Phosphodiesterase-5 Inhibitor in Eisenmenger Syndrome

NCT01200732 | Completed Phase 2

• 1 other identifier: ES/F.501(134)/EC/07/MC
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

A preliminary observational study by the investigators has shown that tadalafil, a selective phosphodiesterase-5 inhibitor (PDE-5) decreases pulmonary vascular resistance(PVR) in patients of eisenmenger syndrome (ES) resulting in increase in pulmonary blood flow (Qp), systemic oxygen saturation (SaO2), functional class and exercise capacity. The aim of this placebo controlled trial was to assess the effect of the drug on exercise capacity and functional class compared to placebo.

Conditions

Eisenmenger Syndrome

Keywords

Tadalafil; phosphodiesterase-5 inhibitor; Eisenmenger syndrome

Outcome Measures

Primary Outcomes (1)

• The primary end point of efficacy was improvement in exercise tolerance as assessed by the un-encouraged 6 minute walk test (6MWT) compared to baseline after 6 weeks of treatment

  6 weeks

Secondary Outcomes (5)

• The secondary endpoints were effect of the drug on systemic oxygen saturation (SaO2)

  6 weeks

• The secondary endpoints were effect of the drug on effective pulmonary blood flow(EPBF)

  6 weeks

• The secondary endpoints were effect of the drug on pulmonary vascular resistance (PVR).

  6 weeks

• The secondary endpoints were effect of the drug on systemic vascular resistance (SVR)

  6 weeks

• The secondary endpoints were effect of the drug on WHO functional class

  6 weeks

Study Arms (2)

Tadalafil

ACTIVE COMPARATOR

Drug: Tadalafil, placebo

placebo

PLACEBO COMPARATOR

Drug: Tadalafil, placebo

Interventions

Tadalafil, placebo DRUG

20mg tablets, 2 tablets Once daily(i.e 40mg once daily) 20mg placebo 2 tablets once daily

Tadalafil; placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of ES with age greater than or equal to 14 years and weight greater than or equal to 30 kgs in World Health Organisation (WHO) functional class II and III attending our congenital clinic were invited to participate in the study

You may not qualify if:

• WHO class IV,
• congestive heart failure or had PCWP \> 15mmHg,
• left ventricular ejection fraction \<40%,
• atrial fibrillation,
• patent ductus arteriosus,
• complex congenital heart defects,
• restrictive lung disease(total lung capacity \< 70% of predicted), obstructive lung disease ( forced expiratory volume in 1 second \[FEV1\] \< 70% of predicted with FEV1/ Forced vital capacity \[FVC\] \< 60%),
• previously diagnosed coronary artery disease requiring nitrate therapy,
• abnormal biochemical profile and
• hypersensitivity to PDE- 5 inhibitors.

Sponsors & Collaborators

• Govind Ballabh Pant Hospital: lead

Study Sites (1)

Govind Ballabh Pant Hospital(GB Pant Hospital)

New Delhi, New Delhi, 110002, India

Location

Related Publications (2)

• Mukhopadhyay S, Sharma M, Ramakrishnan S, Yusuf J, Gupta MD, Bhamri N, Trehan V, Tyagi S. Phosphodiesterase-5 inhibitor in Eisenmenger syndrome: a preliminary observational study. Circulation. 2006 Oct 24;114(17):1807-10. doi: 10.1161/CIRCULATIONAHA.105.603001. Epub 2006 Oct 9.

  PMID: 17030688 BACKGROUND

• Mukhopadhyay S, Nathani S, Yusuf J, Shrimal D, Tyagi S. Clinical efficacy of phosphodiesterase-5 inhibitor tadalafil in Eisenmenger syndrome--a randomized, placebo-controlled, double-blind crossover study. Congenit Heart Dis. 2011 Sep-Oct;6(5):424-31. doi: 10.1111/j.1747-0803.2011.00561.x.

  PMID: 21914136 DERIVED

MeSH Terms

Conditions

Eisenmenger Complex

Interventions

Tadalafil

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Carbolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Officials

• Saibal Mukhopadhyay, M.D;D.M

  GBPant Hospital

  PRINCIPAL INVESTIGATOR

• Sanjay Tyagi, M.D;D.M

  GBPant Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: September 8, 2010
• First Posted: September 14, 2010
• Study Start: February 1, 2008
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: September 14, 2010

Record last verified: 2010-08

Locations

IN (1)