The Evaluation of Safety and Efficacy of Cyproheptadine in Pulmonary Arterial Hypertensio

Phase 4

• Conditions: primary pulmonary hypertension.; Primary pulmonary hypertension; I27.0

• Registration Number: IRCT20130921014727N7
• Lead Sponsor: Faculty of Pharmacy, Shahid Behesti University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 1 November 2021

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

patients with mean pulmonary arterial pressure (mPAP) =25 mmHg (confirmed by catheterization at diagnosis time) and symptomatic pulmonary arterial hypertension (PAH) diagnosis
functional class (FC) II or III according to the world health organization classification
ages between 18 and 75 years old
6-minute walk test (6-MWT) distance of 50 to 450 m
patients receiving stable treatments for PAH, the phosphodiesterase-5 inhibitors or the endothelin-receptor antagonist (bosentan) or both at a dose, and were being stable clinical and hemodynamical status for at least 3 months before randomization
use of anticoagulants, calcium channel blocker and diuretics will be allowed when the medicine or dosage was unchanged for at least last 3 months

Exclusion Criteria

SSRIs, CCBs, MAOIs, sedatives, hypnotics, and alcohol consumers
patients who sleepiness and drowsiness are associated with hazards in their jobs
pregnancy and lactation
symptomatic prostate hypertrophy
BMI=30
CKD ( SCr.2.5, proteinuria>500mg/d)
COPD
angle-closure glaucoma

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
WHO functional class. Timepoint: At the beginning and 3 months after intervention. Method of measurement: WHO protocol to determine FC.;6-Minute walk test. Timepoint: At the beginning and 3 months after intervention. Method of measurement: the distance which is walked via test by patient.;Mean PAP. Timepoint: At the beginning and 3 months after intervention. Method of measurement: measuring by transthoracic echocardiography.;Blood level of NT-proBNP. Timepoint: At the beginning and 3 months after intervention. Method of measurement: by blood sample.