Single-ventriclePhase 3VU-INHIBNCT03997097
Efficacy of Phosphodiesterase-type 5 Inhibitors in Patients With Univentricular Congenital Heart Disease
A Phase 3 study testing Sildenafil in people with Single-ventricle and Pulmonary Hypertension, run by University Hospital, Montpellier.
Trial summary
In univentricular hearts, selective lung vasodilators such as phosphodiesterase type 5 (PDE5) inhibitors would decrease pulmonary resistance and improve exercise tolerance. However, the level of evidence for the use of PDE5 inhibitors in patients with a single ventricle (SV) remains limited. Read more about this study
- Who is it for?
- Ages 15 to 80 years
- Conditions the study is for
- Single-ventricle, Pulmonary Hypertension, Univentricular Heart
- What is being tested?
- Sildenafil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2023to 1 Jun 2028
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 15 years of age and over.
- Patient's weight over 20 kg
- Patients with CHD with a single ventricular type defined by the classification of congenital heart diseases in Orphanet (53).
- PAH defined by diagnostic catheterization with mean PAP > 15 mmHg and a trans-pulmonary gradient > 5 mmHg, performed as part of the usual follow-up. No definition of PAH in SV is available as a result of a particular physiology. Therefore, we chose the 15mmHg cut-off, which is used in clinical routine to allow or contra-indicate the Fontan procedure [50,51].
- Appropriate written informed consent (adult patients, legal parents for teenagers), and formal assent (teenagers), should to be provided.
- Beneficiary of a health insurance.
Who cannot join
- Patient who is unable to perform a cardio-pulmonary exercise test.
- Cardiac surgery planned during the trial.
- Patient treated by any pulmonary arterial vasodilator drug, as defined in the 2015 PH guidelines (52), within 6 months before inclusion, regardless the duration and the type(s) (oral, intravenous, subcutaneous, inhaled) of administration.
- Patient treated by Sildenafil or any other type of phosphodiesterase-type 5 inhibitor (such as tadalafil) within 6 months before inclusion, regardless the duration of administration.
- Interventional cardiac catheterization planned during the trial (collateral occlusion, fenestration occlusion, stenting, angioplasty, ablation of rhythm disorder), other than during the screening.
- Participation in another clinical trial or administration of an off-label drug in the 4 weeks preceding the screening.
Show all 19Show fewer
- Pregnancy, desire for pregnancy, absence of contraception during the study period.
- Severe hepatic insufficiency (Child-Pugh C class).
- Hypersensitivity to the active substance or to any of the excipients of the tablet:
- microcrystalline cellulose, calcium hydrogen phosphate anhydrous, croscarmellose sodium, stearate of magnesium, hypromellose, titanium dioxide (E171), monohydrate lactose, glycerol triacetate.
- Combination with products called "nitric oxide donors" (such as amyl nitrite) or with nitrates in any form, due to the hypotensive effects of nitrates.
- Concomitant administration of PDE5 inhibitors, such as Sildenafil, with guanylate cyclase stimulators, such as Riociguat.
- Combination with the most potent inhibitors of CYP3A4 (eg ketoconazole, itraconazole, ritonavir).
- Disposition to priapism, sclerosis of corpora cavernosa, disease of La Peyronie, sickle cell anemia, multiple myeloma, leukemia.
- Uncontrolled hypotension or risk of hypotension: water depletion, obstruction to ejection of the left ventricle, dysfunction of the autonomic nervous system, patient under alpha-blocker.
- Severe cardiovascular events, recent (<3 months) or not stabilized: myocardial infarction, unstable angina, sudden cardiac death, ventricular arrhythmia, cerebrovascular hemorrhage.
- Active hemorrhagic disorders.
- Active gastro-duodenal ulcer.
- Patients with loss of vision of an eye due to non-arteritic anterior ischemic optic neuropathy (NAION), whether or not this event has been associated with previous exposure to a PDE5 inhibitor.
