Effect of Phosphodiesterase-5 Inhibition With Tadalafil on SystEmic Right VEntricular Size and Function

• Register: ClinicalTrials.gov
• Last refreshed on: 3 July 2023
• Main ID: NCT03049540
• Date of registration: 08/02/2017
• Prospective Registration: Yes
• Primary sponsor: Insel Gruppe AG, University Hospital Bern
• Public title: Effect of Phosphodiesterase-5 Inhibition With Tadalafil on SystEmic Right VEntricular Size and Function SERVE
• Scientific title: Effect of Phosphodiesterase-5 Inhibition With Tadalafil on SystEmic Right VEntricular Size and Function - a Multi-center, Double-blind, Randomized, Placebo-controlled Clinical Trial - SERVE Trial
• Date of first enrolment: October 25, 2017
• Target sample size: 100
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03049540
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Austria, Switzerland

Contacts

• Name: Markus Schwerzmann, MD
• Affiliation: Bern University Hospital, Zentrum fuer angeborene Herzfehler

Key inclusion & exclusion criteria

Inclusion Criteria:

Systemic right ventricle due to prior atrial switch operations for complete transposition
of the great arteries (D-TGA) due to congenitally corrected transposition of the great
arteries (ccTGA).

Exclusion Criteria:

- Incapability of giving informed consent

- Myocardial infarction, stroke, or open heart surgery within the 3 months prior to
baseline visit

- Expected heart transplant within the next 6 months starting from baseline

- Pregnant or nursing women (a pregnancy test is mandatory prior to randomization; women
of childbearing potential must agree to use reliable contraception from randomization
to end of study treatment)

- Severe renal insufficiency (Creatinine clearance = 30 ml/min)

- Severe hepatic insufficiency (Child-Pugh-Class C)

- Hypotension with blood pressures < 90/50 mmHg at the baseline visit

- Hypersensibility to Tadalafil

- Allergy to iodinated (in patients undergoing CMDCT) or Gadolinium-based (in patients
undergoing CMR) contrast agents.

- Co-medication with nitrates

- Regular use of "poppers", i.e. alkyl nitrites, that are inhaled for recreational
purposes, including as club drugs used at dance clubs.

- Co-medication with potent CYP3A4 inhibitors: Ketoconazole, Ritonavir, Rifampicin

- Co-medication with other PDE-5 inhibitors for erectile dysfunction during the last
four weeks prior to baseline visit

- Medical history of Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION)

- Hereditary Galactose intolerance, Lactase deficiency or
Glucose-Galactose-Malabsorption

- Participation at another clinical trial in which the primary endpoint has not been
reached.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Heart Defects, Congenital

Transposition of Great Vessels With Ventricular Inversion

Intervention(s)

Drug: Placebo 20 MG

Drug: Tadalafil 20 MG

Primary Outcome(s)

Systemic right ventricle endsystolic volume [Time Frame: 3 years]

Secondary Outcome(s)

Systemic right ventricle ejection fraction [Time Frame: 3 years]

Cardiopulmonary exercise capacity [Time Frame: 3 years]

Serum neurohormonal activation [Time Frame: 3 years]

Secondary ID(s)

V1 2016-10-12

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Swiss National Science Foundation