Design deliver and evaluate the effect of a modified home-based pulmonary hypertension exercise programme for individuals with pulmonary hypertension

Mater Misericordiae University Hospital0 sites25 target enrollmentJune 23, 2020

Overview

2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/33972341/ (added 12/05/2021)

Registry

who.int

Start Date

June 23, 2020

End Date

June 1, 2021

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

•1\. Age \>18 years
•2\. PH diagnosed by right heart catheter showing baseline mean pulmonary arterial pressure \=25 mm Hg
•3\. Pulmonary vascular resistance \=240 dyn·s/cm5
•4\. Pulmonary capillary wedge pressure \=15 mmHg
•5\. Receiving optimised conventional PH therapy including intensified treatment with diuretics and, who have been stable for the previous 3 months
•6\. Except for diuretics, medical treatment should not be expected to change during the study period
•7\. Negative pregnancy test (ß\-HCG) at the start of the trial and counselling on the need to avoid pregnancy during the study for women with child\-bearing potential
•8\. Ablility to understand and willing to sign the Informed consent form

•1\. PH of any cause other than permitted in the entry criteria, (e.g., concomitantly to portal hypertension, complex congenital heart disease, reversed shunt and HIV infection)
•2\. Signs of right heart decompensation
•3\. Acute infection and pyrexia
•4\. Change in disease\-targeted therapy within the last 2 months
•5\. Scheduled to receive an investigational drug during the course of the study
•6\. FEV1/FVC \<0\.5, total lung capacity \<70% of the normal value
•7\. Active liver disease, porphyria
•8\. Elevations of serum transaminases \>3 x upper limit of normal (ULN), bilirubin \> 1\.5 x ULN
•9\. Haemoglobin concentration \<75% of the lower limit of normal
•10\. Systolic blood pressure \<85 mmHg