- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02372292
Value of Renal Vascular Doppler Sonography in Management of Decompensated Heart Failure
June 22, 2015 updated by: Özgür Ulaş Özcan, Ankara University
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Ankara, Turkey, 06230
- Ankara University School Of Medicine, Department of Cardiology
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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
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Decompensated heart failure
- Elevated serum creatinine levels on admission
Exclusion Criteria:
- 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
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
- Primary Purpose: DIAGNOSTIC
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Group 1
Patients with type 1 cardiorenal syndrome who had improvement of renal functions along with diuretic therapy.
Intravenous furosemide treatment.
|
Decongestant therapy for decompensated heart failure which may be administrated as intravenous bolus or infusion
Other Names:
|
Active Comparator: Group 2
Patients with type 1 cardiorenal syndrome who did not have improvement of renal functions along with diuretic therapy.
Intravenous furosemide treatment.
|
Decongestant therapy for decompensated heart failure which may be administrated as intravenous bolus or infusion
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Alterations in the renal arterial resistivity index
Time Frame: during hospitalization, an expected average of 4 weeks.
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Participants will be followed for the duration of hospital stay, an expected average of 4 weeks.
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during hospitalization, an expected average of 4 weeks.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Alterations in the renal venous impedance 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.
|
during hospitalization, an expected average of 4 weeks.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
February 1, 2013
Primary Completion (Actual)
June 1, 2015
Study Completion (Actual)
June 1, 2015
Study Registration Dates
First Submitted
February 13, 2015
First Submitted That Met QC Criteria
February 25, 2015
First Posted (Estimate)
February 26, 2015
Study Record Updates
Last Update Posted (Estimate)
June 23, 2015
Last Update Submitted That Met QC Criteria
June 22, 2015
Last Verified
June 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Heart Diseases
- Cardiovascular Diseases
- Kidney Diseases
- Urologic Diseases
- Renal Insufficiency
- Heart Failure
- Cardio-Renal Syndrome
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Natriuretic Agents
- Membrane Transport Modulators
- Diuretics
- Sodium Potassium Chloride Symporter Inhibitors
- Furosemide
Other Study ID Numbers
- Ankararenal
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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