Sildenafil to Tadalafil in Pulmonary Arterial Hypertension (SITAR)

NCT01043627 | Completed

• 1 other identifier: 09-004590
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 3

Brief Summary

Assess tolerability, transition methods and clinical effects of transition from sildenafil (Revatio) to tadalafil (Adcirca) for treatment of pulmonary arterial hypertension.

Conditions

Pulmonary Arterial Hypertension

Outcome Measures

Primary Outcomes (1)

• Describe tolerability of transition from sildenafil to tadalafil for treatment of pulmonary arterial hypertension (PAH).

  12/2011

Secondary Outcomes (6)

• Compare Treatment Satisfaction Questionnaire for Medication (TSQM) before and 30 days (range 30-45 days) after transition and 3 months (range 12-16 weeks) after transition.

  12/2011

• Compare N-terminal pro-BNP (NBNP) or brain natriuretic peptide (BNP) levels before and 3 months (range 12-16 weeks) after transition.

  12/2011

• Compare 6 minute walk distance before and 3 months (range12-16 weeks) after transition.

  12/2011

• Compare World Health Organization (WHO) functional class before and 3 months (range 12-16 weeks) after transition.

  12/2011

• Compare echo parameters (estimated cardiac output, TAPSE, Tei index) before and 6 months (range 4-8 months) after transition. If sufficient data is available at 3 month followup, this will be compared as well.

  12/2011

Eligibility Criteria

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

Study Population

WHO Group I PAH patients being transitioned from sildenafil to tadalafil therapy.

You may qualify if:

• Treatment for PAH with sildenafil at a dose of 20mg tid or greater for at least 30 days
• Clinical decision to convert from sildenafil to tadalafil therapy
• Patient consents to study participation (for patients who have already transitioned from sildenafil to tadalafil therapy prior to study initiation or identification of the patient, if the patient has provided consent for use of their medical record for research, retrospective review of the transition process will be performed. When possible, these patients will be approached about prospective data collection for the study if the transition occurred less than 3 months prior to consideration of prospective study participation)

You may not qualify if:

• Non-group I PAH
• Age less than 18

Sponsors & Collaborators

• Mayo Clinic: lead
• United Therapeutics: collaborator

Study Sites (3)

Robert Bourge MD

Birmingham, Alabama, 35294, United States

Location

Ron Oudiz

Torrance, California, 90502, United States

Location

Charles Burger MD

Jacksonville, Florida, 32224, United States

Location

Related Publications (1)

• Frantz RP, Durst L, Burger CD, Oudiz RJ, Bourge RC, Franco V, Waxman AB, McDevitt S, Walker S. Conversion from sildenafil to tadalafil: results from the sildenafil to tadalafil in pulmonary arterial hypertension (SITAR) study. J Cardiovasc Pharmacol Ther. 2014 Nov;19(6):550-7. doi: 10.1177/1074248414528066. Epub 2014 Apr 17.

  PMID: 24742768 DERIVED

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Robert P Frantz, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 6, 2010
• First Posted: January 7, 2010
• Study Start: December 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: November 5, 2012

Record last verified: 2012-11

Locations

US (3)