Ignite Creation Date:
2024-05-05 @ 10:39 PM
Last Modification Date:
2024-10-26 @ 10:22 AM
Study NCT ID:
NCT01156636
Status:
COMPLETED
Last Update Posted:
2012-06-15
First Post:
2010-07-02
Brief Title:
Phosphodiesterase-5 PDE5 Inhibition and Pulmonary Hypertension in Diastolic Heart Failure
Sponsor:
University of Milan
Organization:
University of Milan
Study Overview
Official Title:
Pulmonary Hypertension Secondary to Heart Failure With Preserved Systolic Function a Target of Phosphodiesterase - 5 Inhibition in a 1- Year Duration Study
Status:
COMPLETED
Status Verified Date:
2009-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Prevalence of heart failure HF with left ventricular LV diastolic dysfunction and preserved ejection fraction EF HFpEF is increasing Prognosis worsens with development of pulmonary vasoconstriction and hypertension PH and right ventricular RV failure The investigators aimed at modulating pulmonary vascular tone and RV burden in HFpEF due to high blood pressure HBP by using the phosphodiesterase-5 PDE5 inhibitor sildenafil
Detailed Description:
Heart failure HF with preserved left ventricular LV ejection fraction EF HFpEF is a public health problem and a major topic in clinical cardiology Its prevalence in fact is increasing and the outcome seems to be similar to that of HF with LV systolic dysfunction LVSD Pulmonary hypertension PH in HFpEF is highly prevalent and often severe and like in LVSD 3 is a predictor of morbidity and mortality 4 Because of the thin wall and the distensibility the right ventricle RV is much more vulnerable by an excessive afterload than by preload The pulmonary circulation is a central determinant of RV afterload and an increase in impendance to RV ejection like occurring in LV dysfunction can easily result in RV failure tricuspid regurgitation central venous pressure CVP rise Development of RV failure is unanimously viewed as a predictor of poor prognosis but the underlying mechanisms have not been extensively investigated
Because of the prevalence and clinical significance of PH secondary to HF attenuation of the pulmonary vascular tone and of the RV hemodynamic burden has been suggested as a goal to be achieved with HF therapy Attempts with endothelin receptor antagonists or prostacyclin analogues were basically unsuccessful Experimental models and human studies showing that in HF nitric oxide NO - dependent pulmonary vasodilatation is impaired and pulmonary vascular resistance elevation is at least in part due to pulmonary endothelial dysfunction have suggested therapeutic strategies with agents that increase NO activity like nitrates or phosphodiesterase - 5 PDE5 inhibitors 12-14 The latter agents offer the double advantage of selectively dilating the pulmonary vessels and not producing tachyphylaxis
In this 1-year duration study the primary end-point was to probe whether pulmonary hemodynamics and RV performance in HFpEF with PH may be targets of PDE5 inhibition with sildenafil
Because of the prevalence and clinical significance of PH secondary to HF attenuation of the pulmonary vascular tone and of the RV hemodynamic burden has been suggested as a goal to be achieved with HF therapy Attempts with endothelin receptor antagonists or prostacyclin analogues were basically unsuccessful Experimental models and human studies showing that in HF nitric oxide NO - dependent pulmonary vasodilatation is impaired and pulmonary vascular resistance elevation is at least in part due to pulmonary endothelial dysfunction have suggested therapeutic strategies with agents that increase NO activity like nitrates or phosphodiesterase - 5 PDE5 inhibitors 12-14 The latter agents offer the double advantage of selectively dilating the pulmonary vessels and not producing tachyphylaxis
In this 1-year duration study the primary end-point was to probe whether pulmonary hemodynamics and RV performance in HFpEF with PH may be targets of PDE5 inhibition with sildenafil
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None