Clinical trial NCT03039959: Predictive Value of Renal Venous Flow Profiles for Adverse Outcomes in Right Heart Failure
Official title: Predictive Value of Renal Venous Flow Profiles for Adverse Outcomes in Right Heart Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Hypertension
Cardiorenal Syndrome
Heart Failure
Keywords: Renal Doppler ultrasonography
Venous Congestion
Lead sponsor: University of Giessen
Sponsor class: OTHER
First posted: 2017-02-01
Enrollment: 421
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of pulmonary hypertension-related morbidity and all-cause mortality (pulmonary hypertension cohort)
timeFrame: 1 year post-discharge
measure: First occurrence of worsening heart failure and first occurrence of need for renal replacement therapy (heart failure cohort)
timeFrame: 1 year post-discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Giessen
country: Germany
facility: University Clinic Giessen and Marburg - Campus Giessen
state: Hessen
Study officials:
affiliation: Department of Internal Medicine II; Division of Pulmonology, Nephrology and Critical Care Medicine
name: Werner Seeger, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.