diastolic heart failure = heart failure with preserved ejection fraction =HFPEF
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time frame |
|---|---|
| Improvement in exercise capacity, as measured by 6-minute walk testing (6MWT) will be used as primary outcome measure. | — |
Secondary
| Measure | Time 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