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

NCT ID: NCT03039959

Last Updated: 2020-02-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

421 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-11-30

Study Completion Date

2019-09-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Pulmonary Hypertension Cardiorenal Syndrome Heart Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Pulmonary hypertension cohort

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

No intervention

Intervention Type 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.

No intervention

Intervention Type DIAGNOSTIC_TEST

No intervention

Interventions

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No intervention

No intervention

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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:


* Patients with mechanical assist devices are excluded
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Giessen

OTHER

Sponsor Role lead

Responsible Party

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Faeq Husain

Senior Physician Nephrology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Werner Seeger, MD

Role: STUDY_DIRECTOR

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

Locations

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University Clinic Giessen and Marburg - Campus Giessen

Giessen, Hesse, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type RESULT
PMID: 24578332 (View on PubMed)

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.

Reference Type RESULT
PMID: 27179835 (View on PubMed)

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.

Reference Type RESULT
PMID: 19318356 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39282762 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37577933 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31630601 (View on PubMed)

Other Identifiers

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AZ 237/16

Identifier Type: -

Identifier Source: org_study_id

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