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Chronic Thrombo-embolic Pulmonary Hypertension: Classification and Long Term Outcome

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ClinicalTrials.gov Identifier: NCT02565030
Recruitment Status : Active, not recruiting
First Posted : October 1, 2015
Last Update Posted : June 14, 2018
Sponsor:
Collaborator:
University of Sheffield
Information provided by (Responsible Party):
Sheffield Teaching Hospitals NHS Foundation Trust

Tracking Information
First Submitted Date September 28, 2015
First Posted Date October 1, 2015
Last Update Posted Date June 14, 2018
Actual Study Start Date February 2015
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 29, 2015)
Death [ Time Frame: Upto 176 months ]
All patients with CTEPH or IPAH who have been documented as having died between 01/01/2001 and 01/09/2015
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02565030 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: October 1, 2015)
  • Mean Pulmonary Arterial Pressure(mm of Hg) [ Time Frame: Upto 176 months ]
    Measure of the final Mean Pulmonary Arterial Pressure with Right Heart Catheter studies in patients with CTEPH and IPAH reported between 01/01/2001 and 01/09/2015
  • Diffusion across the lung of Carbon Monoxide(mmol/min/KPa) [ Time Frame: Upto 176 months ]
    Measure of final Diffusion across the lung of Carbon Monoxide in patients with CTEPH & IPAH reported between 01/01/2001 and of 01/09/2015
  • Emphasis 10 Quality Of Life Questionaire Score(0-50) [ Time Frame: Upto 176 months ]
    Measure of the Emphasis 10 Quality of Life Questionaire Score in patients with CTEPH and IPAH in their final clinic visit reported between 01/01/2001 and 01/09//2015
  • Incremental Shuttle Walk Distance( in metres) [ Time Frame: Upto 176 months ]
    The measure of the final Incremental Shuttle Walk Distance of patients with CTEPH and IPAH reported between 01/01/2015 and 01/09/2015
  • World Health Organization Functional Class(I-IV) [ Time Frame: Upto 176 months ]
    Measure of the final World Health Organization Functional Class in patients with CTEPH and IPAH reported between 01/01/2001 and 01/09/2015
  • Right Ventricular Ejection Fraction(%) [ Time Frame: Upto 176 months ]
    Measure of the final Right Ventricular Ejection Fraction with Cardiac Magnetic Resonance Imaging(MRI) in patients with CTEPH and IPAH reported between 01/01/2001 and 01/09/2015
Original Secondary Outcome Measures
 (submitted: September 29, 2015)
  • Mean Pulmonary Arterial Pressure(mm of Hg) [ Time Frame: Upto 176 months ]
    Measure of the final Mean Pulmonary Arterial Pressure with Right Heart Catheter studies in patients with CTEPH and IPAH reported between 01/01/2001 and 01/09/2015
  • Diffussion across the lung of Carbon Monoxide(mmol/min/KPa) [ Time Frame: Upto 176 months ]
    Measure of final Diffussion across the lung of Carbon Monoxide in patients with CTEPH & IPAH reported between 01/01/2001 and of 01/09/2015
  • Emphais 10 Quality Of Life Questionaire Score(0-50) [ Time Frame: Upto 176 months ]
    Measure of the Emphasis 10 Quality of Life Questionaire Score in patients with CTEPH and IPAH in their final clinic visit reported between 01/01/2001 and 01/09//2015
  • Incremental Shuttle Walk Distance( in metres) [ Time Frame: Upto 176 months ]
    The measure of the final Incremental Shuttle Walk Distance of patients with CTEPH and IPAH reported between 01/01/2015 and 01/09/2015
  • World Health Organization Functional Class(I-IV) [ Time Frame: Upto 176 months ]
    Measure of the final World Health Organization Functional Class in patients with CTEPH and IPAH reported beteween 01/01/2001 and 01/09/2015
  • Right Ventricular Ejection Fraction(%) [ Time Frame: Upto 176 months ]
    Measure of the final Right Ventricular Ejection Fraction with Cardiac MRI in patients with CTEPH and IPAH reported between 01/01/2001 and 01/09/2015
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Chronic Thrombo-embolic Pulmonary Hypertension: Classification and Long Term Outcome
Official Title Chronic Thrombo-embolic Pulmonary Hypertension: Classification and Long Term Outcome
Brief Summary This study will help to provide more up to date prognostic data on the natural history of untreated proximal CTEPH which will be helpful in discussions regarding surgical versus medical treatment and by exploring the similarities and differences between distal CTEPH and IPAH the investigators hope to get insights into disease mechanisms in patients with distal CTEPH.
Detailed Description

Chronic thrombo-embolic pulmonary hypertension (CTEPH) is thought to represent the consequence of failure of thrombus resolution after the establishment of thrombosis within the elastic pulmonary arteries. Thrombotic material becomes fibrosed, with occlusive vascular remodeling and the development of a secondary small vessel arteriopathy, termed the two-compartment model. This results in an increase in pressure and vascular resistance in the pulmonary vasculature and leads eventually to right heart failure.

