Phase 2 Pulmonary Hypertension Trial, Recruiting NCT01712620 Sponsor: National Institutes of Health Clinical Center (CC) Condition: Pulmonary Hypertension
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Phase 2 Pulmonary Hypertension Trial, Recruiting

NCT01712620
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:

  • You have been diagnosed with a specific type of pulmonary hypertension (high blood pressure in the lungs) called WHO Group 1, confirmed by a heart catheter test showing specific pressure and resistance measurements in your lungs
  • You are either not taking any medication for your pulmonary hypertension, or your treatment has been stable (no new drugs, no dose changes) for at least the past 4 weeks with no change in your symptoms during that time
  • Women who can become pregnant must agree to use reliable birth control (such as hormonal methods, barrier methods, or abstinence) for the entire time they are in the study

Who may not be able to join:

  • You have severe right-sided heart failure with the worst level of symptoms (WHO/NYHA Class IV), along with scan evidence of severely poor heart function and physical signs such as swollen legs, fluid in the abdomen, or visible neck vein swelling
  • You have pulmonary hypertension caused by, or alongside, liver scarring (cirrhosis) with high liver blood pressure, shown by a history of fluid in the abdomen, mental confusion from liver disease, or enlarged blood vessels in the food pipe
  • You currently have an active infection (HIV patients with two recent low viral load results within the past 12 months may still be eligible — confirm with trial site)
  • You have taken the medications spironolactone or eplerenone in the past 30 days
  • You have a known or suspected allergy to spironolactone
  • You are pregnant or currently breastfeeding (all women who could become pregnant will need a pregnancy test before joining)
  • You are under 18 years old
  • You are unable to give written consent to take part in the study
  • You have chronic kidney disease with significantly reduced kidney function (below a certain level measured by a kidney function calculation — confirm with trial site)
  • Your blood potassium level is too high at the time of enrollment (above a certain threshold — confirm with trial site)
  • You are currently taking both an ACE inhibitor and an angiotensin receptor blocker (two types of blood pressure medicines) at the same time, OR you are already on the highest recommended dose of either one of these medicines
  • You are a woman currently taking a contraceptive pill that contains a ingredient called drospirenone

For the MRI scan part of the trial, you may not be able to take part if:

  • You have an implanted pacemaker, defibrillator, cochlear implant, nerve stimulator, or any other implanted device that is not safe for MRI
  • You have metal fragments in your eyes, embedded shrapnel, or aneurysm clips in your brain
  • Your doctor feels you are not well enough to tolerate an MRI scan
  • You need sedation to have an MRI
  • You are unable to enter or lie still in an MRI scanner due to severe obesity, claustrophobia, severe back pain, or a movement disorder

For the part of the MRI using a contrast dye (gadolinium):

  • You have had a severe allergic reaction to gadolinium contrast dye in the past, even after being given preventative medicines
  • Your kidney function is below a certain level (a stricter limit than the general kidney exclusion above — confirm with trial site)

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 28 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

Principal Investigator: Michael A Solomon, M.D., National Institutes of Health Clinical Center (CC)

Phone: (301) 496-9320

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
Sponsor
National Institutes of Health Clinical Center (CC)
Registry
ClinicalTrials.gov
Start date
10 January 2014
Est. completion
31 December 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change in placebo corrected 6-minute walk distance

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: 28 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