Idiopathic Pre-capillary Pulmonary Hypertension in ESKD Patients

NCT02743091 | Completed DMC

• 1 other identifier: PHdialysis
• Study Type: observational
• Target: 1,988
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study investigates the prevalence and prognosis of idiopathic pre-capillary pulmonary hypertension (PH) in patients with end-stage kidney disease (ESKD).

Conditions

Pulmonary Hypertension

Keywords

heart failure; survival; end-stage kidney disease

Outcome Measures

Primary Outcomes (1)

• Number of patients of idiopathic pre-capillary hypertension

  14 years

Secondary Outcomes (1)

• Number of patients who died of heart failure

  14 years

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with ESKD who had received medical treatment at pre-dialysis stage or had undergone maintenance hemodialysis in Toujinkai Hospital from January 1, 2001 to December 31, 2014

You may qualify if:

• Symptoms of dyspnea, hypotension (systolic blood pressure \<90mmHg, or syncope.
• Systolic pressure gradients in tricuspid valve of 40 mmHg or more.
• In right heart catheterization, precapillary PH was defined as mean pulmonary arterial pressure (PAP) ≥25 mmHg, pulmonary vascular resistance (PVR) ≥3 wood unit, and pulmonary artery wedge pressure (PAWP) ≤15 mmHg.

You may not qualify if:

• Patients with systolic left ventricular dysfunction (left ventricular ejection fraction \[LVEF\] \<50%), mitral or aortic regurgitation of grade 2 or more, aortic or mitral surface \<1.5 cm2, severe anemia (blood hemoglobin \<9 g/dl), severe chronic obstructive pulmonary disease defined by percent predicted forced expiratory volume in one second \<60%, or lung fibrosis were not enrolled in this study.
• In right hear catheterization, PAP ≥25 mmHg and PAWP \>15 mmHg were diagnosed as post capillary PH.

Sponsors & Collaborators

• Toujinkai Hospital: lead

Related Publications (1)

• Nishimura M, Tokoro T, Yamazaki S, Hashimoto T, Kobayashi H, Ono T. Idiopathic pre-capillary pulmonary hypertension in patients with end-stage kidney disease: effect of endothelin receptor antagonists. Clin Exp Nephrol. 2017 Dec;21(6):1088-1096. doi: 10.1007/s10157-016-1344-y. Epub 2016 Oct 19.

  PMID: 27757709 DERIVED

MeSH Terms

Conditions

Hypertension, Pulmonary; Heart Failure; Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Cardiovascular Division

Study Record Dates

• First Submitted: April 6, 2016
• First Posted: April 19, 2016
• Study Start: January 1, 2001
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 19, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share