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A study to assess effects of sildenafil drug in patients of raised blood pressure of lung circulation

Assessment of short term effects of sildenafil therapy in patients with secondary pulmonary hypertension

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/01/007686
Enrollment
122
Registered
2017-01-12
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

Health Condition 1: null- secondary pulmonary hypertension

Interventions

Intervention1: Sildenafil: Sildenafil was given in dose of 20 mg three times a day for 6 week orally. Control Intervention1: Placebo: Placebo was given in controlled arm. Control Intervention2: Placeb

Sponsors

Department of cardiology King george medical university
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients with symptomatic secondary pulmonary hypertension with New York Heart Association (NYHA) functional class II-III with underlying aetiologies of pulmonary hypertension such as valvular heart disease, dilated cardiomyopathy, heart failure with preserved ejection fraction, chronic obstructive pulmonary disease and interstitial lung disease were included in the study.

Exclusion criteria

Exclusion criteria: Patients with primary pulmonary hypertension, hypotension, allergy to sildenafil, ischemic heart disease, on other vasodilators (ex. Nitrate), prior treatment with other anti PAH drugs, prior cardiac valve surgery, severe valve stenosis were excluded from the study.

Design outcomes

Primary

MeasureTime frame
Clinical improvement (improvement in 6 minute walk test, and NYHA functional class)Timepoint: at the end of 6 week

Secondary

MeasureTime frame
(i) the change from baseline to week 6 in haemodynamic and biochemical parameters PASP, LVEF, RV function, and NT-Pro BNP level; (ii) safety and tolerability.Timepoint: at the end of 6 week

Countries

India

Contacts

Public ContactPrashant Dwivedi

king georges medical university

vnarain@yahoo.com9415022680

Outcome results

None listed

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