Cardiorenal SyndromeNCT02372292
Value of Renal Vascular Doppler Sonography in Management of Decompensated Heart Failure
A study testing intravenous furosemide in people with Cardiorenal Syndrome, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
Although the traditional determinant of renal dysfunction in heart failure was suggested as decreased cardiac output and renal hypo perfusion, recent studies have demonstrated the association of persistent systemic venous congestion and kidney dysfunction. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardiorenal Syndrome
- What is being tested?
- intravenous furosemide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Feb 2013to Jun 2015
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Decompensated heart failure
- Elevated serum creatinine levels on admission
Who cannot join
- Atrial fibrillation
- Obstructive uropathy
- Patients with ascites
- Patients who exposed the potential nephrotoxic drugs in the previous week (metformin, antibiotics, chemotherapeutics, iodinated contrast agents and non-steroidal anti-inflammatory agents)
- Patients who needed positive inotropic agents
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara University School Of Medicine, Department of Cardiology
Ankara, 06230
About this study
Although the traditional determinant of renal dysfunction in heart failure was suggested as decreased cardiac output and renal hypo perfusion, recent studies have demonstrated the association of persistent systemic venous congestion and kidney dysfunction. Relief of the congestion has demonstrated to improve renal functions in decompensated heart failure. The current trial was set up to investigate the changes of renal venous impedance and renal arteriolar resistivity indices with diuretic therapy, in patients with congestive renal failure. The investigators asked whether measurement of renal venous impedance index or renal arteriolar resistivity index can guide the practice of diuretic therapy.
- Conditions
- Cardiorenal Syndrome
- Being tested
- intravenous furosemide
- Keywords
- cardiorenal syndrome, decompensated heart failure, renal resistivity index, venous impedance index, kidney failure
- Medical subject headings
- Cardio-Renal Syndrome, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravenous furosemideDrug
Also called Lasix
Decongestant therapy for decompensated heart failure which may be administrated as intravenous bolus or infusion
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Patients with type 1 cardiorenal syndrome who had improvement of renal functions along with diuretic therapy. Intravenous furosemide treatment. Receives: Drug: intravenous furosemide |
| Group 2 | Active comparator | Patients with type 1 cardiorenal syndrome who did not have improvement of renal functions along with diuretic therapy. Intravenous furosemide treatment. Receives: Drug: intravenous furosemide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alterations in the renal arterial resistivity index
Participants will be followed for the duration of hospital stay, an expected average of 4 weeks.
Measured: during hospitalization, an expected average of 4 weeks.
Secondary outcomes (1)
Alterations in the renal venous impedance index
Participants will be followed for the duration of hospital stay, an expected average of 4 weeks.
Measured: during hospitalization, an expected average of 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2015 (estimated)
- Study startFeb 2013
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiorenal SyndromeStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özgür Ulaş Özcan, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02372292
- Sponsor's protocol ID
- Ankararenal
- Status last verified
- Jun 2015
- First submitted
- 13 Feb 2015
- Last updated
- 23 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Value of Renal Vascular Doppler Sonography in Management of Decompensated Heart Failure
- ClinicalTrials.gov ID
- NCT02372292
- Acronym / sponsor ID
- Ankararenal
- Conditions
- Cardiorenal Syndrome
- Keywords
- cardiorenal syndrome, decompensated heart failure, renal resistivity index, venous impedance index, kidney failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 26 Feb 2015 (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.
Although the traditional determinant of renal dysfunction in heart failure was suggested as decreased cardiac output and renal hypo perfusion, recent studies have demonstrated the association of persistent systemic venous congestion and kidney dysfunction. Relief of the congestion has demonstrated to improve renal functions in decompensated heart failure. The current trial was set up to investigate the changes of renal venous impedance and renal arteriolar resistivity indices with diuretic therapy, in patients with congestive renal failure. The investigators asked whether measurement of renal venous impedance index or renal arteriolar resistivity index can guide the practice of diuretic therapy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Drug: intravenous furosemidePatients with type 1 cardiorenal syndrome who had improvement of renal functions along with diuretic therapy. Intravenous furosemide treatment. |
| Group 2 | Active comparator | Drug: intravenous furosemidePatients with type 1 cardiorenal syndrome who did not have improvement of renal functions along with diuretic therapy. Intravenous furosemide treatment. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Decompensated heart failure
- Elevated serum creatinine levels on admission
Key exclusion criteria (5 listed)
- Atrial fibrillation
- Obstructive uropathy
- Patients with ascites
- Patients who exposed the potential nephrotoxic drugs in the previous week (metformin, antibiotics, chemotherapeutics, iodinated contrast agents and non-steroidal anti-inflammatory agents)
- Patients who needed positive inotropic agents
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 |
|---|---|---|
| intravenous furosemideAlso: LasixDecongestant therapy for decompensated heart failure which may be administrated as intravenous bolus or infusion | Drug | Group 1, Group 2 |
Primary outcome
Alterations in the renal arterial resistivity index
Time frame: during hospitalization, an expected average of 4 weeks.
Participants will be followed for the duration of hospital stay, an expected average of 4 weeks.
1 secondary outcome
Alterations in the renal venous impedance index
Time frame: during hospitalization, an expected average of 4 weeks.
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 23 Jun 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intravenous furosemide in people with Cardiorenal Syndrome, run by Ankara University at 1 site in Turkey (Türkiye).
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 2 inclusion and 5 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 23 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Alterations in the renal arterial resistivity index (time frame: during hospitalization, an expected average of 4 weeks.). 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 23 Jun 2015.