Phase 3 study

Recruiting Phase 3

Sources: ClinicalTrials.gov Checked: 15 October 2026 Not medical advice

This trial at a glance

Status Recruiting

Phase Phase 3

Sponsor Boehringer Ingelheim

Registry number NCT07064473

Started 22 July 2025 Today 16 October 2026 Estimated completion 14 December 2029

Where this trial is running

Trial sites and the status recorded for each
Site	City	State or country	Status at this site
Canberra Hospital	Garran	ACT	Recruiting
Blacktown Hospital	Blactown	NSW	Recruiting
Advara Heartcare Research Burwood	Burwood	NSW	Recruiting
Royal Prince Alfred Hospital	Camperdown	NSW	Recruiting
Concord Repatriation General Hospital	Concord	NSW	Recruiting
Sydney Cardiometabolic Centre	Liverpool	NSW	Recruiting
John Hunter Hospital	New Lambton Heights	NSW	Recruiting
Royal North Shore Hospital	St Leonards	NSW	Recruiting
Heart of Australia	Chelmer	QLD	Recruiting
Prince Charles Hospital	Chermside	QLD	Recruiting
Royal Brisbane and Women's Hospital	Herston	QLD	Completed
Life Clinical Research	Ipswich	QLD	Recruiting
Gold Coast University Hospital	Southport	QLD	Recruiting
Toowoomba Hospital	Toowoomba	QLD	Recruiting
Nightingale Research Pty Ltd	Adelaide	SA	Recruiting
Flinders Medical Centre	Bedford Park	SA	Recruiting
Advara Heart Care-Leabrook-69072	Leabrook	SA	Recruiting
Royal Hobart Hospital	Hobart	TAS	Recruiting
Monash Health	Clayton	VIC	Recruiting
The Northern Hospital	Epping	VIC	Recruiting
Nightingale Research Victoria	Frankston	VIC	Recruiting
Heartwest	Hoppers Crossing	VIC	Recruiting
Cabrini Health	Malvern	VIC	Recruiting
Advara HeartCare - Mulgrave	Mulgrave	VIC	Recruiting
Advara Heartcare Research WA	Joondalup	WA	Recruiting
Fiona Stanley Hospital	Murdoch	WA	Recruiting
St John of God Subiaco Hospital	Subiaco	WA	Recruiting

voxsanity.com.au · trial sites from public registries · registry record synced 15 October 2026 · not medical advice

Who can join

Age 18 Years and over

Sex Anyone, regardless of sex

Healthy volunteers Not accepted

Enrolment target 11800

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 :

* At least 18 years old at time of consent

* Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial

* Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2).

* Participants with medical history of hypertension and on active pharmacological treatment

* Participants with medical history of type 2 diabetes mellitus (T2DM) and on active pharmacological treatment

* Established cardiovascular (CV) disease and on active pharmacological treatment

* At least one additional risk factor for developing heart failure (HF)

Exclusion Criteria:

* History of HF or hospitalization for HF or treatment of HF

* Atrial fibrillation or Atrial flutter with a resting heart rate \>110 beats per minute (bpm) documented by echocardiogram (ECG) at Visit 1 (screening)

* Advanced untreated conduction disease or untreated clinically relevant ventricular arrhythmia at Visit 1 (screening)

* Treatment with an Mineralocorticoid receptor antagonist (MRA)

* Treatment with amiloride or other potassium-sparing diuretic

* Receiving the following treatments at Visit 1 (screening) or requiring such treatment before Visit 2 (randomisation), or planned during the trial:

* A direct renin inhibitor (e.g. aliskiren)

* More than one Angiotensin-converting enzyme inhibitor (ACEi) and/or Angiotensin receptor blocker (ARB) (including Angiotensin receptor-neprilysin inhibitor (ARNi)) used simultaneously

* Other aldosterone synthase inhibitors (e.g. baxdrostat)

* Systemic mineralocorticoid replacement therapy (e.g. fludrocortisone) Further exclusion criteria apply.

Dates on the record

Started 22 July 2025

Estimated completion 14 December 2029

Registry last updated 14 October 2026

Checked by Voxsanity 15 October 2026

Results, publications and the official record

No results are posted on the official record yet.
No publications are listed on the official record yet.
Official record and contacts on ClinicalTrials.gov – contact details for each site are kept there, and are not copied onto this page.

Sources and dates

ClinicalTrials.gov – the record this page reformats
ClinicalTrials.gov processing date: 14 October 2026.
This page last checked by Voxsanity: 15 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.

Voxsanity

Clinical trials recruiting in Australia, from the public registries · voxsanity.com.au

Date:

To: My Doctor

Re: Clinical trial enquiry

I am writing to enquire about the following clinical trial, which may be relevant to my care:

Trial: NCT07064473

Sponsor: Boehringer Ingelheim

Phase: Phase 3

Status: Recruiting

More information: https://clinicaltrials.gov/study/NCT07064473

Eligibility criteria, as the registry published them

Reproduced exactly, unedited. Written for researchers rather than for patients.

Inclusion Criteria :

At least 18 years old at time of consent
Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2).
Participants with medical history of hypertension and on active pharmacological treatment
Participants with medical history of type 2 diabetes mellitus (T2DM) and on active pharmacological treatment
Established cardiovascular (CV) disease and on active pharmacological treatment
At least one additional risk factor for developing heart failure (HF)

Exclusion Criteria:

History of HF or hospitalization for HF or treatment of HF
Atrial fibrillation or Atrial flutter with a resting heart rate >110 beats per minute (bpm) documented by echocardiogram (ECG) at Visit 1 (screening)
Advanced untreated conduction disease or untreated clinically relevant ventricular arrhythmia at Visit 1 (screening)
Treatment with an Mineralocorticoid receptor antagonist (MRA)
Treatment with amiloride or other potassium-sparing diuretic
Receiving the following treatments at Visit 1 (screening) or requiring such treatment before Visit 2 (randomisation), or planned during the trial:
- A direct renin inhibitor (e.g. aliskiren)
- More than one Angiotensin-converting enzyme inhibitor (ACEi) and/or Angiotensin receptor blocker (ARB) (including Angiotensin receptor-neprilysin inhibitor (ARNi)) used simultaneously
- Other aldosterone synthase inhibitors (e.g. baxdrostat)
- Systemic mineralocorticoid replacement therapy (e.g. fludrocortisone) Further exclusion criteria apply.

A treatment being studied in a clinical trial is generally not yet listed on the PBS. Where a medicine is not approved or not available through a trial, the TGA Special Access Scheme may allow a registered health practitioner to access unapproved therapeutic goods for individual patients.

Not medical advice. Voxsanity reformats information published by public registries. It does not give medical advice and is not a substitute for talking to your doctor.