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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON41571
Enrollment
65
Registered
2015-05-07
Start date
2015-08-25
Completion date
Unknown
Last updated
2024-04-23

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

Conditions

diastolic heart failure = heart failure with preserved ejection fraction =HFPEF

Interventions

Right heart catheterisation, CMR, echocardiography, NT-proBNP and 6MWD at baseline and at follow-up are already part of our routine diagnostic work-up. For the purpose of this study, we will extend

Sponsors

Vrije Universiteit Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Improvement in exercise capacity, as measured by 6-minute walk testing (6MWT) will be used as primary outcome measure.

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)