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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

IRCT

Registry ID

IRCT20130921014727N7

Enrollment

Registered

2021-09-23

Start date

2015-01-20

Completion date

Unknown

Last updated

2021-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

primary pulmonary hypertension. Primary pulmonary hypertension

Interventions

Intervention 1: for intervention group: cyproheptadine 4mg PO q12hr for 3 monthes. Intervention 2: for control group: identical placebo tablet q12hr PO for 3 monthes.

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactShahab Moradi Haghighat

Faculty of Pharmacy, Shahid Behesti University of Medical Sciences

sh.moradi91@outlook.com+98 21 6657 3278

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026