Treatment with Sildenafil in patients with heart failure

Acute effects of Sildenafil on the hemodynamics, Right Ventricle performance and cyclic GMP concentration in Heart failure patients with preserved left ventricular ejection fraction and patients after heart transplantation (SIRVEH study) - SIRVEH study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-001659-10-BE

Enrollment

Registered

2013-05-21

Start date

2013-08-08

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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: 16.0 Level: LLT Classification code 10037406 Term: Pulmonary hypertension secondary System Organ Class: 100000004855

Interventions

Trade Name: VIAGRA Product Name: VIAGRA Pharmaceutical Form: Tablet Trade Name: Noxap 800ppm mol/mol Product Name: Noxap 800 ppm mol/mol Product Code: not applicable Pharmaceutical Form: Medicinal ga

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Have LVEF > 45% - During last 12 months o Were hospitalized for heart decompensation and/or needed IV diuretics use OR o Were catheterized for dyspnea and presented with PCWP > 15 mmHg and/or LVEDP > 18 mmHg OR o Are on the chronic diuretics treatment and on the echocardiography have: ? E/E’ > 15 ? 8 280 ms OR • Ard-Ad > 30 ms OR • LAVI > 40 ml/m² OR • 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

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%

Design outcomes

Secondary

Measure	Time frame
Secondary end point(s): Correlation of hemodynamic response with: - Presence of fibrosis in right and left ventricle as assessed by MRI, circulating fibrosis biomarkers and expression of PDE5 in myocardium - Exercise capacity - Long function;Timepoint(s) of evaluation of this end point: The blood sample for marker of fibrosis will be taken and stored for future analysis, when we could obtain the funding for it.	—

Measure

Time frame

Secondary end point(s): Correlation of hemodynamic response with: - Presence of fibrosis in right and left ventricle as assessed by MRI, circulating fibrosis biomarkers and expression of PDE5 in myocardium - Exercise capacity - Long function;Timepoint(s) of evaluation of this end point: The blood sample for marker of fibrosis will be taken and stored for future analysis, when we could obtain the funding for it.

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Primary

Measure	Time frame
Main Objective: Acute effects of cardiac hemodynamics, RV performance and cGMP concentration;Secondary Objective: Correlation of hemodynamic response with: -Presence of fibrosis in right and left ventricle as assessed by MRI, circulating fibrosis biomarkers and expression of PDE5 in myocardium -Exercise capacity -Long function;Primary end point(s): The specific aims of our study are: 1.To investigate the effects of single dosis of 50 mg of sildenafil and the additive effect of inhaled NO, on cardiac hemodynamics, RV contractility and blood cGMP concentrations. We aim to establish whether the response of patients to sildenafil would be different depending on the degree of RV failure, RV or LV hypertrophy or fibrosis 2.To investigate the evolution of LV and RV strain and function, as well as pulmonary pressures and pulmonary resistance during bicycle exercise echocardiography 3.To investigate degree of fibrosis by circulating fibrosis markers and cardiac MRI imaging for diffuse fibrosis In the subgroup of HTX patients presenting with HFpEF physiology specific additional aims are: 4.To investigate on myocardial biopsy from the right ventricle the PDE5 expression and relate it to effects of oral sildenafil 5.To analyze the presence of circulating blood markers of fibrosis and to correlate them with presence of fibrosis as assessed by cardiac MRI and myocardial biopsies from RV 6.to perform an unbiased discovery of molecular pathways contributing to HFpEF physiology and PH using high throughput mRNA and microRNA expression analysis of right ventricular biopsy specimens ;Timepoint(s) of evaluation of this end point: Hemodynamic measurements, pressure volume loops of the right ventricle and blood cGMP concentration during three stages: at baseline, 30 minutes after 50 mg sildenafil administration and 15 minutes after NO inhalation (80 ppm).	—

Measure

Time frame

Main Objective: Acute effects of cardiac hemodynamics, RV performance and cGMP concentration;Secondary Objective: Correlation of hemodynamic response with: -Presence of fibrosis in right and left ventricle as assessed by MRI, circulating fibrosis biomarkers and expression of PDE5 in myocardium -Exercise capacity -Long function;Primary end point(s): The specific aims of our study are: 1.To investigate the effects of single dosis of 50 mg of sildenafil and the additive effect of inhaled NO, on cardiac hemodynamics, RV contractility and blood cGMP concentrations. We aim to establish whether the response of patients to sildenafil would be different depending on the degree of RV failure, RV or LV hypertrophy or fibrosis 2.To investigate the evolution of LV and RV strain and function, as well as pulmonary pressures and pulmonary resistance during bicycle exercise echocardiography 3.To investigate degree of fibrosis by circulating fibrosis markers and cardiac MRI imaging for diffuse fibrosis In the subgroup of HTX patients presenting with HFpEF physiology specific additional aims are: 4.To investigate on myocardial biopsy from the right ventricle the PDE5 expression and relate it to effects of oral sildenafil 5.To analyze the presence of circulating blood markers of fibrosis and to correlate them with presence of fibrosis as assessed by cardiac MRI and myocardial biopsies from RV 6.to perform an unbiased discovery of molecular pathways contributing to HFpEF physiology and PH using high throughput mRNA and microRNA expression analysis of right ventricular biopsy specimens ;Timepoint(s) of evaluation of this end point: Hemodynamic measurements, pressure volume loops of the right ventricle and blood cGMP concentration during three stages: at baseline, 30 minutes after 50 mg sildenafil administration and 15 minutes after NO inhalation (80 ppm).

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Countries

Belgium

Contacts

Public Contacthart-en vaatziekten

UZLeuven

cardiologie@uzleuven.be3216344263

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026