Phase 4 Heart Disease Trial, Recruiting NCT07281014 Sponsor: Yale University Condition: Heart Disease
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Phase 4 Heart Disease Trial, Recruiting

NCT07281014
Recruiting Phase 4

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:

  • People who have chronic, stable heart failure with symptoms that are mild or absent (known as NYHA Class I or II), and whose fluid levels are well managed
  • People whose kidneys are functioning above a certain level (confirm with trial site for exact threshold)
  • People whose blood potassium level falls within a specific normal range at the time of screening
  • People whose heart failure medications have been stable and are not expected to change during the 8-week study period
  • People who have not had a worsening heart failure episode in the past 60 days
  • People with a resting blood pressure reading above a certain level — the exact threshold differs depending on whether the person is already taking a type of medication called an MRA (confirm with trial site)

Who may not be able to join:

  • People with uncontrolled high blood pressure above a certain level
  • People with severe bladder problems
  • People currently taking a high dose of certain fluid or potassium-related medications (confirm with trial site for specific medications and doses)
  • People for whom starting or stopping the study medication spironolactone would be medically unsafe
  • People with a history of severely high potassium levels in their blood
  • People whose heart failure is highly sensitive to fluid changes, or who have certain specific heart conditions that would make the study treatment higher risk
  • People who are pregnant or breastfeeding
  • Women who are able to become pregnant and are not using a highly effective form of contraception — acceptable methods listed in the trial protocol include hormonal contraception (pill, patch, injection, implant, or vaginal ring), an intrauterine device (IUD or IUS), a surgical procedure to block the fallopian tubes, a vasectomised partner, or complete sexual abstinence — and agreement to continue contraception until at least 14 days after the last study dose is required

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 20 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Principal Investigator: Jeffrey Testani, MD, Yale University

Phone: 2037857917

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 4
Sponsor
Registry
ClinicalTrials.gov
Start date
27 January 2026
Est. completion
1 August 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

change in urine sodium to potassium ratio

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: 20 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