Heart Failure Clinical Trial
Official title:
Predictive Value of Renal Venous Flow Profiles for Adverse Outcomes in Right Heart Failure
NCT number | NCT03039959 |
Other study ID # | AZ 237/16 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | November 2016 |
Est. completion date | September 30, 2019 |
Verified date | February 2020 |
Source | University of Giessen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
Predictive value of renal venous flow profiles for adverse outcomes in patients with right heart failure
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 |
Country | Name | City | State |
---|---|---|---|
Germany | University Clinic Giessen and Marburg - Campus Giessen | Giessen | Hessen |
Lead Sponsor | Collaborator |
---|---|
University of Giessen |
Germany,
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
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 |
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