It has been demonstrated that 2 year survival for CTEPH patients with mean pulmonary arterial pressure(mPAP) >50 mm Hg was only 20%, however, preliminary data from Sheffield Teaching Hospitals suggest that survival is significantly better than this. Until recently surgery was the only treatment for CTEPH in selected patients. Studies have shown the 10 year survival in patients with CTEPH after PEA surgery was 74%. More recently, for patients with inoperable CTEPH, drug therapy has been shown to improve exercise capacity. Despite recent publications the natural history and mechanisms underlying CTEPH are poorly understood.

The main area of research focus in this study will be improving understanding of the natural history of chronic thromboembolic pulmonary hypertension. The purpose of this research protocol is to conduct a retrospective review of patients with CTEPH diagnosed at the Sheffield Centre between 2001 and 2014 to understand more about the natural history of disease including prognostic indicators. The Sheffield Service has one of the largest cohorts of CTEPH in the world (>650 diagnosed cases since 2001). Approximately half of these patients undergo curative surgery with pulmonary endarterectomy. However, a significant proportion of patients with operable disease decline surgery and a significant proportion of patients have disease that is too distal for surgery, so called distal CTEPH. There is a relative paucity of data on i) the natural history of this disease, ii) an understanding of the relative contribution of obstruction and distal vasculopathy to elevations in pulmonary vascular resistance iii) the effects of distal CTEPH on right ventricular function and iv) how distal CTEPH differs from idiopathic pulmonary arterial hypertension (IPAH).

The second part of this study will focus on understanding disease mechanisms utilising MR imaging techniques and using the Sheffield PH Biobank resource to understand differences in the IPAH and distal CTEPH cohorts. The Sheffield PH Biobank has samples and detailed phenotypic data on over 400 treatment naïve patients with all forms of pulmonary hypertension with serial sampling and long term follow up providing a unique resource to make detailed comparisons across all forms of pulmonary hypertension.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients referred to Sheffield Pulmonary Vascular Disease Unit from the Midlands , North of England & Wales.
Condition
  • Chronic Thromboembolic Pulmonary Hypertension
  • Idiopathic Pulmonary Arterial Hypertension
Intervention Not Provided
Study Groups/Cohorts
  • CTEPH surgical disease, operated
    Patients with proximal CTEPH who have undergone Pulmonary Endarterectomy (PEA) surgery
  • CTEPH surgical disease, not operated

    Patients with proximal CTEPH with operable distribution of disease& have not undergone PEA surgery due to the following reasons:

    1. Multiple co-morbidities
    2. Patients choice
    3. Mild disease /symptoms
    4. Awaiting Surgery
  • CTEPH non surgical
    Patients with distal CTEPH with inoperable distribution of disease inaccessable to surgery.
  • IPAH
    Patients with IPAH as per European Society of Cardiology(ESC) criteria
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: September 29, 2015)
1200
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 2021
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • All patients with the diagnosis of chronic thromboembolic pulmonary hypertension and Idiopathic pulmonary arterial hypertension (as per the European Society of Cardiology guidelines) who presented to Sheffield Pulmonary Vascular Disease Unit at the Royal Hallamshire Hospital between 1st Jan 2001 and 1st Dec 2014.

Exclusion Criteria:

  • Patients with Pulmonary Hypertension who have other causes of pulmonary hypertension in addition to chronic thromboembolic pulmonary hypertension and Idiopathic pulmonary arterial hypertension.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT02565030
Other Study ID Numbers STH18804
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Sheffield Teaching Hospitals NHS Foundation Trust
Study Sponsor Sheffield Teaching Hospitals NHS Foundation Trust
Collaborators University of Sheffield
Investigators
Principal Investigator: Syed Quadery, MBBS Sheffield Teaching Hospitals NHS Foundation Trust
Study Chair: David Kiely, MD Sheffield Teaching Hospitals NHS Foundation Trust
Study Director: Wild Jim, PhD University Of Sheffield, School of Medicine
Study Director: Andy Swift, MD University Of Sheffield , School Of Medicine
PRS Account Sheffield Teaching Hospitals NHS Foundation Trust
Verification Date June 2018