Towards a better understanding of patients in the *TWILIGHT zone* of Pulmonary Hypertension (OPTIEK2)

Completed

• Conditions: diastolic heart failure = heart failure with preserved ejection fraction =HFPEF; 10019280; 10037454

• Registration Number: NL-OMON41571
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 65

Inclusion Criteria

- Referred to the VUmc for analyses of PH;
- Suspected of PAH(PCWP 8-15mmHg) or
- PH secondary to HFPEF (wedge pressure >15mmHg) AND out of proportion PH (defined as pulmonary vascular resistance (PVR) > 3 Woods units (WU) or PVR between 2.5 -3.0 WU AND elevated transpulmonary gradient >12)

Exclusion Criteria

- Hemodynamic instability
- Contra-indication for diagnostic right heart catheterisation, MRI, echocardiography (e.g. pregnancy)
- Other diagnosis than PAH/ diastolic heart failure
- No informed consent for the complete study protocol

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Improvement in exercise capacity, as measured by 6-minute walk testing (6MWT)<br /><br>will be used as primary outcome measure.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Change in PCWP after treatment, as measured by RHC during follow up, will be<br /><br>evaluated as secondary outcome measure. Other physiological parameters of<br /><br>interest are: diastolic pressure gradient, reaction of PCWP to fluid challenge<br /><br>at the time of the first RHC, reaction of PCWP on NO inhalation at first RHC,<br /><br>exercise echocardiography measures, NT-proBNP, cardiac index, LV (diastolic)<br /><br>function, additional CMR measures (including assessment of diastolic strain and<br /><br>left atrial dimensions), use and dosage of diuretics and quality of life.</p><br>