NCT02372292

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

February 13, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 26, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

June 23, 2015

Status Verified

June 1, 2015

Enrollment Period

2.3 years

First QC Date

February 13, 2015

Last Update Submit

June 22, 2015

Conditions

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • Alterations in the renal arterial resistivity index

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

    during hospitalization, an expected average of 4 weeks.

Secondary Outcomes (1)

  • Alterations in the renal venous impedance index

    during hospitalization, an expected average of 4 weeks.

Study Arms (2)

Group 1

ACTIVE COMPARATOR

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

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.

Drug: intravenous furosemide

Interventions

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

Also known as: Lasix
Group 1Group 2

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Decompensated heart failure
  • Elevated serum creatinine levels on admission

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara University School Of Medicine, Department of Cardiology

Ankara, 06230, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cardio-Renal SyndromeRenal Insufficiency

Interventions

Furosemide

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesHeart FailureHeart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

SulfanilamidesSulfonamidesAmidesOrganic ChemicalsAniline CompoundsAminesSulfonesSulfur Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 13, 2015

First Posted

February 26, 2015

Study Start

February 1, 2013

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

June 23, 2015

Record last verified: 2015-06

Locations