Phase 2 Pulmonary Hypertension Trial, Recruiting NCT05201144 Sponsor: University of Utah Condition: Pulmonary Hypertension
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Phase 2 Pulmonary Hypertension Trial, Recruiting

NCT05201144
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • The baby must be a newborn admitted to the Phoenix Children's Hospital NICU (Neonatal Intensive Care Unit)
  • The baby must have been diagnosed with congenital diaphragmatic hernia (CDH), which is a condition where there is a hole in the diaphragm (the muscle separating the chest and belly) that allows organs to move into the chest
  • The baby must have already had surgery to repair this hole in the diaphragm
  • The baby must have had a heart ultrasound (echocardiogram) done 48–72 hours after surgery showing a specific measurement (called LVEI) of 1.4 or higher, which indicates the heart is under strain (confirm with trial site)
  • A parent or guardian must give their consent to participate within 24 hours of that heart ultrasound

Who may not be able to join:

  • Babies with CDH who did not have surgery to repair the diaphragm
  • Babies who did not have a heart ultrasound done 48–72 hours after their surgery
  • Babies whose heart ultrasound showed an LVEI measurement below 1.4
  • Babies who also have a serious heart defect that requires its own heart surgery as a newborn
  • Babies who are known to be allergic to the medication sildenafil
  • Babies who are currently being treated with a medication called fluconazole (an antifungal medicine) at the time the study drug would be started
  • Cases where a parent or guardian is unable to give consent within 24 hours of the heart ultrasound
  • Babies who are currently on a life support machine called ECMO (a machine that helps the heart and lungs work) at the time of the study

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 21 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: 801-213-3360

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
15 September 2022
Est. completion
31 March 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change in Left Ventricular Eccentricity Index (LVEI) on echocardiogram after 14 days of study treatment compared to baseline echocardiogram as compared to placebo.

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 21 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov