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Completed

NCT Number: NCT03039959

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

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Diagnostic Test

No intervention

Primary outcomes

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

    Time frame: 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

  2. First occurrence of worsening heart failure and first occurrence of need for renal replacement therapy (heart failure cohort)

    Time frame: 1 year post-discharge

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

Sponsors and collaborators

Lead sponsor

University of Giessen

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Feb 1, 2017
Registry last updated
Feb 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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