A clinical trial to study the effects of Tadalafil in patients with pulmonary hypertension.

The efficacy and safety of PDE-5 inhibitor Tadalafil in patients of Pulmonary Hypertension

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000744

Enrollment

Registered

2010-07-01

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

None listed

Interventions

Intervention1: Tatalafil: 20 mg OD Control Intervention1: NIL: NIL

Eligibility

Inclusion criteria

Inclusion criteria: symptomatic patients >= 18 year of age with WHO Group I PAH -Associated PAH: congenital L -->R shunt

Exclusion criteria

Exclusion criteria: Contraindication for Tadalafil or PDE-5 inhibitors, Other WHO PAH Group (II, III, IV, V), Patient not able to give informed consent, Participation in another PAH trial or other trial (current or within one month of completion), Patients with neuromuscular or orthopedic condition not permitting active participation, with other medical illness limiting life expectancy < 6 months.

Design outcomes

Primary

Measure	Time frame
6 minute walk testTimepoint: baseline,1 month and 3monthly till 36 months.;Quality of life (EQ-5D)Timepoint: baseline,1 month and 3monthly till 36 months.;WHO Functional ClassTimepoint: baseline,1 month and 3monthly till 36 months.	—

Secondary

Measure	Time frame
Composite of 6MWD/WHO functional class/ EQ-5DTimepoint: at the end of 3 months, 12 months, 24 months and 36 months.;Event free survival at end of 36 months. This includes freedom from all cause deaths,PAH related hospitalization,need for addition of another PAH specific therapies or atrial septostomy or heart/lung transplantation.Timepoint: at the end of 3 months, 12 months, 24 months and 36 months.	—

Measure

Time frame

Composite of 6MWD/WHO functional class/ EQ-5DTimepoint: at the end of 3 months, 12 months, 24 months and 36 months.;Event free survival at end of 36 months. This includes freedom from all cause deaths,PAH related hospitalization,need for addition of another PAH specific therapies or atrial septostomy or heart/lung transplantation.Timepoint: at the end of 3 months, 12 months, 24 months and 36 months.

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Countries

India

Contacts

Public ContactDr. Ashish Patel

M.G.M.Medical College and M.Y.Hospital ,Indore,India

anilbharani@gmail.com0731- 2491214

Outcome results