A study to compare the effects and safety of 2 drugs in a disease of heart with increased pressures in lung
- Conditions
- Eisenmenger syndrome Primary pulmonary hypertension
- Registration Number
- CTRI/2017/12/010736
- Lead Sponsor
- PGIMER Chandigarh
- Brief Summary
This is a prospective randomised placebo controlled double blind study to assess the efficacy and safety of sildenafil and ambrisentan combination therapy versus mono therapy with sildenafil. 20 patients with primary pulmonary hypertension or eisenmenger syndrome will be included and randomised to receive either sildenafil with ambrisentan or sildenafil and placebo. They will be followed up for 6 weeks. Their baseline functional status and echocardiographic findings will be recorded and assessed at 6 week follow up. Any adverse effect will also be recorded and reported. This study has been given ethical clearance from the institute ethics committee PGIMER CHANDIGARH. This study is intended to be a part of postgraduate thesis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 20
Patients with primary pulmonary hypertension and eisenmenger syndrome will be included Without Comorbid hepatic or renal diseases.
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Functional class (NYHA) 6 weeks 6 min walk test 6 weeks
- Secondary Outcome Measures
Name Time Method Echocardiography changes in right heart function 6 weeks
Trial Locations
- Locations (1)
Postgraduate Institute of Medical education and research
🇮🇳Chandigarh, CHANDIGARH, India
Postgraduate Institute of Medical education and research🇮🇳Chandigarh, CHANDIGARH, IndiaRajesh VijayvergiyaPrincipal investigator7087009513rajeshvijay999@hotmail.com