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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03039959
• Other study ID #: AZ 237/16
• Status: Completed
• Start date: November 2016
• Est. completion date: September 30, 2019

Study information

• Verified date: February 2020
• Source: University of Giessen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 421
• Est. completion date: September 30, 2019
• Est. primary completion date: March 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardio-Renal Syndrome
• Cardiorenal Syndrome
• Heart Failure
• Hypertension, Pulmonary
• Pulmonary Hypertension

Intervention

Diagnostic Test:
• No intervention
No intervention

Locations

Country	Name	City	State
Germany	University Clinic Giessen and Marburg - Campus Giessen	Giessen	Hessen

Sponsors (1)

Lead Sponsor	Collaborator
University of Giessen

Country where clinical trial is conducted

Germany, 

References & Publications (3)

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 — View 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.10 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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