The Pilot Study of Efficacy and Safety of Cyproheptadine in Pulmonary Arterial Hypertension Patients in Massih Daneshvari Hospital

Evaluation of efficacy and safety of cyproheptadine in patients with pulmonary artery hypertension

This is a 12 weeks pilot study, double-blind, placebo-controlled, parallel-group, phase II, randomized trial with 12 patients

patients who have inclusion criteria will receive cyproheptadine 4 mg/daily for 3 months. patients will evaluate before and after the intervention

Inclusion criteria: patients with mean pulmonary arterial pressure ≥25 mmHg (confirmed by catheterization at diagnosis time) and symptomatic pulmonary arterial hypertension diagnosis, functional class II or III according to the world health organization classification, ages between 18 and 75 years old, 6-minute walk test 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 having a stable clinical and hemodynamical status for at least 3 months, and use of anticoagulants, calcium channel blocker, and diuretics will be allowed when the medicine or dosage has been unchanged for at least the last 3 months. Exclusion criteria: patients taking narcotics, sedatives, alcohol, hypnotics, monoamine inhibitors (MAOIs), and selective serotonin reuptake inhibitors, angle-closure glaucoma, symptomatic benign prostate hyperplasia, pregnancy and lactation, chronic kidney disease, occupations in which sleepiness is associated with hazards, and BMI≥30 kg/m2.

interventional groups include intervention group (cyproheptadine) and control group (placebo)

6-MW distance, mean-PAP, NT-ProBNP, and FC

Shahid Beheshti University of Medical Sciences, research deputy

in this study we will use unrestricted or simple randomization. the study utilizes individual sampling. we are using a random number table to randomize patients. patients in our center are numbered and even numbers are allocated to the drug group and odd numbers are allocated to the placebo group. numbers on the table select from the top left corner and the direction is toward the bottom right corner. every patient will receive a can containing pills. each pill can is labeled with a specific number that indicates drug or placebo. the numbers' information will have been hidden from patients and researchers by the time of analysis.

Each drug label has a number which indicates that the patient using the drug or the placebo. list of numbers are keeping hidden from patients and research team.