NCT03039959

Brief Summary

Predictive value of renal venous flow profiles for adverse outcomes in patients with right heart failure

Trial Health

87
On Track

Trial Health Score

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

Enrollment
421

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2016

Typical duration for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 29, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 1, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2018

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
Last Updated

February 18, 2020

Status Verified

February 1, 2020

Enrollment Period

1.4 years

First QC Date

January 29, 2017

Last Update Submit

February 16, 2020

Conditions

Pulmonary HypertensionCardiorenal SyndromeHeart Failure

Keywords

Renal Doppler ultrasonographyVenous Congestion

Outcome Measures

Primary Outcomes (2)

  • Rate of pulmonary hypertension-related morbidity and all-cause mortality (pulmonary hypertension cohort)

    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)

    Unscheduled hospitalization or unscheduled office visit for heart failure and new onset renal replacement therapy

    1 year post-discharge

Study Arms (2)

Pulmonary hypertension cohort

Consecutive adult Pulmonology inpatients with suspected or pre-diagnosed pulmonary hypertension undergoing invasive right heart catheterization.

Diagnostic Test: 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

Interventions

No interventionDIAGNOSTIC_TEST

No intervention

Heart failure cohortPulmonary hypertension cohort

Eligibility Criteria

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

You may not qualify if:

  • 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:
  • Patients with mechanical assist devices are excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Clinic Giessen and Marburg - Campus Giessen

Giessen, Hesse, 35392, Germany

Location

Related Publications (6)

  • Navaneethan SD, Wehbe E, Heresi GA, Gaur V, Minai OA, Arrigain S, Nally JV Jr, Schold JD, Rahman M, Dweik RA. Presence and outcomes of kidney disease in patients with pulmonary hypertension. Clin J Am Soc Nephrol. 2014 May;9(5):855-63. doi: 10.2215/CJN.10191013. Epub 2014 Feb 27.

    PMID: 24578332RESULT

  • Iida N, Seo Y, Sai S, Machino-Ohtsuka T, Yamamoto M, Ishizu T, Kawakami Y, Aonuma K. Clinical Implications of Intrarenal Hemodynamic Evaluation by Doppler Ultrasonography in Heart Failure. JACC Heart Fail. 2016 Aug;4(8):674-82. doi: 10.1016/j.jchf.2016.03.016. Epub 2016 May 11.

    PMID: 27179835RESULT

  • Sugiura T, Wada A. Resistive index predicts renal prognosis in chronic kidney disease. Nephrol Dial Transplant. 2009 Sep;24(9):2780-5. doi: 10.1093/ndt/gfp121. Epub 2009 Mar 23.

    PMID: 19318356RESULT

  • Kuhnert S, Sommerlad J, Gall H, Weder MM, Wolff M, Eberle S, Sander M, Reichert M, Koch C, Askevold I, Hecker A, Padberg W, Ostermann M, Mehta R, Ronco C, Birk HW, Seeger W, Mayer K, Hecker M, Husain-Syed F. Postoperative Fluid Accumulation is Associated With Underestimation of AKI Severity in Lung Transplant Recipients. Clin Transplant. 2024 Sep;38(9):e15457. doi: 10.1111/ctr.15457.

    PMID: 39282762DERIVED

  • Husain-Syed F, Singam NSV, Viehman JK, Vaughan L, Bauer P, Gall H, Tello K, Richter MJ, Yogeswaran A, Romero-Gonzalez G, Rosner MH, Ronco C, Assmus B, Ghofrani HA, Seeger W, Birk HW, Kashani KB. Changes in Doppler-Derived Kidney Venous Flow and Adverse Cardiorenal Outcomes in Patients With Heart Failure. J Am Heart Assoc. 2023 Aug 15;12(16):e030145. doi: 10.1161/JAHA.123.030145. Epub 2023 Aug 14.

    PMID: 37577933DERIVED

  • Husain-Syed F, Birk HW, Ronco C, Schormann T, Tello K, Richter MJ, Wilhelm J, Sommer N, Steyerberg E, Bauer P, Walmrath HD, Seeger W, McCullough PA, Gall H, Ghofrani HA. Doppler-Derived Renal Venous Stasis Index in the Prognosis of Right Heart Failure. J Am Heart Assoc. 2019 Nov 5;8(21):e013584. doi: 10.1161/JAHA.119.013584. Epub 2019 Oct 19.

    PMID: 31630601DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Only residual material will be reserved for the Deutsche Zentrum für Lungenforschung Biobank

MeSH Terms

Conditions

Hypertension, PulmonaryCardio-Renal SyndromeHeart FailureHyperemia

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular DiseasesRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesHeart Diseases

Study Officials

  • Werner Seeger, MD

    Department of Internal Medicine II; Division of Pulmonology, Nephrology and Critical Care Medicine

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
18 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Physician Nephrology

Study Record Dates

First Submitted

January 29, 2017

First Posted

February 1, 2017

Study Start

November 1, 2016

Primary Completion

March 30, 2018

Study Completion

September 30, 2019

Last Updated

February 18, 2020

Record last verified: 2020-02

Locations

DE(1)