Phase 3 study for people with Heart Disease

Recruiting Phase 3

Sources: ClinicalTrials.gov Checked: 11 October 2026 Not medical advice

This trial at a glance

Status Recruiting
Phase Phase 3
Sponsor Colorado Prevention Center
Registry number NCT06008197
Started 17 January 2024 Today 16 October 2026 Estimated completion 1 November 2027

Where this trial is running

Trial sites and the status recorded for each
SiteCityState or countryStatus at this site
Blacktown, NSW Investigative Site 50006 Blacktown NSW Recruiting
Milton, Queensland Investigative Site 50001 Milton QLD Recruiting
Elizabeth Vale, South Australia Investigative Site 50008 Elizabeth Vale SA Recruiting
Melbourne, VIC Investigative Site 50005 Melbourne VIC Recruiting
Mulgrave, Victoria Investigative Site 50004 Mulgrave VIC Recruiting
Adelaide Investigative Site 50007 Adelaide SA Recruiting

voxsanity.com.au · trial sites from public registries · registry record synced 11 October 2026 · not medical advice

Who can join

Age 18 Years and over
Sex Anyone, regardless of sex
Healthy volunteers Not accepted
Enrolment target 5200

The official eligibility criteria

Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.

Inclusion Criteria:

* Provide written informed consent

* Age ≥18 years or legal age of majority if \>18 years in the participant's country of residence

* Current hospitalization or recently discharged (during or within 30 days of discharge) with the primary diagnosis of heart failure

* Heart failure signs and symptoms at the time of hospital admission

* Imaging evidence of mildly reduced or preserved left ventricular ejection fraction (EF) (40% or higher)

* Elevated N-terminal pro B-type natriuretic peptide (NTproBNP) ≥500 pg/mL or B-type natriuretic peptide (BNP) ≥125 pg/mL for patients without atrial fibrillation (AF); or elevated NTproBNP ≥1500 pg/mL or BNP ≥375 pg/mL for patients with AF

Exclusion Criteria:

* Current or planned long-term treatment with a mineralocorticoid receptor antagonist (MRA)

* Documented prior history of severe hyperkalemia in the setting of MRA use

* Estimated glomerular filtration rate (eGFR) \<25 mL/min/1.73m² or potassium \>5.0 mmol/L at screening

* Acute myocardial infarction due to plaque rupture, coronary revascularization, valve replacement/repair, or implantation of a cardiac resynchronization therapy device within 30 days

* Hemodynamically significant (severe) uncorrected primary cardiac valvular disease

* Cardiomyopathy due to known acute inflammatory heart, infiltrative diseases, accumulation diseases, muscular dystrophies, cardiomyopathy with reversible causes, known hypertrophic obstructive cardiomyopathy, complex congenital heart disease, or known pericardial constriction

* Probable alternative cause of participant's heart failure symptoms

* Concomitant systemic therapy with potent cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitors or moderate CYP3A4 inducers, or potent CYP3A4 inducers

* Known hypersensitivity to the IP (active substance or excipients)

Dates on the record

Started 17 January 2024
Estimated completion 1 November 2027
Registry last updated 10 September 2026
Checked by Voxsanity 11 October 2026

Results, publications and the official record

Sources and dates

  • ClinicalTrials.gov – the record this page reformats
  • ClinicalTrials.gov processing date: 10 September 2026.
  • This page last checked by Voxsanity: 11 October 2026.

Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.

Not medical advice.

Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.

Letter for your doctor

A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.