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Trial record 48 of 1095 for:    pulmonary hypertension

The Pan African Pulmonary Hypertension Cohort Study (PAPUCO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02265887
Recruitment Status : Completed
First Posted : October 16, 2014
Last Update Posted : August 7, 2015
Sponsor:
Collaborators:
Doula General Hospital, Cameroon
Instituto Nacional de Saúde, Mozambique
Mayo Clinic
Aminu Kano Teaching Hospital
University of Ibadan
Eduardo Mondlane University, Faculty of Medicine, Mozambique
University of Lagos, Nigeria
Khayelitsha District hospital, Cape Town, South Africa
Baker Heart Research Institute, Melbourne, Australia
Pulmonary Vascular Research Institute, UK
Information provided by (Responsible Party):
Prof. Karen Sliwa, University of Cape Town

Brief Summary:
The study will recruit and follow up patients for six months patients newly diagnosed with pulmonary hypertension from twelve centers across four countries; South Africa, Mozambique, Cameroon, Nigeria. The main aim of the study is to describe the aetiology, natural history and management practices of pulmonary hypertension in Africa.

Condition or disease Intervention/treatment
Pulmonary Hypertension Other: standard of care

  Show Detailed Description

Study Type : Observational [Patient Registry]
Actual Enrollment : 254 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: The Pan African Pulmonary Hypertension Cohort Study
Study Start Date : June 2012
Primary Completion Date : December 2013
Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Intervention Details:
    Other: standard of care
    No intervention, this a patient registry and is purely an observational study


Primary Outcome Measures :
  1. mortality [ Time Frame: 6 months ]
    dead or alive status at 6 months post enrolment

  2. To improve performance and functionality [ Time Frame: 6 months ]
    Six minute walk test



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
250 patients with pulmonary hypertension (PHT) who reside in sub-Saharan Africa will be enrolled in the registry
Criteria

Inclusion Criteria:

  • Patients of any age who meet clinical and echocardiographic criteria for the diagnosis of PHT will be included

Exclusion Criteria:

  • Patients who are unable, or unlikely, to return for 6 month follow-up will be excluded

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): NCT02265887


Locations
South Africa
University of Cape Town
Cape Town, Western Cape, South Africa, 7925
Sponsors and Collaborators
University of Cape Town
Doula General Hospital, Cameroon
Instituto Nacional de Saúde, Mozambique
Mayo Clinic
Aminu Kano Teaching Hospital
University of Ibadan
Eduardo Mondlane University, Faculty of Medicine, Mozambique
University of Lagos, Nigeria
Khayelitsha District hospital, Cape Town, South Africa
Baker Heart Research Institute, Melbourne, Australia
Pulmonary Vascular Research Institute, UK
Investigators
Principal Investigator: Karen Sliwa-Hahnle, PhD University of Cape Town

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Karen Sliwa, Professor, University of Cape Town
ClinicalTrials.gov Identifier: NCT02265887     History of Changes
Other Study ID Numbers: 241/2011
First Posted: October 16, 2014    Key Record Dates
Last Update Posted: August 7, 2015
Last Verified: August 2015

Keywords provided by Prof. Karen Sliwa, University of Cape Town:
Pulmonary Hypertension
Africa
Heart Disease
Echocardiography

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases