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Register:	ClinicalTrials.gov
Last refreshed on:	22 May 2023
Main ID:	NCT03997097
Date of registration:	18/06/2019
Prospective Registration:	Yes
Primary sponsor:	University Hospital, Montpellier
Public title:	Efficacy of Phosphodiesterase-type 5 Inhibitors in Patients With Univentricular Congenital Heart Disease VU-INHIB
Scientific title:	Phosphodiesterase-type 5 Inhibitors in Adult and Adolescent Patients With Univentricular Heart Disease: a Multi-center, Randomized, Double Blind Phase III Study
Date of first enrolment:	June 1, 2023
Target sample size:	0
Recruitment status:	Withdrawn
URL:	https://clinicaltrials.gov/show/NCT03997097
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
Phase:	Phase 3

Countries of recruitment

Contacts

Name:	Pascal AMEDRO, MD, PhD
Address:
Telephone:
Email:
Affiliation:	University Hospital, Montpellier

Key inclusion & exclusion criteria

Inclusion Criteria:

1. 15 years of age and over.

2. Patient's weight over 20 kg

3. Patients with CHD with a single ventricular type defined by the classification of
congenital heart diseases in Orphanet (53).

4. 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].

5. Appropriate written informed consent (adult patients, legal parents for teenagers),
and formal assent (teenagers), should to be provided.

6. Beneficiary of a health insurance.

Exclusion Criteria:

1. Patient who is unable to perform a cardio-pulmonary exercise test.

2. Cardiac surgery planned during the trial.

3. 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.

4. 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.

5. Interventional cardiac catheterization planned during the trial (collateral occlusion,
fenestration occlusion, stenting, angioplasty, ablation of rhythm disorder), other
than during the screening.

6. Participation in another clinical trial or administration of an off-label drug in the
4 weeks preceding the screening.

7. Pregnancy, desire for pregnancy, absence of contraception during the study period.

8. Severe hepatic insufficiency (Child-Pugh C class).

9. 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.

10. Combination with products called "nitric oxide donors" (such as amyl nitrite) or with
nitrates in any form, due to the hypotensive effects of nitrates.

11. Concomitant administration of PDE5 inhibitors, such as Sildenafil, with guanylate
cyclase stimulators, such as Riociguat.

12. Combination with the most potent inhibitors of CYP3A4 (eg ketoconazole, itraconazole,
ritonavir).

13. Disposition to priapism, sclerosis of corpora cavernosa, disease of La Peyronie,
sickle cell anemia, multiple myeloma, leukemia.

14. 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.

15. Severe cardiovascular events, recent (<3 months) or not stabilized: myocardial
infarction, unstable angina, sudden cardiac death, ventricular arrhythmia,
cerebrovascular hemorrhage.

16. Active hemorrhagic disorders.

17. Active gastro-duodenal ulcer.

18. 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.

Age minimum: 15 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Single-ventricle

Univentricular Heart

Pulmonary Hypertension

Intervention(s)

Drug: Placebos

Drug: Sildenafil

Primary Outcome(s)

ventilatory efficiency M0 [Time Frame: Month 0]

ventilatory efficiency M6 [Time Frame: Month 6]

Secondary Outcome(s)

2D strain SV function [Time Frame: Month 6]

6-minute walk test (6MWT) [Time Frame: Month 0]

Health-related quality of life [Time Frame: Month 0]

VO2 max M6 [Time Frame: Month 6]

6-minute walk test (6MWT) [Time Frame: Month 6]

NT Pro BNP [Time Frame: Month 0]

Capillary lung volume [Time Frame: month 6]

FEV1% [Time Frame: month 6]

Forced vital capacity FVC [Time Frame: month 0]

NT Pro BNP [Time Frame: Month 6]

oxygen pulse M0 [Time Frame: Month 0]

oxygen pulse M6 [Time Frame: Month 6]

Forced vital capacity FVC [Time Frame: month 6]

Health-related quality of life [Time Frame: Month 6]

SV systolic ejection fraction [Time Frame: Month 6]

VO2 max M0 [Time Frame: Month 0]

2D strain SV function [Time Frame: Month 0]

OUES M6 [Time Frame: Month 6]

SV systolic ejection volume [Time Frame: Month 6]

Systemic blood flows in phase contrast [Time Frame: Month 0]

Systemic blood flows in phase contrast [Time Frame: Month 6]

Cardiac catheterization [Time Frame: month 0]

DEMM25/75 [Time Frame: month 0]

FEV1% [Time Frame: month 0]

OUES M0 [Time Frame: Month 0]

percentage of patients compliant at 6 months of study treatment [Time Frame: month 6]

SAE [Time Frame: month 6]

SV systolic ejection fraction [Time Frame: Month 0]

SV systolic ejection volume [Time Frame: Month 0]

Pulmonary blood flows in phase contrast [Time Frame: Month 6]

AE [Time Frame: month 6]

blood pressure M0 [Time Frame: Month 0]

Capillary lung volume [Time Frame: month 0]

DEMM25/75 [Time Frame: month 6]

oxygen saturation SaO2 [Time Frame: Month 0]

oxygen saturation SaO2 [Time Frame: Month 6]

Systemic blood flow [Time Frame: Month 0]

Systemic blood flow [Time Frame: Month 6]

ventilatory anaerobic threshold M0 [Time Frame: Month 0]

blood pressure M6 [Time Frame: Month 6]

Cardiac catheterization [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]

NYHA functional class M0 [Time Frame: Month 0]

NYHA functional class M6 [Time Frame: Month 6]

ventilatory anaerobic threshold M6 [Time Frame: Month 6]

Pulmonary blood flows in phase contrast [Time Frame: Month 0]

Secondary ID(s)

7574

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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