Idiopathic Pre-capillary Pulmonary Hypertension in ESKD Patients

NCT ID: NCT02743091

Last Updated: 2016-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

1988 participants

Study Classification

OBSERVATIONAL

Study Start Date

2001-01-31

Study Completion Date

2015-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Pulmonary hypertension (PH) is a rare cardiovascular disease with progressive and fatal features. PH is classified into the 5 groups, and the prevalence of group 1 pulmonary arterial hypertension, including idiopathic and heritable, is 5 to 15 cases per one million adults and a median survival was reportedly three years. PH found in patients with end-stage kidney disease (ESKD) is classified into group 5, because the pathogenesis and clinical characteristics have not been clarified. The prevalence of PH in patients with ESKD was reportedly around 17\~56% based on echocardiographic studies. In this study, we evaluated the incidence of idiopathic pre-capillary PH of ESKD patients by right heart catheterization, and examined the prognosis by following the occurrence of heart failure death.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pulmonary Hypertension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Toujinkai Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Masato Nishimura, MD

Director of Cardiovascular Division

Responsibility Role PRINCIPAL_INVESTIGATOR

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 27757709 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PHdialysis

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Effect of Exercise on Renal Function in Predialysis
NCT02155036 COMPLETED PHASE1/PHASE2