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Value of Renal Vascular Doppler Sonography in Management of Decompensated Heart Failure

Primary Purpose

Cardiorenal Syndrome

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

intravenous furosemide

About this trial

This is an interventional diagnostic trial for Cardiorenal Syndrome focused on measuring cardiorenal syndrome, decompensated heart failure, renal resistivity index, venous impedance index, kidney failure

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Ankara University School Of Medicine, Department of Cardiology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Group 1

Group 2

Arm Description

Patients with type 1 cardiorenal syndrome who had improvement of renal functions along with diuretic therapy. Intravenous furosemide treatment.

Patients with type 1 cardiorenal syndrome who did not have improvement of renal functions along with diuretic therapy. Intravenous furosemide treatment.

Outcomes

Primary Outcome Measures

Alterations in the renal arterial resistivity index

Participants will be followed for the duration of hospital stay, an expected average of 4 weeks.

Secondary Outcome Measures

Alterations in the renal venous impedance index

Participants will be followed for the duration of hospital stay, an expected average of 4 weeks.

Full Information

NCT ID

NCT02372292

First Posted

February 13, 2015

Last Updated

June 22, 2015

Sponsor

Ankara University

1. Study Identification

Unique Protocol Identification Number

NCT02372292

Brief Title

Value of Renal Vascular Doppler Sonography in Management of Decompensated Heart Failure

Official Title

Value of Renal Vascular Doppler Sonography in Management of Decompensated Heart Failure

Study Type

Interventional

2. Study Status

Record Verification Date

June 2015

Overall Recruitment Status

Completed

Study Start Date

February 2013 (undefined)

Primary Completion Date

June 2015 (Actual)

Study Completion Date

June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ankara University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cardiorenal Syndrome

Keywords

cardiorenal syndrome, decompensated heart failure, renal resistivity index, venous impedance index, kidney failure

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Non-Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1

Arm Type

Active Comparator

Arm Description

Patients with type 1 cardiorenal syndrome who had improvement of renal functions along with diuretic therapy. Intravenous furosemide treatment.

Arm Title

Group 2

Arm Type

Active Comparator

Arm Description

Patients with type 1 cardiorenal syndrome who did not have improvement of renal functions along with diuretic therapy. Intravenous furosemide treatment.

Intervention Type

Drug

Intervention Name(s)

intravenous furosemide

Other Intervention Name(s)

Lasix

Intervention Description

Decongestant therapy for decompensated heart failure which may be administrated as intravenous bolus or infusion

Primary Outcome Measure Information:

Title

Alterations in the renal arterial resistivity index

Description

Participants will be followed for the duration of hospital stay, an expected average of 4 weeks.

Time Frame

during hospitalization, an expected average of 4 weeks.

Secondary Outcome Measure Information:

Title

Alterations in the renal venous impedance index

Description

Participants will be followed for the duration of hospital stay, an expected average of 4 weeks.

Time Frame

during hospitalization, an expected average of 4 weeks.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Ankara University School Of Medicine, Department of Cardiology

City

Ankara

ZIP/Postal Code

06230

Country

Turkey

12. IPD Sharing Statement

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Value of Renal Vascular Doppler Sonography in Management of Decompensated Heart Failure

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