NCT02565030

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 28, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 1, 2015

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

June 24, 2022

Status Verified

June 1, 2022

Enrollment Period

6.7 years

First QC Date

September 28, 2015

Last Update Submit

June 23, 2022

Conditions

Chronic Thromboembolic Pulmonary HypertensionIdiopathic Pulmonary Arterial Hypertension

Keywords

Chronic thromboembolic Pulmonary HypertensionDistal Chronic thromboembolic Pulmonary HypertensionProximal Chronic thromboembolic Pulmonary HypertensionOperable diseaseIn-operable diseasePulmonary EndarterectomyPH specific targeted therapyPhosphodiesterase type 5 InhibitorsEndothelin Receptor AntagonistProstacyclin analoguesSoluble Guanylate cyclase stimulatorSildenafilTadalafilBosentanAmbrisentanMacitentanIloprostRiociguatIdiopathic Pulmonary Arterial Hypertension

Outcome Measures

Primary Outcomes (1)

  • Death

    All patients with CTEPH or IPAH who have been documented as having died between 01/01/2001 and 01/09/2015

    Upto 176 months

Secondary Outcomes (6)

  • Mean Pulmonary Arterial Pressure(mm of Hg)

    Upto 176 months

  • Diffusion across the lung of Carbon Monoxide(mmol/min/KPa)

    Upto 176 months

  • Emphasis 10 Quality Of Life Questionaire Score(0-50)

    Upto 176 months

  • Incremental Shuttle Walk Distance( in metres)

    Upto 176 months

  • World Health Organization Functional Class(I-IV)

    Upto 176 months

  • +1 more secondary outcomes

Study Arms (4)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients referred to Sheffield Pulmonary Vascular Disease Unit from the Midlands , North of England \& Wales.

You may qualify if:

  • 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.

You may not qualify if:

  • Patients with Pulmonary Hypertension who have other causes of pulmonary hypertension in addition to chronic thromboembolic pulmonary hypertension and Idiopathic pulmonary arterial hypertension.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, South Yorkshire, S10 2JF, United Kingdom

Location

Related Publications (7)

  • Riedel M, Stanek V, Widimsky J, Prerovsky I. Longterm follow-up of patients with pulmonary thromboembolism. Late prognosis and evolution of hemodynamic and respiratory data. Chest. 1982 Feb;81(2):151-8. doi: 10.1378/chest.81.2.151.

    PMID: 7056079RESULT

  • J Cannon, K Page, M Roots, A Ponnaberanam, C Tracy, D Taboada Buasso, K Sheares, C Ng, J Dunning, S Tsui, J Pepke-Zaba, D Jenkins.Outcome after Pulmonary Endarterectomy(PEA):Long term followup of UK National Cohort. Thorax 2013;68(Suppl 3):A25-A26.

    RESULT

  • Hurdman J, Condliffe R, Elliot CA, Davies C, Hill C, Wild JM, Capener D, Sephton P, Hamilton N, Armstrong IJ, Billings C, Lawrie A, Sabroe I, Akil M, O'Toole L, Kiely DG. ASPIRE registry: assessing the Spectrum of Pulmonary hypertension Identified at a REferral centre. Eur Respir J. 2012 Apr;39(4):945-55. doi: 10.1183/09031936.00078411. Epub 2011 Sep 1.

    PMID: 21885399RESULT

  • Pepke-Zaba J, Delcroix M, Lang I, Mayer E, Jansa P, Ambroz D, Treacy C, D'Armini AM, Morsolini M, Snijder R, Bresser P, Torbicki A, Kristensen B, Lewczuk J, Simkova I, Barbera JA, de Perrot M, Hoeper MM, Gaine S, Speich R, Gomez-Sanchez MA, Kovacs G, Hamid AM, Jais X, Simonneau G. Chronic thromboembolic pulmonary hypertension (CTEPH): results from an international prospective registry. Circulation. 2011 Nov 1;124(18):1973-81. doi: 10.1161/CIRCULATIONAHA.110.015008. Epub 2011 Oct 3.

    PMID: 21969018RESULT

  • Condliffe R, Kiely DG, Gibbs JS, Corris PA, Peacock AJ, Jenkins DP, Goldsmith K, Coghlan JG, Pepke-Zaba J. Prognostic and aetiological factors in chronic thromboembolic pulmonary hypertension. Eur Respir J. 2009 Feb;33(2):332-8. doi: 10.1183/09031936.00092008. Epub 2008 Oct 1.

    PMID: 18829679RESULT

  • Shahin Y, Alabed S, Alkhanfar D, Tschirren J, Rothman AMK, Condliffe R, Wild JM, Kiely DG, Swift AJ. Quantitative CT Evaluation of Small Pulmonary Vessels Has Functional and Prognostic Value in Pulmonary Hypertension. Radiology. 2022 Nov;305(2):431-440. doi: 10.1148/radiol.210482. Epub 2022 Jul 12.

    PMID: 35819325DERIVED

  • Quadery SR, Swift AJ, Billings CG, Thompson AAR, Elliot CA, Hurdman J, Charalampopoulos A, Sabroe I, Armstrong IJ, Hamilton N, Sephton P, Garrad S, Pepke-Zaba J, Jenkins DP, Screaton N, Rothman AM, Lawrie A, Cleveland T, Thomas S, Rajaram S, Hill C, Davies C, Johns CS, Wild JM, Condliffe R, Kiely DG. The impact of patient choice on survival in chronic thromboembolic pulmonary hypertension. Eur Respir J. 2018 Sep 16;52(3):1800589. doi: 10.1183/13993003.00589-2018. Print 2018 Sep.

    PMID: 30002102DERIVED

MeSH Terms

Conditions

Familial Primary Pulmonary Hypertension

Condition Hierarchy (Ancestors)

Hypertension, PulmonaryLung DiseasesRespiratory Tract Diseases

Study Officials

  • Syed Quadery, MBBS

    Sheffield Teaching Hospitals NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

  • David Kiely, MD

    Sheffield Teaching Hospitals NHS Foundation Trust

    STUDY CHAIR

  • Wild Jim, PhD

    University Of Sheffield, School of Medicine

    STUDY DIRECTOR

  • Andy Swift, MD

    University Of Sheffield , School Of Medicine

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2015

First Posted

October 1, 2015

Study Start

February 1, 2015

Primary Completion

October 1, 2021

Study Completion

October 1, 2021

Last Updated

June 24, 2022

Record last verified: 2022-06

Locations

GB(1)