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

Completed

• Conditions: Pulmonary Hypertension; Cardiorenal Syndrome; Heart Failure
• Interventions: Diagnostic Test: No intervention

• Registration Number: NCT03039959
• Lead Sponsor: University of Giessen

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.

Study Timeline

• Study Start: 2016-11
• Study First Submitted: 2017-01-29
• Study First Submitted QC: 2017-01-30
• Study First Posted: 2017-02-01
• Primary Completion: 2018-03-30
• Study Completion: 2019-09-30
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-16
• Last Update Posted: 2020-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 421

Inclusion Criteria

Not provided

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pulmonary hypertension cohort	No intervention	Consecutive adult Pulmonology inpatients with suspected or pre-diagnosed pulmonary hypertension undergoing invasive right heart catheterization.
Heart failure cohort	No intervention	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.

Primary Outcome Measures

Name	Time	Method
Rate of pulmonary hypertension-related morbidity and all-cause mortality (pulmonary hypertension cohort)	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
First occurrence of worsening heart failure and first occurrence of need for renal replacement therapy (heart failure cohort)	1 year post-discharge	Unscheduled hospitalization or unscheduled office visit for heart failure and new onset renal replacement therapy

Trial Locations

Locations (1)

University Clinic Giessen and Marburg - Campus Giessen; 🇩🇪 Giessen, Hessen, Germany