About this study
Official title: Phosphodiesterase-type 5 Inhibitors in Adult and Adolescent Patients With Univentricular Heart Disease: a Multi-center, Randomized, Double Blind Phase III Study
In univentricular hearts, selective lung vasodilators such as phosphodiesterase type 5 (PDE5) inhibitors would decrease pulmonary resistance and improve exercise tolerance. However, the level of evidence for the use of PDE5 inhibitors in patients with a single ventricle (SV) remains limited. the investigators present the SV-INHIBITION study rationale, design and methods.The SV-INHIBITION trial is a nationwide multicentre, randomised, double blind, placebo-controlled, phase III study, aiming to evaluate the efficacy of sildenafil on the ventilatory efficiency during exercise, in teenagers and adult patients (>15 y.o.) with a SV. Patients with pulmonary arterial hypertension (mean pulmonary arterial pressure (mPAP) > 15 mmHg and trans-pulmonary gradient > 5 mmHg) measured by cardiac catheterisation, will be eligible. The primary outcome is the variation of the VE/VCO2 slope, measured by a cardiopulmonary exercise test, between baseline and 6 months of treatment. A total of 50 patients are required to observe a decrease of 5 ± 5 points in the VE/VCO2 slope, with a power of 90% power and an alpha risk of 5%. The secondary outcomes are: clinical outcomes, 6 minute walk test, SV function, NT Pro BNP, VO2max, stroke volume, mPAP, trans-pulmonary gradient, SF36 quality of life score, safety and acceptability. This study aims to answer the question whether PDE5 inhibitors should be prescribed in patients with a SV. This trial has been built focusing on the 3 levels of research defined by the WHO: disability (exercise tolerance), deficit (SV function), and handicap (quality of life).
Read the detailed description
50 Patients with a single ventricle (e.g. univentricular heart), as defined by the ACC-CHD classification, with a mean pulmonary arterial pressure (mPAP) > 15 mmHg and a trans-pulmonary gradient (TPG) > 5 mmHg, and aged 15 years old and above, will be prospectively recruited in the participating centres during their regular follow-up.
Patients wil be randomised into 2 groups:
- Patients randomised in the group 1 will receive sildenafil in 3 oral doses of 20 mg per day (t.i.d.), as defined in the marketing authorization indicated for PAH in adolescent and adult patients, and for a period of 6 months.
- Patients in the group 2 will receive a placebo (t.i.d.), for the same period of 6 months. To guarantee the double blind, capsules will be similar in size and colour and will be differentiated only by a vial number regarding to the randomization list. The clinical trials unit of the sponsor's pharmacy will centralize treatment allocation and supply to the participating centres. Drug management (reception, storage, delivery and traceability) will be ensured by the pharmacies of the participating centres.
After the 6 month-treatment period, patients will be followed for 3 months, and undergo at least 2 safety visits (1 and 3 months after intervention, and if necessary, any supplementary unscheduled visits). In accordance with the recommendations of the drug notice, the treatment will be suspended progressively over 1 week (20 mg b.i.d for 3 days, then 20 mg q.d. for 4 days, and then stopped) with a reinforcement of the surveillance. Patients will be able to contact an emergency number during this period and the investigator may decide to continue open treatment with sildenafil if clinically justified.
The study will be conducted in compliance with the Good Clinical Practices protocol and Declaration of Helsinki principles. It was approved by a drawn National Ethics Committee (CPP) and by the French National Agency of Medicine and Health Products Safety (ANSM). Informed consent will be obtained from all patients and their parents or legal guardians for minors.
- Being tested
- Sildenafil, Placebos
- Keywords
- Congenital heart defect, single ventricle, Pulmonary hypertension, sildenafil, pulmonary vasodilator, Eexercise capacity
- Medical subject headings
- Univentricular Heart, Hypertension, Pulmonary, Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SildenafilDrug
Also called sildenafil group
Patients randomised in the group 1 will receive sildenafil in 3 oral doses of 20 mg per day
PlacebosDrug
Also called placebo group
Patients randomised in the group placebo in 3 oral doses of per day
| Study group | Role | What they receive |
|---|---|---|
| sildenafil | Experimental | • Patients randomised in the group 1 will receive sildenafil in 3 oral doses of 20 mg per day (t.i.d.), as defined in the marketing authorization indicated for PAH in adolescent and adult patients, and for a period of 6 months. Receives: Drug: Sildenafil |
| placebo | Placebo comparator | • Patients in the group 2 will receive a placebo (t.i.d.), for the same period of 6 months. To guarantee the double blind, capsules will be similar in size and colour and will be differentiated only by a vial number regarding to the randomization list Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
ventilatory efficiency M0
ventilatory efficiency, e.g. the VE/VCO2 slope, measured by CPET
Measured: Month 0
ventilatory efficiency M6
ventilatory efficiency, e.g. the VE/VCO2 slope, measured by
Measured: Month 6
Secondary outcomes (49)
VO2 max M0
maximum oxygen uptake mesured by Cardio-pulmonary exercise test (CPET)
Measured: Month 0
VO2 max M6
maximum oxygen uptake mesured by Cardio-pulmonary exercise test (CPET)
Measured: Month 6
ventilatory anaerobic threshold M0
VAT using Beaver's method
Measured: Month 0
ventilatory anaerobic threshold M6
VAT using Beaver's method
Measured: Month 6
oxygen pulse M0
ratio VO2/heart rate M0
Measured: Month 0
oxygen pulse M6
ratio VO2/heart rate M6
Measured: Month 6
OUES M0
oxygen uptake efficiency slope mesured by CPET
Measured: Month 0
OUES M6
oxygen uptake efficiency slope mesured by CPET
Measured: Month 6
NYHA functional class M0
Functional class from I to IV (New York Heart Association Functional classification).
