Idiopathic Pre-capillary Pulmonary Hypertension in ESKD Patients

April 14, 2016 updated by: Masato Nishimura, MD, Toujinkai Hospital

Idiopathic Pre-capillary Pulmonary Hypertension in Patients With End-stage Kidney Disease

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

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

1988

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of patients of idiopathic pre-capillary hypertension
Time Frame: 14 years
14 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of patients who died of heart failure
Time Frame: 14 years
14 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Toujinkai Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2001

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

April 6, 2016

First Submitted That Met QC Criteria

April 14, 2016

First Posted (Estimate)

April 19, 2016

Study Record Updates

Last Update Posted (Estimate)

April 19, 2016

Last Update Submitted That Met QC Criteria

April 14, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PHdialysis

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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