A study to compare the effects and safety of 2 drugs in a disease of heart with increased pressures in lung

A randomised placebo-controlled study to compare the safety and efficacy of sildenafil mono therapy with combination therapy of ambrisentan and sildenafil in pulmonary hypertension including eisenmenger syndrome

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/12/010736

Enrollment

Registered

2017-12-04

Start date

Unknown

Completion date

Unknown

Last updated

2025-02-03

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

Conditions

Health Condition 1: null- Eisenmenger syndrome Primary pulmonary hypertension

Interventions

Intervention1: Drug therapy: To compare the efficacy and safety of sildenafil monotherapy versus combination therapy in eisenmenger syndrome and primary PAH Control Intervention1: Placebo versus ambri

Eligibility

Inclusion criteria

Inclusion criteria: Patients with primary pulmonary hypertension and eisenmenger syndrome will be included Without Comorbid hepatic or renal diseases

Exclusion criteria

Exclusion criteria: 1.Secondary causes of pulmonary hypertension 2. Comorbid hepatic and renal conditions 3.Patients with coronary artery disease 4.Patients with contraindications to the drugs

Design outcomes

Primary

Measure	Time frame
Functional class (NYHA) 6 min walk testTimepoint: 6 weeks	—

Secondary

Measure	Time frame
Echocardiography changes in right heart functionTimepoint: 6 weeks	—

Countries

India

Contacts

Public ContactRajesh Vijayvergiya

Postgraduate Institute Of Medical Education and Research

shaadab27@gmail.com8727084695

Outcome results

None listed

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