Measured: Month 0
NYHA functional class M6
Functional class from I to IV (New York Heart Association Functional classification).
Measured: Month 6
blood pressure M0
SV function evaluation with non-invasive imaging
Measured: Month 0
blood pressure M6
function evaluation with non-invasive imaging
Measured: Month 6
oxygen saturation SaO2
oxygen saturation measured using a transcutaneous sensor
Measured: Month 0
oxygen saturation SaO2
oxygen saturation measured using a transcutaneous sensor
Measured: Month 6
6-minute walk test (6MWT)
6-minute walk test
Measured: Month 0
6-minute walk test (6MWT)
6-minute walk test
Measured: Month 6
Health-related quality of life
The SF-36 questionnaire
Measured: Month 0
Health-related quality of life
The SF-36 questionnaire
Measured: Month 6
Systemic blood flow
SV function with echocardiography
Measured: Month 0
Systemic blood flow
SV function with echocardiography
Measured: Month 6
SV systolic ejection fraction
SV function with echocardiography
Measured: Month 0
SV systolic ejection fraction
SV function with echocardiography
Measured: Month 6
2D strain SV function
SV function with echocardiography
Measured: Month 0
2D strain SV function
SV function with echocardiography
Measured: Month 6
Systemic blood flows in phase contrast
SV function evaluation with MRI
Measured: Month 0
Systemic blood flows in phase contrast
SV function evaluation with MRI
Measured: Month 6
Pulmonary blood flows in phase contrast
SV function evaluation with MRI
Measured: Month 0
Pulmonary blood flows in phase contrast
SV function evaluation with MRI
Measured: Month 6
SV systolic ejection fraction
SV function evaluation with MRI
Measured: Month 0
SV systolic ejection fraction
SV function evaluation with MRI
Measured: Month 6
SV systolic ejection volume
SV function evaluation with MRI
Measured: Month 0
SV systolic ejection volume
SV function evaluation with MRI
Measured: Month 6
NT Pro BNP
blood test checked
Measured: Month 0
NT Pro BNP
blood test checked
Measured: Month 6
forced expiratory volume in 1 s (FEV1 )
FEV1 spirometry
Measured: month 0
forced expiratory volume in 1 s (FEV1 )
FEV1 spirometry
Measured: month 6
Forced vital capacity FVC
FVC spirometry
Measured: month 0
Forced vital capacity FVC
FVC spirometry
Measured: month 6
FEV1%
FEV1/FEVC ratio
Measured: month 0
FEV1%
FEV1/FEVC ratio
Measured: month 6
DEMM25/75
DEMM25/75 measured by spirometry
Measured: month 0
DEMM25/75
DEMM25/75 measured by spirometry
Measured: month 6
Capillary lung volume
pulmonary CO/NO transfer (patient seated and lying down)
Measured: month 0
Capillary lung volume
pulmonary CO/NO transfer (patient seated and lying down)
Measured: month 6
Cardiac catheterization
pulmonary arterial pressure mmHg
Measured: month 0
Cardiac catheterization
pulmonary arterial pressure mmHg
Measured: month 6
percentage of patients compliant at 6 months of study treatment
percentage of patients compliant
Measured: month 6
AE
type of Averse events
Measured: month 6
SAE
type of serious Averse events
Measured: month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2019
- Study start1 Jun 2023 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2028 (estimated)
Why it stopped: New sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Single-ventricleStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pascal AMEDRO, MD, PhD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03997097
- Sponsor's protocol ID
- 7574
- Acronym
- VU-INHIB
- Status last verified
- May 2023
- First submitted
- 18 Jun 2019
- Last updated
