Pulmonary HypertensionNCT02743091
Idiopathic Pre-capillary Pulmonary Hypertension in ESKD Patients
An observational study of Pulmonary Hypertension, run by Toujinkai Hospital.
Trial summary
This study investigates the prevalence and prognosis of idiopathic pre-capillary pulmonary hypertension (PH) in patients with end-stage kidney disease (ESKD). Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Pulmonary Hypertension
- How many people
- 1,988 participants
- Where
- No sites listed yet
- Study dates
- Jan 2001to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: 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).
Read the 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.
- Conditions
- Pulmonary Hypertension
- Keywords
- heart failure, survival, end-stage kidney disease
- Medical subject headings
- Hypertension, Pulmonary, Heart Failure, Kidney Failure, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients of idiopathic pre-capillary hypertension
Measured: 14 years
Secondary outcomes (1)
Number of patients who died of heart failure
Measured: 14 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2016 (estimated)
- Study startJan 2001
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 1,988 participants (actual)
Sponsor and investigators
- Lead sponsor
- Toujinkai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Masato Nishimura, MD, Toujinkai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02743091
- Sponsor's protocol ID
- PHdialysis
- Status last verified
- Apr 2016
- First submitted
- 6 Apr 2016
- Last updated
- 19 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 27757709
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Idiopathic Pre-capillary Pulmonary Hypertension in Patients With End-stage Kidney Disease
- ClinicalTrials.gov ID
- NCT02743091
- Acronym / sponsor ID
- PHdialysis
- Conditions
- Pulmonary Hypertension
- Keywords
- heart failure, survival, end-stage kidney disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,988 participants (actual)
- Lead sponsor
- Toujinkai HospitalUniversity, hospital or other
- Study start
- Jan 2001
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 19 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates the prevalence and prognosis of idiopathic pre-capillary pulmonary hypertension (PH) in patients with end-stage kidney disease (ESKD).
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patients of idiopathic pre-capillary hypertension
Time frame: 14 years
1 secondary outcome
Number of patients who died of heart failure
Time frame: 14 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2016.
- Derived from this study: PubMed 27757709Nishimura 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Hypertension, run by Toujinkai Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients of idiopathic pre-capillary hypertension (time frame: 14 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02743091, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2016.