Sildinafil in Pulmonary Hypertension-Rheumatic Chronic Valvular Disease(RCT)

NCT07462260 | Recruiting Phase 2 DMC

• 1 other identifier: ERC-44/2022
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Pulmonary hypertension secondary to left heart disease is associated with increased morbidity and mortality, particularly in patients with rheumatic chronic valvular heart disease, which remains highly prevalent in low- and middle-income countries. These patients often present late with severe pulmonary hypertension, limiting surgical options and worsening outcomes. Sildenafil, a phosphodiesterase-5 inhibitor, has demonstrated benefit in various forms of pulmonary hypertension; however, its role in pulmonary hypertension secondary to rheumatic valvular disease remains inadequately studied. This double-blind, placebo-controlled randomized clinical trial aims to evaluate the efficacy and safety of sildenafil as an adjunct to standard medical therapy in patients with severe pulmonary hypertension due to rheumatic chronic valvular heart disease. Eligible participants will be randomized in a 1:1 ratio to receive either sildenafil (25 mg three times daily) or placebo for six weeks. The primary outcome is change in six-minute walk distance, while secondary outcomes include changes in right ventricular function and dimensions, systolic pulmonary artery pressure, NYHA functional class, and hospitalization rates. The study seeks to generate evidence to support medical optimization and bridging therapy in this high-risk population awaiting definitive surgical intervention.

Conditions

Pulmonary Hypertension; Rheumatic Valvular Heart Disease

Keywords

Six minutes walk

Outcome Measures

Primary Outcomes (1)

• Change in 6-Minute Walk Distance (6MWD)

  Change in distance walked during the 6-minute walk test from baseline to 6 weeks after randomization.

  Baseline to 6 weeks

Secondary Outcomes (5)

• Change in Right Ventricular Function Description:

  Baseline to 6 weeks

• Change in Right Ventricular Dimensions

  Baseline to 6 weeks

• Change in Systolic Pulmonary Artery Pressure

  Baseline to 6 weeks

• Change in New York Heart Association (NYHA) Functional Class

  Baseline to 6 weeks

• Number of Hospitalizations

  Up to 6 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

Participants receive oral sildenafil 25 mg three times daily for 6 weeks in addition to standard guideline-directed medical therapy for rheumatic chronic valvular heart disease and associated conditions.

Drug: Sildenafil 25 MG

Placebo Group

PLACEBO COMPARATOR

Participants receive matching placebo three times daily for 6 weeks in addition to standard guideline-directed medical therapy.

Drug: Placebo

Interventions

Sildenafil 25 MG DRUG

Thrice a day

Intervention group

Placebo DRUG

Thrice a day

Placebo Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with diagnosed rheumatic valvular heart disease
• Age between 18-\> 80 years
• Severe pulmonary hypertension

You may not qualify if:

• Patient undergoing corrective surgery within 6 weeks
• Uncontrolled hypertension (\>170/110mmHg)
• Hypotension (Blood pressure of \< 90/50mmHg)
• Heart Failure or Coronary Arterial Diseases with Unstable Angina
• Hypersensitivity to sildenafil or any component of the formulation of sildenafil
• Prior episode of non-arteritic anterior ischemic neuropathy
• Stroke in last 6 months
• Life-threatening arrhythmias
• MI in last 6 months
• Patient takes nitrates as essential drug therapy
• Patient doesn't have a plan for corrective surgery within 6 weeks

Sponsors & Collaborators

• Sindh Institute of Cardiovascular Diseases: lead
• National Institute of Cardiovascular Diseases: collaborator

Study Sites (1)

Sindh Institute of Cardiovascular Diseases

Hyderābād, Sindh, Pakistan

RECRUITING

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Dr Jawaid Akbar Sial

  Sindh Institute of Cardiovascular Diseases

  STUDY DIRECTOR

Central Study Contacts

Dr Aamir Khuwaja

CONTACT

03323594539; khuwaja.aamir91@gmail.com

Dr Raheela Khowaja

CONTACT

03312273977; drraheela.allahbux@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This study is double-blinded. Participants, treating physicians, investigators, and outcome assessors are blinded to treatment allocation. Sildenafil and placebo are identical in appearance and administration. Randomization is performed using a concealed electronic system, and treatment codes are not disclosed until completion of data analysis or in the event of a medical emergency requiring unblinding.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Cardiac Surgery SICVD

Model Details: Participants are randomized into two groups (sildenafil + standard therapy vs placebo + standard therapy) and followed simultaneously, with no crossover. Allocation: Randomized Intervention Model Description (optional one-liner) Masking: Double (Participant, Investigator, Outcomes Assessor) Primary Purpose: Treatment

Study Record Dates

• First Submitted: March 5, 2026
• First Posted: March 10, 2026
• Study Start: August 1, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 10, 2026

Record last verified: 2026-03

Locations

PA (1)