Phase 1 Heart Disease Trial, Recruiting NCT05753059 Sponsor: Yale University Condition: Heart Disease
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Phase 1 Heart Disease Trial, Recruiting

NCT05753059
Recruiting Phase 1

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 been clinically diagnosed with heart failure
  • People whose doctors have no plans to change or adjust their heart failure medications or devices during the study period
  • People who have not had an unplanned hospital stay in the past 2 weeks
  • People whose fluid levels are considered stable and well-managed by their medical team
  • People whose blood potassium level is 5.0 mmol/L or below
  • People whose blood sodium level is 130 mEq/L or above
  • People who are older than 18 years of age
  • People whose haemoglobin (a measure of red blood cells) is 8 g/dL or above
  • People whose test results show that their body is not responding well enough to a standard water tablet (diuretic) challenge, based on specific measurements of sodium in the urine and other kidney function indicators (confirm with trial site)

Who may not be able to join:

  • People whose kidneys are functioning at a very low level (confirm with trial site) or who are on dialysis or another form of kidney replacement therapy
  • People who have taken certain types of water tablets (non-loop diuretics) in the last 7 days or so, with some exceptions for low-dose medications — the trial site can clarify which medications are affected
  • People with a history of sudden severe fluid build-up in the lungs requiring hospitalisation and breathing support, or people with a heart condition that makes their fluid balance particularly fragile, such as amyloid cardiomyopathy
  • People whose haemoglobin is below 8 g/dL or who have anaemia causing symptoms
  • People who are pregnant or breastfeeding
  • People who are unable to provide written informed consent or who would have difficulty following the study's procedures and appointments
  • People who have a chronic urinary retention condition that would make timed urine collection difficult
  • People currently taking lithium
  • People currently taking pimozide or thioridazine
  • People who have been diagnosed with liver failure
  • People who have an allergy or medical reason to avoid sulfonamide-type medications
  • People who have an allergy or medical reason to avoid thiazide diuretics or the specific medication bendroflumethiazide

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 26 July 2026
Phase 1: approximately ~10% 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: Jeffrey Testani, Yale University

Phone: 203-737-3571

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 1
Sponsor
Registry
ClinicalTrials.gov
Start date
10 August 2023
Est. completion
1 June 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change in peak FENa from bumetanide monotherapy to bumetanide plus combination therapy; Change in distal sodium reabsorption; Correlation between distal sodium reabsorption and uEV pendrin/CD9

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: 26 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