- CVP measurement
- Keywords
- cardio-renal syndrome, right heart dysfunction, central venous pressure, eGFR, low-flow theory
- Medical subject headings
- Heart Failure, Cardio-Renal Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CVP measurementOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2016 (estimated)
- Study startSep 2015
- Primary completionMay 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tbilisi State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, George Lobzhanidze, Tbilisi State University
- Investigators
- George Lobzhanidze, MD, Principal investigator, Tbilisi State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02792387
- Sponsor's protocol ID
- TSU100
- Acronym
- RoCVPinCRSs
- Status last verified
- Oct 2017
- First submitted
- 16 May 2016
- Last updated
- 11 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Some Characteristics of Interaction Between Heart and Kidneys in Cardio-Renal Syndrome Type 1 and Type 2
- ClinicalTrials.gov ID
- NCT02792387
- Acronym / sponsor ID
- RoCVPinCRSs / TSU100
- Conditions
- Heart Failure
- Keywords
- cardio-renal syndrome, right heart dysfunction, central venous pressure, eGFR, low-flow theory
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Tbilisi State UniversityUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- May 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 7 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients who underwent in-patient treatment at medical centers
Key inclusion criteria (1 listed)
- HF (NYHA class I - IV, with preserved and reduced EF) and reduced GFR (Cardio-Renal Syndromes 1 and 2)
Key exclusion criteria (2 listed)
- Independent risk factors for renal impairment (e.g. diabetes, sepsis)
- Primary nephropathy or secondary nephropathy due to diseases other than HF
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CVP measurementCVP 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. | Other | – |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George Lobzhanidze, MD principal investigator
Tbilisi State University
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Tbilisi State University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2017.