NCT05861479

Brief Summary

Assessment of the prognostic value of the estimation of plasma volume or its variation in patients with pulmonary arterial hypertension (PAH) or chronic thromboembolic pulmonary hypertension (CTEPH) after acute right heart failure.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

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

January 1, 2015

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 5, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 17, 2023

Completed
Last Updated

May 17, 2023

Status Verified

April 1, 2023

Enrollment Period

8 years

First QC Date

May 5, 2023

Last Update Submit

May 5, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • Survival

    Death

    From the first visit to 1st April 2023

  • Recurrence of acute right heart failure

    Hospital admission for acute right heart failure

    From the first visit to 1st April 2023

  • Acute right heart failure-free survival

    First event: death or hospital admission for acute right heart failure

    From the first visit to 1st April 2023

Eligibility Criteria

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

One hundred patients with idiopathic, heritable, drug-induced, connective tissue disease-associated, porto-pulmonary or HIV-associated disease were enrolled. At the diagnosis visit, mean±SD age was 59±12 years, 56% of the patients were women and most patients were in World Health Organization/New York Heart Association (WHO/NYHA) Functional Class III or IV.

You may qualify if:

  • Patients with confirmed diagnosis of PAH or CTEPH, referred to the medical department of the investigators
  • Patient with acute right heart failure defined by at least 2 of the following clinical features: worsening of peripheral oedema, development or increase of ascites, weight gain of more than 2.5 kg in 1 week preceding the visit and decline in one NYHA functional class compared to the previous stable state

You may not qualify if:

  • \) Patients with another cause of pulmonary hypertension than PAH or CTEPH, either groups 2, 3 or 5 of the current clinical classification of pulmonary hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Condition Hierarchy (Ancestors)

Hypertension, PulmonaryLung DiseasesRespiratory Tract Diseases

Study Design

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

Study Record Dates

First Submitted

May 5, 2023

First Posted

May 17, 2023

Study Start

January 1, 2015

Primary Completion

January 1, 2023

Study Completion

April 1, 2023

Last Updated

May 17, 2023

Record last verified: 2023-04