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New treatment option for Pulmonary Hypertension
Official title Sildinafil in Pulmonary Hypertension-Rheumatic Chronic Valvular Disease(RCT)
ClinicalTrials.gov ID: NCT07462260
What this study is testing
What is Sildenafil 25 MG?
Sildenafil 25 MG is an investigational medicine, given as an once-daily, being studied as a potential treatment for pulmonary hypertension.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patient with diagnosed rheumatic valvular heart disease
- Age between 18-\> 80 years
- Severe pulmonary hypertension
You likely can't join 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
See the full eligibility criteria
- Patient with diagnosed rheumatic valvular heart disease
- Age between 18-\> 80 years
- Severe pulmonary hypertension
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Hyderābād, Sindh, Pakistan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hyderābād, Sindh, Pakistan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.