Treatment with Sildenafil in patients with heart failure

• Conditions: To investigate acute effects of sildenafil on cardiac hemodynamics, right ventricle performance and cGMP concentrations in heart failure patients with preserved ejection fraction and patients after heart transplantation; MedDRA version: 16.0Level: LLTClassification code 10037406Term: Pulmonary hypertension secondarySystem Organ Class: 100000004855; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2013-001659-10-BE
• Lead Sponsor: ZLeuven

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05-21
• Last Update Posted: 11 August 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

-Have LVEF > 45%
-During last 12 months
oWere hospitalized for heart decompensation and/or needed IV diuretics use
OR
oWere catheterized for dyspnea and presented with PCWP > 15 mmHg and/or LVEDP > 18 mmHg
OR
oAre on the chronic diuretics treatment and on the echocardiography have:
?E/E’ > 15
?8 < E/E’ < 15 and
•E/A < 0.5 and DT> 280 ms OR
•Ard-Ad > 30 msOR
•LAVI > 40 ml/m²OR
•LVMI > 122 g/m² (F) or > 149 g/m² (M) OR
•AF OR
•NT-ProBNP> 400 pg/ml
For heart transplant patients
HTX patients with dyspnea and/or chronic diuretics treatment who
-Have LVEF > 45%
-During last 12 months presented with PCWP > 15 mmHg and/or LVEDP > 18 mmHg on the right heart catheterization (RHC)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

-Patients under 18 years of age
-Pregnancy
-Patients with severe valvular insufficiencies en stenosis
-Patients with the history of left ventricular dysfunction with LVEF< 45%

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified