Predictive Value of Renal Venous Flow Profiles for Adverse Outcomes in Right Heart Failure

February 16, 2020 updated by: Faeq Husain, University of Giessen
Predictive value of renal venous flow profiles for adverse outcomes in patients with right heart failure

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Persistent congestion with deteriorating renal function is an important cause of adverse outcomes in heart failure. The investigators aimed to characterize new Doppler ultrasonography approaches to evaluate the continuum of renal congestion. Pulmonary hypertension is the most common precursor to right heart failure and thus represents an ideal scenario to study congestion. The second cohort comprises consecutive Cardiology inpatients aged ≥18 years with a new or pre-existing diagnosis of heart failure who are referred to the consultant nephrologist with a history of diuretic-resistant fluid overload and impaired renal function. The investigators choose patients with heart failure to broaden the findings to the most common clinical entity of right ventricular failure.

Study Type

Observational

Enrollment (Actual)

421

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

  • Germany
    • Hessen
      • Giessen, Hessen, Germany, 35392
        • University Clinic Giessen and Marburg - Campus Giessen

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Consecutive Pulmonology inpatients with suspected or pre-diagnosed pulmonary hypertension undergoing right heart catheterization (pulmonary hypertension cohort) and consecutive Cardiology inpatients who are referred to the consultant nephrologist with a history of diuretic-resistant fluid overload and impaired renal function (heart failure cohort).

Description

Pulmonary hypertension cohort:

Exclusion Criteria:

  • CKD stage 5 (KDIGO)
  • pre-existing acute kidney injury (acute kidney injury was defined as an increase in serum creatinine by ≥ 0.3 mg/dl within 48 hours or to ≥ 1.5 times baseline within the prior 7 days, as determined by all available serum creatinine values from hospital and outpatient medical records within the previous 90 days)
  • Non-end stage renal disease patients with extracorporeal or peritoneal ultrafiltration for treatment of diuretic-resistant fluid overload
  • Patients with primary kidney disease (e.g., glomerulonephritis, autosomal dominant polycystic kidney disease, postrenal obstruction)
  • solid-organ transplant recipients
  • use of non-steroidal inflammatory drugs within 72 hours before right heart catheterization

Heart failure cohort:

Exclusion criteria same as in the discovery cohort except pre-existing acute kidney injury

  • Patients with mechanical assist devices are excluded

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pulmonary hypertension cohort
Consecutive adult Pulmonology inpatients with suspected or pre-diagnosed pulmonary hypertension undergoing invasive right heart catheterization.
Diagnostic test: No intervention
No intervention
Heart failure cohort
Consecutive adult Cardiology inpatients with a new or pre-existing diagnosis of heart failure who are referred to the consultant nephrologist with a history of diuretic-resistant fluid overload and impaired renal function.
Diagnostic test: No intervention
No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of pulmonary hypertension-related morbidity and all-cause mortality (pulmonary hypertension cohort)
Time Frame: 1 year post-discharge
Any hospitalization for worsening of pulmonary hypertension, lung transplantation, or need for escalation of pulmonary hypertension-specific therapy, and death from any cause
1 year post-discharge
First occurrence of worsening heart failure and first occurrence of need for renal replacement therapy (heart failure cohort)
Time Frame: 1 year post-discharge
Unscheduled hospitalization or unscheduled office visit for heart failure and new onset renal replacement therapy
1 year post-discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Giessen

Investigators

  • Study Director: Werner Seeger, MD, Department of Internal Medicine II; Division of Pulmonology, Nephrology and Critical Care Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

November 1, 2016

Primary Completion (Actual)

March 30, 2018

Study Completion (Actual)

September 30, 2019

Study Registration Dates

First Submitted

January 29, 2017

First Submitted That Met QC Criteria

January 30, 2017

First Posted (Estimate)

February 1, 2017

Study Record Updates

Last Update Posted (Actual)

February 18, 2020

Last Update Submitted That Met QC Criteria

February 16, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AZ 237/16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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