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The effectiveness of spironolactone in group 1 pulmonary hypertension patients

A clinical trial to compare the effectiveness of spironolactone with the standard treatment in right ventricular function in group 1 pulmonary hypertension patients

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20171120037376N1
Enrollment
50
Registered
2017-11-20
Start date
2017-12-22
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Group 1 pulmonary hypertension. Other specified pulmonary heart diseases

Interventions

Intervention 1: Control group: Who will receive 10-20 mg of tadalafil and 125 mg of bosentan once or twice a day for four months. Intervention 2: Intervention group: Who will receive 10-20 mg of tadal
Treatment - Drugs
Control group: Who will receive 10-20 mg of tadalafil and 125 mg of bosentan once or twice a day for four months.
Intervention group: Who will receive 10-20 mg of tadalafil and 125 mg of bosentan once or twice a day in addition to 25 mg of spironolactone in addition to the standard treatment on a daily basis for

Sponsors

Vice Chancellor for Research, Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
12 Years to 76 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Patients with group 1 pulmonary hypertension; aged between 12 and 76 years. Exclusion criteria: Eisenmenger's syndrome; congenital diseases; scleroderma, thalassemia, systemic disease, cirrhosis, cor pulmonale, renal failure; frequent readmission and receiving inotropic therapy; left systolic dysfunction; mental disabilities; pulmonary disease of asthma; and unwillingness to follow up.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Systolic and diastolic function of the right ventricle. Timepoint: Before and four months after treatment. Method of measurement: Echo.;Clinical signs (blood pressure, heart rate, and oxygen saturation). Timepoint: Before and four months after treatment. Method of measurement: 6MWD test.

Secondary

MeasureTime frame
Serum NT-ProBNP levels. Timepoint: Before and four months after treatment. Method of measurement: ELISA.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactEghane Mobaser

Mashhad University of Medical Sciences

mobsery931@mums.ac.ir+98 51 3854 3031

Outcome results

None listed

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