NCT02265887

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
254

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2012

Typical duration 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

June 1, 2012

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 10, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 16, 2014

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

August 7, 2015

Status Verified

August 1, 2015

Enrollment Period

1.5 years

First QC Date

October 10, 2014

Last Update Submit

August 6, 2015

Conditions

Keywords

Pulmonary HypertensionAfricaHeart DiseaseEchocardiography

Outcome Measures

Primary Outcomes (2)

  • mortality

    dead or alive status at 6 months post enrolment

    6 months

  • To improve performance and functionality

    Six minute walk test

    6 months

Interventions

No intervention, this a patient registry and is purely an observational study

Eligibility Criteria

Age1 Year+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

250 patients with pulmonary hypertension (PHT) who reside in sub-Saharan Africa will be enrolled in the registry

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Cape Town

Cape Town, Western Cape, 7925, South Africa

Location

Related Publications (1)

  • Thienemann F, Dzudie A, Mocumbi AO, Blauwet L, Sani MU, Karaye KM, Ogah OS, Mbanze I, Mbakwem A, Udo P, Tibazarwa K, Damasceno A, Keates AK, Stewart S, Sliwa K. The causes, treatment, and outcome of pulmonary hypertension in Africa: Insights from the Pan African Pulmonary Hypertension Cohort (PAPUCO) Registry. Int J Cardiol. 2016 Oct 15;221:205-11. doi: 10.1016/j.ijcard.2016.06.242. Epub 2016 Jun 29.

MeSH Terms

Conditions

Hypertension, PulmonaryHeart Diseases

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Karen Sliwa-Hahnle, PhD

    University of Cape Town

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 10, 2014

First Posted

October 16, 2014

Study Start

June 1, 2012

Primary Completion

December 1, 2013

Study Completion

June 1, 2015

Last Updated

August 7, 2015

Record last verified: 2015-08

Locations