- 15 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Efficacy of phosphodiesterase type 5 inhibitors in univentricular congenital heart disease: the SVINHIBITION study design Pascal Amedro1,2*, Arthur Gavotto1, Hamouda Abassi1, Marie-Christine Picot3, Stefan Matecki1,2, Sophie Malekzadeh-Milani4, Marilyne Levy4, Magalie Ladouceur5, Caroline Ovaert6,7, Philippe Aldebert6, Jean-Benoit Thambo8, Alain Fraisse9, Marc Humbert10,11, Sarah Cohen11, Alban-Elouen Baruteau12, Clement Karsenty13, Damien Bonnet4, Sebastien Hascoet11 and on behalf of the SV-INHIBITION study investigators ESC Heart Failure (2020) Published online in Wiley Online Library (wileyonlinelibrary.com) DOI: 10.1002/ehf2.12630
Amedro P, Gavotto A, Abassi H, Picot MC, Matecki S, Malekzadeh-Milani S, Levy M, Ladouceur M, Ovaert C, Aldebert P, Thambo JB, Fraisse A, Humbert M, Cohen S, Baruteau AE, Karsenty C, Bonnet D, Hascoet S; SV-INHIBITION study investigators. Efficacy of phosphodiesterase type 5 inhibitors in univentricular congenital heart disease: the SV-INHIBITION study design. ESC Heart Fail. 2020 Apr;7(2):747-756. doi: 10.1002/ehf2.12630. Epub 2020 Mar 9.
PubMed 32147955
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phosphodiesterase-type 5 Inhibitors in Adult and Adolescent Patients With Univentricular Heart Disease: a Multi-center, Randomized, Double Blind Phase III Study
- ClinicalTrials.gov ID
- NCT03997097
- Acronym / sponsor ID
- VU-INHIB / 7574
- Keywords
- Congenital heart defect, single ventricle, Pulmonary hypertension, sildenafil, pulmonary vasodilator, Eexercise capacity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: New sponsor
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 25 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In univentricular hearts, selective lung vasodilators such as phosphodiesterase type 5 (PDE5) inhibitors would decrease pulmonary resistance and improve exercise tolerance. However, the level of evidence for the use of PDE5 inhibitors in patients with a single ventricle (SV) remains limited. the investigators present the SV-INHIBITION study rationale, design and methods.The SV-INHIBITION trial is a nationwide multicentre, randomised, double blind, placebo-controlled, phase III study, aiming to evaluate the efficacy of sildenafil on the ventilatory efficiency during exercise, in teenagers and adult patients (>15 y.o.) with a SV. Patients with pulmonary arterial hypertension (mean pulmonary arterial pressure (mPAP) > 15 mmHg and trans-pulmonary gradient > 5 mmHg) measured by cardiac catheterisation, will be eligible. The primary outcome is the variation of the VE/VCO2 slope, measured by a cardiopulmonary exercise test, between baseline and 6 months of treatment. A total of 50 patients are required to observe a decrease of 5 ± 5 points in the VE/VCO2 slope, with a power of 90% power and an alpha risk of 5%. The secondary outcomes are: clinical outcomes, 6 minute walk test, SV function, NT Pro BNP, VO2max, stroke volume, mPAP, trans-pulmonary gradient, SF36 quality of life score, safety and acceptability. This study aims to answer the question whether PDE5 inhibitors should be prescribed in patients with a SV. This trial has been built focusing on the 3 levels of research defined by the WHO: disability (exercise tolerance), deficit (SV function), and handicap (quality of life).
Detailed description
50 Patients with a single ventricle (e.g. univentricular heart), as defined by the ACC-CHD classification, with a mean pulmonary arterial pressure (mPAP) > 15 mmHg and a trans-pulmonary gradient (TPG) > 5 mmHg, and aged 15 years old and above, will be prospectively recruited in the participating centres during their regular follow-up.
Patients wil be randomised into 2 groups:
- Patients randomised in the group 1 will receive sildenafil in 3 oral doses of 20 mg per day (t.i.d.), as defined in the marketing authorization indicated for PAH in adolescent and adult patients, and for a period of 6 months.
- Patients in the group 2 will receive a placebo (t.i.d.), for the same period of 6 months. To guarantee the double blind, capsules will be similar in size and colour and will be differentiated only by a vial number regarding to the randomization list. The clinical trials unit of the sponsor's pharmacy will centralize treatment allocation and supply to the participating centres. Drug management (reception, storage, delivery and traceability) will be ensured by the pharmacies of the participating centres.
After the 6 month-treatment period, patients will be followed for 3 months, and undergo at least 2 safety visits (1 and 3 months after intervention, and if necessary, any supplementary unscheduled visits). In accordance with the recommendations of the drug notice, the treatment will be suspended progressively over 1 week (20 mg b.i.d for 3 days, then 20 mg q.d. for 4 days, and then stopped) with a reinforcement of the surveillance. Patients will be able to contact an emergency number during this period and the investigator may decide to continue open treatment with sildenafil if clinically justified.
The study will be conducted in compliance with the Good Clinical Practices protocol and Declaration of Helsinki principles. It was approved by a drawn National Ethics Committee (CPP) and by the French National Agency of Medicine and Health Products Safety (ANSM). Informed consent will be obtained from all patients and their parents or legal guardians for minors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sildenafil | Experimental | Drug: Sildenafil• Patients randomised in the group 1 will receive sildenafil in 3 oral doses of 20 mg per day (t.i.d.), as defined in the marketing authorization indicated for PAH in adolescent and adult patients, and for a period of 6 months. |
| placebo | Placebo comparator | Drug: Placebos• Patients in the group 2 will receive a placebo (t.i.d.), for the same period of 6 months. To guarantee the double blind, capsules will be similar in size and colour and will be differentiated only by a vial number regarding to the randomization list |
Who may qualify
- Ages
- 15 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 15 years of age and over.
- Patient's weight over 20 kg
- Patients with CHD with a single ventricular type defined by the classification of congenital heart diseases in Orphanet (53).
- PAH defined by diagnostic catheterization with mean PAP > 15 mmHg and a trans-pulmonary gradient > 5 mmHg, performed as part of the usual follow-up. No definition of PAH in SV is available as a result of a particular physiology. Therefore, we chose the 15mmHg cut-off, which is used in clinical routine to allow or contra-indicate the Fontan procedure [50,51].
- Appropriate written informed consent (adult patients, legal parents for teenagers), and formal assent (teenagers), should to be provided.
Key exclusion criteria (19 listed)
- Patient who is unable to perform a cardio-pulmonary exercise test.
- Cardiac surgery planned during the trial.
- Patient treated by any pulmonary arterial vasodilator drug, as defined in the 2015 PH guidelines (52), within 6 months before inclusion, regardless the duration and the type(s) (oral, intravenous, subcutaneous, inhaled) of administration.
- Patient treated by Sildenafil or any other type of phosphodiesterase-type 5 inhibitor (such as tadalafil) within 6 months before inclusion, regardless the duration of administration.
