Serotonin Transporter Inhibitor Escitalopram in Pulmonary Hypertension
Information source: Assistance Publique - Hôpitaux de Paris
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pulmonary Hypertension
Intervention: escitalopram (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Assistance Publique - Hôpitaux de Paris Official(s) and/or principal investigator(s):
Gerald SIMONNEAU, MD, Study Chair, Affiliation: Assistance Publique - Hôpitaux de Paris
Overall contact:
Gerald SIMONNEAU, MD, Phone: +33(0)-1 45 37 47 76, Email: gerald.simonneau@abc.aphp.fr
Summary
This is a Phase III, multicenter, randomized, double-blind, placebo-controlled study to
evaluate the efficacy of escitalopram (30 mg/day) in two parallel groups (randomization
ratio, escitalopram 2/placebo 1).
Clinical Details
Official title: Evaluation of the Therapeutic Effects of Escitalopram in Pulmonary Hypertension, Either Primary or Associated
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: 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
Secondary outcome: To evaluate the efficacy of escitalopram in improving hemodynamic parameters (right heart catheterization; decision of doing right heart catheterization belonging to the investigators)To evaluate the efficacy of escitalopram in improving the New York Heart Association (NYHA) class To evaluate the efficacy of escitalopram in improving the dyspnea (visual analog scale) To evaluate the efficacy of escitalopram in improving the quality of life 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 To evaluate the safety of escitalopram, alone or on top of associated drugs
Detailed description:
Primary objective: to evaluate the efficacy of oral escitalopram at the dosage of 30 mg/day
for 16 weeks on the 6-minute walking test in patients with pulmonary hypertension.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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).
Locations and Contacts
Gerald SIMONNEAU, MD, Phone: +33(0)-1 45 37 47 76, Email: gerald.simonneau@abc.aphp.fr
Henri Mondor Hospital, CRETEIL 94010, France; Not yet recruiting
Serge ADNOT, MD, Phone: +33(0)-1 49 81 36 83, Email: serge.adnot@hmn.aphp.fr
Serge ADNOT, MD, Principal Investigator
Antoine Beclere Hospital, CLAMART 92140, France; Recruiting
Gerald SIMONNEAU, MD, Phone: +33(0)-1 45 37 47 76, Email: gerald.simonneau@abc.aphp.fr
Gerald SIMONNEAU, MD, Principal Investigator
Hautepierre Hospital, STRASBOURG 67200, France; Not yet recruiting
Ari CHAOUAT, MD, Email: ari.chaouat@chru-strasbourg.fr
Ari CHAOUAT, MD, Principal Investigator
Brabois Hospital, Vandoeuvre les Nancy 54500, France; Not yet recruiting
François CHABOT, MD, Email: f.chabot@chu-nancy.fr
François CHABOT, MD, Principal Investigator
Rangueil Hospital, Toulouse 31059, France; Recruiting
Bruno DEGANO, MD, Phone: +33(0)-5 67 77 17 40, Email: degano.b@chu-toulouse.fr
Bruno DEGANO, MD, Principal Investigator
Haut Lévèque Hospital, Pessac 33604, France; Not yet recruiting
Claire DROMER, MD, Phone: +33(0)-5 57 65 60 09, Email: claire.dromer@chu-bordeaux.fr
Claire DROMER, MD, Principal Investigator
Louis Pradel Hospital, BRON 69677, France; Recruiting
Vincent COTTIN, MD, Phone: +33(0)-4 72 35 70 72, Email: vincent.cottin@chu-lyon.fr
Vincent COTTIN, MD, Principal Investigator
Michallon Hospital, GRENOBLE 38043, France; Not yet recruiting
Christophe PISON, MD, Phone: +33(0)-4 76 76 58 34, Email: c.pison@chu-grenoble.fr
Christophe PISON, MD, Principal Investigator
Sainte Marguerite Hospital, Marseille 13009, France; Not yet recruiting
Martine REYNAUD-GAUBERT, MD, Email: martine.reynaud@ap-hm.fr
Martine REYNAUD-GAUBERT, MD, Principal Investigator
Additional Information
Starting date: June 2005
Ending date: June 2009
Last updated: November 14, 2007
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