Serotonin Transporter Inhibitor Escitalopram in Pulmonary Hypertension

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00190333
• Date of registration: 13/09/2005
• Prospective Registration: No
• Primary sponsor: Assistance Publique - Hôpitaux de Paris
• Public title: Serotonin Transporter Inhibitor Escitalopram in Pulmonary Hypertension
• Scientific title: Evaluation of the Therapeutic Effects of Escitalopram in Pulmonary Hypertension, Either Primary or Associated
• Date of first enrolment: June 2005
• Target sample size: 30
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00190333
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

France

Contacts

• Name: Gerald SIMONNEAU, MD
• Affiliation: Assistance Publique - Hôpitaux de Paris

Key inclusion & exclusion criteria

Inclusion Criteria:

Subjects who meet all the criteria listed below will be considered for study inclusion:

- Male or female older than 18 years of age

- Meeting World Health Organization (WHO) criteria for pulmonary hypertension (mean
pulmonary arterial pressure [PAP] > 25 mmHg at rest and pulmonary capillary wedge
pressure < 15 mmHg during right heart catheterization):

- primary pulmonary hypertension (sporadic or familial), or

- pulmonary hypertension associated with connective tissue diseases, or

- pulmonary hypertension associated with HIV infection, or

- pulmonary hypertension associated with use of appetite suppressants or other
toxic compounds, or

- pulmonary hypertension associated with shunting through a congenital heart
defect surgically treated

- Class II or III in the NYHA classification scheme

- With a 6-minute walking test distance between 40% and 80% of theoretical values
(approximately 50 and 480 m)

- On conventional treatment, with no change in this treatment during the last month
preceding the study. Conventional treatment includes calcium antagonists or
beraprost.

- Subject who consents to participate in the study.

Exclusion Criteria:

Subjects with any of the following clinical features will not be included in the study:

- Pulmonary hypertension related to aortic or mitral valve disease, or extrinsic
pulmonary vein compression

- Pulmonary hypertension related to hypoxia from respiratory disease with a total lung
capacity < 70% or Tiffeneau index < 60% upon testing within the last 6 months
(chronic obstructive lung disease, interstitial disease, sleep apnea syndrome,
alveolar hypoventilation, chronic exposure to high altitudes, neonatal lung disease,
or alveolar capillary dysplasia)

- Pulmonary hypertension associated with portal hypertension

- Pulmonary hypertension secondary to chronic thrombosis and/or embolism (occlusion of
the proximal or distal pulmonary arteries by thrombosis)

- In the 6-minute walking test, inability to walk for 6 minutes, for any reason, or
walking distance of less than 50 m

- Pregnancy, lactation, women of childbearing potential (if needed, effective
contraception will be prescribed)

- History of hypersensitivity to citalopram or to medications structurally related to
citalopram

- Treatment with another investigational drug within the 3 months preceding study
inclusion

- Cardiovascular, hepatic, neurological or endocrine disease that is clinically
significant, or any other significant disease that may interfere with the study
protocol or with the interpretation of study findings

- History of drug or alcohol abuse

- Liver failure (except abnormalities related to the right ventricular failure)

- Kidney failure

- Mental status preventing the patient from understanding the nature, objectives, and
possible consequences of the study

- Non stabilized psychiatric disorders

- Subject unable to comply with protocol-related constraints (e.g., uncooperative,
unable to attend follow-up visits, and probably unable to complete the study).



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

Health Condition(s) or Problem(s) studied

Pulmonary Hypertension

Intervention(s)

Drug: escitalopram

Primary Outcome(s)

To evaluate the efficacy of oral escitalopram at the dosage of 30 mg/day on the 6-minute walking test in patients with pulmonary hypertension [Time Frame: for 16 weeks]

Secondary Outcome(s)

To evaluate the efficacy of escitalopram in improving the quality of life [Time Frame: after 16 weeks]

To evaluate the efficacy of escitalopram in improving the New York Heart Association (NYHA) class [Time Frame: after 16 weeks]

To evaluate the efficacy of escitalopram in reducing exacerbations of signs or symptoms of the disease that would otherwise require hospital admission or treatment intensification, particularly treatment with bosentan or IV administration of epoprostenol [Time Frame: after 16 weeks]

To evaluate the safety of escitalopram, alone or on top of associated drugs [Time Frame: after 16 weeks]

To evaluate the efficacy of escitalopram in improving hemodynamic parameters (right heart catheterization; decision of doing right heart catheterization belonging to the investigators) [Time Frame: after 16 weeks]

To evaluate the efficacy of escitalopram in improving the dyspnea (visual analog scale) [Time Frame: after 16 weeks]

Secondary ID(s)

P020305

Source(s) of Monetary Support

Please refer to primary and secondary sponsors