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CLINICAL TRIALS : SPVU STUDIES

SPVU STUDIES


An observational real world study of transition from Flolan-10.5 to Flolan-12 in a national PH centre

Hypothesis: That patients would prefer the novel Flolan-12 formulation and that QOL would be improved.
Primary Outcome: This is principally a retrospective observational study to assess patient tolerability and  preference to the new formulation. This was assessed by using a study specific questionnaire that has previously been used to assess patient preference of Flolan.(S1 questionnaire(1))
Secondary outcomes: As part of routine clinical care the patients had clinical and biochemical parameters assessed at baseline and after 8 weeks on Flolan-12. The principal clinical outcomes were 6 minute walk test, NT-proBNP, Functional class, Borg dyspnoea score. The Quality of Life questionnaire(assessed by EMPHASIS-10) was used to assess patient quality of life. Patients were asked to identify any AEs and SAEs and were asked to rate the specific prostanoid side effects before and after transition
 
 

Study title: Assessing the efficacy of leads V4/3R during cardiopulmonary exercise test to detect right ventricular ischaemia in pre-capillary pulmonary hypertension
 

The study aims to understand if the addition of the V4R and V3R lead in patients with pulmonary hypertension helps to identify right ventricular hypertrophy and ischaemia in those patients. Patients with high blood pressure in the lungs (pulmonary hypertension) develop increased thickness of the main pumping chamber in the right side of the heart. This can also lead to disruption of the blood flow to the right ventricle and can lead to worsening right ventricular function. These patients as part of routine investigations for pulmonary hypertension undergo a bicycle exercise test called a cardiopulmonary exercise test(CPET). They normally have a 12 lead ECG attached to their chest on the left side which measures the electrical activity of the left heart. A 12 –lead ECG records the heart rhythm during CPET, using adhesive electrodes (leads) attached to the chest wall. The standard placement of these leads is on the left chest wall. To look at the right side of the heart, 2 leads (V3R and V4R) will be placed across the right chest wall, allowing better assessment of the electrical activity of the right side of the heart This V4R/V3R lead would be attached on the right side of the chest and will allow better identification of the electrical activity of the right side of the heart. This can be used to measure an increase in the size of the right side of the heart muscle and detect any issue with blood flow to the right side. This may allow a better method of detecting right heart hypertrophy(enlargement) and ischaemia(poor blood supply) and the changes in the electrical activity will be correlated to other measure of disease activity to see if there is a link.
 

 

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