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Trial record 2 of 4 for:    8532025 [PUBMED-IDS]

Effects of Treprostinil on Right Ventricular Structure and Function in Patients With Pulmonary Arterial Hypertension

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ClinicalTrials.gov Identifier: NCT03835676
Recruitment Status : Recruiting
First Posted : February 8, 2019
Last Update Posted : August 16, 2019
Sponsor:
Information provided by (Responsible Party):
Magdi H. Yacoub, Magdi Yacoub Heart Foundation

Brief Summary:
In a group of patients with PAH treated with treprostinil, the current study aims to investigate the effect of treatment on RV structure and function; and correlate changes in RV structure and function with: World Health Organisation (WHO) class, Six-minute walk test, Quality of life (QoL), and Pre-specified biomarkers (N-terminal B-type natriuretic peptide (NT-ProBNP), Tissue growth factor-B B-type natriuretic peptide BNP, and Profibrotic markers)

Condition or disease Intervention/treatment Phase
Pulmonary Hypertension Drug: Treprostinil Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Intervention Model Description: In a group of patients with PAH treated with treprostinil, the current study aims to investigate the effect of treatment on RV structure and function; and correlate changes in RV structure and function with: WHO class, Six-minute walk test, Quality of life (QoL), and Pre-specified biomarkers (NT-ProBNP, Tissue growth factor-B BNP, and Profibrotic markers)
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Effects of Treprostinil on Right Ventricular Structure and Function in Patients With Pulmonary Arterial Hypertension
Actual Study Start Date : May 1, 2019
Estimated Primary Completion Date : June 1, 2022
Estimated Study Completion Date : December 1, 2025


Arm Intervention/treatment
Experimental: Pulmonary hypertension treated with Treprostinil
Thirty patients who will be treated with Treprostinil.
Drug: Treprostinil

After inclusion and baseline measurements, patients will receive treprostinil in addition to background therapy for 24 months. Follow-up assessment will include:

  • Clinical, echocardiographic, laboratory assessments will be repeated at 1, 3, 6, 12, 18, and 24 month (or when there is clinical indication)
  • CMR will be performed at 6 monthly intervals for 2 years.
  • Peak power output at 6,12, 18 and 24 month
  • Right-side cardiac catheterization will be performed at 6, 12 , 18 and 24 months (or when there is clinical indication)
Other Name: Remodulin




Primary Outcome Measures :
  1. Assessment of Treprostinil effects on right ventricular structure and function using echocardiography [ Time Frame: through study completion, an average of 5 years ]
    Assessment of RV structure and function by echocardiography

  2. Assessment of Treprostinil effects on right ventricular structure and function using Cardiac Magnetic Resonance Imaging (CMR). [ Time Frame: through study completion, an average of 5 years ]
    Assessment of RV structure and function by cardiac magnetic resonance imaging (CMR).


Secondary Outcome Measures :
  1. Correlate changes in RV structure and function with World Health Organisation (WHO) Class. [ Time Frame: through study completion, an average of 5 years ]
    correlate changes in RV structure and function with the WHO class.

  2. Correlate changes in RV structure and function with the Six-minute walk test results [ Time Frame: through study completion, an average of 5 years ]
    correlate changes in RV structure and function with the Six-minute walk test results

  3. Correlate changes in RV structure and function with QoL [ Time Frame: through study completion, an average of 5 years ]
    correlate changes in RV structure and function with the Quality of life (QoL)

  4. Correlate changes in RV structure and function with prespecified biomarkers [ Time Frame: through study completion, an average of 5 years ]
    correlate changes in RV structure and function with the Pre-specified biomarkers (NT-ProBNP, Tissue growth factor-B BNP, and Profibrotic markers)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • Inclusion Criteria:

    • PAH defined as a mean pulmonary artery pressure >25 mmHg on right heart catheterization at rest in the setting of a normal pulmonary arterial wedge pressure ≤15 mm Hg
    • PAH that is idiopathic, familial, or associated with connective tissue disease.
    • WHO class III or class IV despite the use of Endothelin receptor antagonists (ERA) and/or phosphodiesterase-5 inhibitors
    • Age > 18 years
    • Sinus rhythm
  • Exclusion Criteria:

    • Patients with PAH associated with HIV infection, portal hypertension, congenital heart disease, schistosomiasis, chronic haemolytic anaemia
    • Patients with pulmonary hypertension due to veno-occlusive disease and/or pulmonarycapillary haemangiomatosis, thromboembolism.
    • Patients with left side heart disease that may contribute to pulmonary hypertension. Those patients are identified by having pulmonary wedge pressure >15 mmHg or elevated Left Ventricle (LV) end-diastolic pressure
    • Patients who are severely disabled and will not be able to complete the study
    • Patients with significant lung disease as shown by forced vital capacity (FVC) < 70% predicted, or forced expiratory volume at one second (FEV1)/FVC < 50% - Life expectancy <1 year due to severe PAH or any other forms of terminal disease.
    • Pregnant women
    • Refusal to give informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03835676


Contacts
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Contact: Ahmed M ElGuindy, MD, MRCP +201001615151 ahmed_elguindy@hotmail.com
Contact: Shehab M Anwer, MBBCh., MRes +41788816333 shehabanwer@gmail.com

Locations
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Egypt
Aswan Heart Centre - Magdi Yacoub Heart Foundation Recruiting
Aswan, Egypt
Contact: Ahmed M ElGuindy, MD, MRCP    +201001615151    ahmed_elguindy@hotmail.com   
Contact: Shehab M Anwer, MBBCh, MRes, PhD    +41788816333    shehabanwer@gmail.com   
Principal Investigator: Magdi H Yacoub, OM FRS         
Sponsors and Collaborators
Magdi H. Yacoub
Investigators
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Study Chair: Magdi H Yacoub, OM FRS Magdi Yacoub Heart Foundation - Aswan Heart Centre

Publications:

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Responsible Party: Magdi H. Yacoub, Principal Investigator - Sir. Prof., OM FRS, Magdi Yacoub Heart Foundation
ClinicalTrials.gov Identifier: NCT03835676     History of Changes
Other Study ID Numbers: Treprostinil RV
First Posted: February 8, 2019    Key Record Dates
Last Update Posted: August 16, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Magdi H. Yacoub, Magdi Yacoub Heart Foundation:
Pulmonary hypertension
Right ventricular function
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Hypertension
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Treprostinil
Antihypertensive Agents