The power and the flow: raising the bars in the treatment of pulmonary arterial hypertension

The power and the flow: raising the bars in the treatment of pulmonary arterial hypertension - GOSPEL: Goal Oriented Strategy to Preserve Ejection Fraction trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON40011

Enrollment

Registered

2013-04-24

Start date

2013-05-17

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pulmonary arterial hypertension

Interventions

Not applicable.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: -Idiopathic or heritable pulmonary arterial hypertension -NYHA functional class II and III -Age 18-80 years

Exclusion criteria

Exclusion criteria: -Other causes of pulmonary arterial hypertension (PAH) (i.e. collagen vascular disease, congenital heart disease, chrono-thromboembolic pulmonary hypertension, pulmonary venous hypertension, left heart failure, hypoxemic lung disease) -PAH targeted therapies before study inclusion

Design outcomes

Primary

Measure	Time frame
The primary endpoint will be preservation/improvement of RVEF after 1 year of follow-up. RVEF will be measured at baseline and after 4, 8, 12 and 24 months of follow-up. In case of decrease in RVEF >3% compared to the previous measurement, additional medical treatment will be applied. Our hypothesis will be proven to be correct when the additional medical treatment result in improved RVEF during the subsequent follow-up measurement.	—

Measure

Time frame

The primary endpoint will be preservation/improvement of RVEF after 1 year of follow-up. RVEF will be measured at baseline and after 4, 8, 12 and 24 months of follow-up. In case of decrease in RVEF >3% compared to the previous measurement, additional medical treatment will be applied. Our hypothesis will be proven to be correct when the additional medical treatment result in improved RVEF during the subsequent follow-up measurement.

—

Secondary

Measure	Time frame
Secondary endpoints will be the change in pulmonary vascular resistance, mean pulmonary artery pressure, cardiac output, exercise capacity and NYHA functional class after 1 year of follow-up.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)