- Interventional cardiac catheterization planned during the trial (collateral occlusion, fenestration occlusion, stenting, angioplasty, ablation of rhythm disorder), other than during the screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SildenafilAlso: sildenafil groupPatients randomised in the group 1 will receive sildenafil in 3 oral doses of 20 mg per day | Drug | sildenafil |
| PlacebosAlso: placebo groupPatients randomised in the group placebo in 3 oral doses of per day | Drug | placebo |
Primary outcome
ventilatory efficiency M0
Time frame: Month 0
ventilatory efficiency, e.g. the VE/VCO2 slope, measured by CPET
ventilatory efficiency M6
Time frame: Month 6
ventilatory efficiency, e.g. the VE/VCO2 slope, measured by
49 secondary outcomes
VO2 max M0
Time frame: Month 0
VO2 max M6
Time frame: Month 6
ventilatory anaerobic threshold M0
Time frame: Month 0
ventilatory anaerobic threshold M6
Time frame: Month 6
oxygen pulse M0
Time frame: Month 0
oxygen pulse M6
Time frame: Month 6
OUES M0
Time frame: Month 0
OUES M6
Time frame: Month 6
NYHA functional class M0
Time frame: Month 0
NYHA functional class M6
Time frame: Month 6
blood pressure M0
Time frame: Month 0
blood pressure M6
Time frame: Month 6
oxygen saturation SaO2
Time frame: Month 0
oxygen saturation SaO2
Time frame: Month 6
6-minute walk test (6MWT)
Time frame: Month 0
6-minute walk test (6MWT)
Time frame: Month 6
Health-related quality of life
Time frame: Month 0
Health-related quality of life
Time frame: Month 6
Systemic blood flow
Time frame: Month 0
Systemic blood flow
Time frame: Month 6
SV systolic ejection fraction
Time frame: Month 0
SV systolic ejection fraction
Time frame: Month 6
2D strain SV function
Time frame: Month 0
2D strain SV function
Time frame: Month 6
Systemic blood flows in phase contrast
Time frame: Month 0
Systemic blood flows in phase contrast
Time frame: Month 6
Pulmonary blood flows in phase contrast
Time frame: Month 0
Pulmonary blood flows in phase contrast
Time frame: Month 6
SV systolic ejection fraction
Time frame: Month 0
SV systolic ejection fraction
Time frame: Month 6
SV systolic ejection volume
Time frame: Month 0
SV systolic ejection volume
Time frame: Month 6
NT Pro BNP
Time frame: Month 0
NT Pro BNP
Time frame: Month 6
forced expiratory volume in 1 s (FEV1 )
Time frame: month 0
forced expiratory volume in 1 s (FEV1 )
Time frame: month 6
Forced vital capacity FVC
Time frame: month 0
Forced vital capacity FVC
Time frame: month 6
FEV1%
Time frame: month 0
FEV1%
Time frame: month 6
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2023.
- BackgroundEfficacy of phosphodiesterase type 5 inhibitors in univentricular congenital heart disease: the SVINHIBITION study design Pascal Amedro1,2*, Arthur Gavotto1, Hamouda Abassi1, Marie-Christine Picot3, Stefan Matecki1,2, Sophie Malekzadeh-Milani4, Marilyne Levy4, Magalie Ladouceur5, Caroline Ovaert6,7, Philippe Aldebert6, Jean-Benoit Thambo8, Alain Fraisse9, Marc Humbert10,11, Sarah Cohen11, Alban-Elouen Baruteau12, Clement Karsenty13, Damien Bonnet4, Sebastien Hascoet11 and on behalf of the SV-INHIBITION study investigators ESC Heart Failure (2020) Published online in Wiley Online Library (wileyonlinelibrary.com) DOI: 10.1002/ehf2.12630
- Background: PubMed 32147955Amedro P, Gavotto A, Abassi H, Picot MC, Matecki S, Malekzadeh-Milani S, Levy M, Ladouceur M, Ovaert C, Aldebert P, Thambo JB, Fraisse A, Humbert M, Cohen S, Baruteau AE, Karsenty C, Bonnet D, Hascoet S; SV-INHIBITION study investigators. Efficacy of phosphodiesterase type 5 inhibitors in univentricular congenital heart disease: the SV-INHIBITION study design. ESC Heart Fail. 2020 Apr;7(2):747-756. doi: 10.1002/ehf2.12630. Epub 2020 Mar 9.
- Individual participant dataSharing planned: No
Related trials for Single-ventricle
RecruitingObservational study
Long-term Safety Study Following to JRM-001 Treatment in Pediatric Patients With Congenital Heart Disease
Single Ventricle, Hypoplastic Left Heart Syndrome (HLHS)
RecruitingPhase 3
Cardiac Stem/Progenitor Cell Infusion in Univentricular Physiology (APOLLON Trial)
Hypoplastic Left Heart Syndrome, Single Ventricle
Recruiting
Venous Compression in Fontan
Single-ventricle, Fontan Circulation
RecruitingObservational study
PRecision Integrated Saturation Monitor
CHD - Congenital Heart Disease, Single Ventricle Heart Disease
Recruiting
Impact of Early Fortini Initiation on Growth and Interstage Outcomes in Infants With Single Ventricle Physiology
Single-ventricle
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pascal AMEDRO, MD, PhD principal investigator
University Hospital, Montpellier
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sildenafil in people with Single-ventricle and Pulmonary Hypertension, run by University Hospital, Montpellier.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 May 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ventilatory efficiency M0 (time frame: Month 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03997097, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2023; AzTrials last refreshed its copy on 8 Nov 2026.