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Serotonin Transporter Inhibitor Escitalopram in Pulmonary Hypertension

Primary Purpose

Pulmonary Hypertension

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
escitalopram
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Hypertension focused on measuring pulmonary hypertension, 6 minutes walking test, serotonin, primary or associated pulmonary hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Louis Pradel Hospital
  • Antoine Beclere Hospital
  • Henri Mondor Hospital
  • Michallon Hospital
  • Sainte Marguerite Hospital
  • Haut Lévèque Hospital
  • Hautepierre Hospital
  • Rangueil Hospital
  • Brabois Hospital

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

A

Arm Description

Outcomes

Primary Outcome Measures

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 Measures

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

Full Information

First Posted
September 13, 2005
Last Updated
February 17, 2011
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT00190333
Brief Title
Serotonin Transporter Inhibitor Escitalopram in Pulmonary Hypertension
Official Title
Evaluation of the Therapeutic Effects of Escitalopram in Pulmonary Hypertension, Either Primary or Associated
Study Type
Interventional

2. Study Status

Record Verification Date
March 2007
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Hypertension
Keywords
pulmonary hypertension, 6 minutes walking test, serotonin, primary or associated pulmonary hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
escitalopram
Intervention Description
escitalopram
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
To evaluate the efficacy of escitalopram in improving the New York Heart Association (NYHA) class
Time Frame
after 16 weeks
Title
To evaluate the efficacy of escitalopram in improving the dyspnea (visual analog scale)
Time Frame
after 16 weeks
Title
To evaluate the efficacy of escitalopram in improving the quality of life
Time Frame
after 16 weeks
Title
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
Title
To evaluate the safety of escitalopram, alone or on top of associated drugs
Time Frame
after 16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerald SIMONNEAU, MD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Study Chair
Facility Information:
Facility Name
Louis Pradel Hospital
City
Bron
ZIP/Postal Code
69677
Country
France
Facility Name
Antoine Beclere Hospital
City
Clamart
ZIP/Postal Code
92140
Country
France
Facility Name
Henri Mondor Hospital
City
Creteil
ZIP/Postal Code
94010
Country
France
Facility Name
Michallon Hospital
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Sainte Marguerite Hospital
City
Marseille
ZIP/Postal Code
13009
Country
France
Facility Name
Haut Lévèque Hospital
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
Hautepierre Hospital
City
Strasbourg
ZIP/Postal Code
67200
Country
France
Facility Name
Rangueil Hospital
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Brabois Hospital
City
Vandoeuvre les Nancy
ZIP/Postal Code
54500
Country
France

12. IPD Sharing Statement

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Serotonin Transporter Inhibitor Escitalopram in Pulmonary Hypertension

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