CompletedPhase 3

Mono vs. Dual Therapy for Pediatric Pulmonary Arterial Hypertension

United States28 participantsStarted 2022-08-01

Plain-language summary

The investigators' central hypothesis is that early combination therapy with two PAH-specific oral therapies that have been shown to be well tolerated in the pediatric population, sildenafil and bosentan, will result in better World Health Organization (WHO) functional class at 12 months after initiation of PAH treatment than therapy with sildenafil alone.

Who can participate

Age range3 Months – 18 Years

SexALL

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Inclusion criteria

✓. Diagnosis by cardiac catheterization with in the previous six months: PAH is defined as the presence of mean pulmonary artery pressure \> 25mmHg, pulmonary capillary wedge pressure (or left atrial or left ventricular end diastolic pressure) ≤ 15 mmHg, and pulmonary vascular resistance index (PVRI) \> 3 Woods Units
✓. For infants less than one year of age for whom cardiac catheterization is not considered as part of the clinical team's recommended approach, enrollment will be possible without catheterization if the following four criteria are met:

Exclusion criteria

✕. serum ALT or AST lab value that is \> 2xULN
✕. serum bilirubin lab value that is \> 1.5xULN
✕. creatinine clearance \< 30 mL/min;

What they're measuring

Change in WHO functional class (FC) of Mono vs. Dual Therapy

Timeframe: Baseline, 12 months

Trial details

NCT IDNCT04039464

SponsorJohns Hopkins University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-31

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