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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03528902
Other study ID # 180241
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date October 1, 2018
Est. completion date June 14, 2023

Study information

Verified date July 2023
Source Vanderbilt University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The main purpose of this clinical trial is to examine the feasibility and effects of tamoxifen in subjects with pulmonary arterial hypertension (PAH). The study will evaluate how well the drug is tolerated, and its impact on functional condition and selected biomarkers. Changes in tricuspid annular plane systolic excursion (TAPSE) and other parameters determined by transthoracic echocardiography will be evaluated as well as changes in additional metrics such as six minute walk test distance, quality of life assessments, and hormone levels.


Description:

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Study Design


Intervention

Drug:
Tamoxifen
Tamoxifen 20 mg po daily for 24 weeks.
Placebo Oral Tablet
Placebo

Locations

Country Name City State
United States Vanderbilt University Medical Center Nashville Tennessee

Sponsors (1)

Lead Sponsor Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Plasma BNP Change in Plasma BNP levels will be assessed from Week 0 to Week 24 during the study. These measurements are made from the plasma, and will require a blood draw from the research participant. 24 weeks
Other HgbA1c Change in hemoglobin A1c (HgbA1c) levels will be assessed from Week 0 to Week 24 during the study. These measurements are made from the plasma, and will require a blood draw from the research participant. 24 weeks
Primary Transthoracic echocardiogram (ECHO)-based change in the Tricuspid Annular Plane Systolic Excursion (TAPSE) measurement Transthoracic echocardiograms (ECHOs) will be performed to measure the TAPSE value prior to Intervention at Week 0, as well as at the end of the study intervention (Week 24). The primary outcome measure will be the change in TAPSE, determined by echocardiogram, from Week 0 to Week 24.
About TAPSE: Tricuspid annular plane systolic excursion (TAPSE) is a parameter of global right ventricular function which describes apex-to-base shortening of the ventricle. It is obtained by transthoracic echocardiogram, which can be performed on a resting subject without sedation in the outpatient setting. TAPSE correlates closely with the right ventricular ejection fraction, and has been determined to be both highly specific and easy to measure.
24 weeks
Secondary Six minute walk test distance (6MWTD) Change in 6MWTD from Week 0 to Week 24. The 6-minute walk test distance (6MWTD) is a widely accepted measure of exercise capacity and functional status. The 6MWTD is a clinical and research test obtained in a standardized manner according to American Thoracic Society (ATS) Guidelines.
Briefly, the 6MWT is a sub-maximal exercise test on flat ground that is used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity over time.
24 weeks
Secondary Quality of life will be assessed using the SF36 questionnaire. This will be administered at baseline and 12 and 24 weeks. Change in score from Week 0 to Week 24.
Specifically, Quality of life will be assessed using two different accepted questionnaires for pulmonary hypertension patients, the SF36 and emPHasis-10 questionnaires. These will be administered at baseline and 12 and 24 weeks.
24 weeks
Secondary Quality of life will be assessed using emPHasis-10 questionnaire. This will be administered at baseline and 12 and 24 weeks. Change in score from Week 0 to Week 24. 24 weeks
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