Recruiting PHASE3 Atrial Hypertension

New treatment option for Atrial Hypertension

Official title SGLT2 Inhibition for Cardiovascular Endpoint Reduction in Hypertension

ClinicalTrials.gov ID: NCT06804161

What this study is testing

What is SGLT2?

SGLT2 is an investigational medicine, being studied as a potential treatment for atrial hypertension.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
Hypertension (HTN) is a leading cause of cardiovascular disease (CVD). Despite existing therapies, patients with HTN still face substantial risks, due to pre-existing and ongoing end-organ damage due, in part, to inadequate blood pressure (BP) control.
  • Phase 3: a large, late-stage study

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 60 and older

You may be able to join if

  • Age ≥60 years
  • Systolic blood pressure \>140 mmHg or diastolic blood pressure \>90 mmHg in two measurements on different days for newly diagnosed hypertension, or...
  • A history of at least one CV event (myocardial infarction\ or stroke\ ; stable angina or clinical evidence of coronary heart disease; peripheral...

You likely can't join if

  • Known secondary cause of hypertension
  • Myocardial infarction or stroke within the previous 3 months
  • Symptomatic heart failure (including HFrEF, HFmEF, HFpEF)
  • History of Diabetes mellitus
  • History of ketoacidosis
  • Hepatic impairment (aspartate transaminase [AST] or alanine transaminase [ALT] \>3x the upper limit of normal [ULN])
See the full eligibility criteria
Who can join
  • Age ≥60 years
  • Systolic blood pressure \>140 mmHg or diastolic blood pressure \>90 mmHg in two measurements on different days for newly diagnosed hypertension, or through one measurement at the screening visit for patients with an...
  • A history of at least one CV event (myocardial infarction\ or stroke\ ; stable angina or clinical evidence of coronary heart disease; peripheral arterial disease; transient ischemic attack) or The presence of at least...
What rules you out
  • Known secondary cause of hypertension
  • Myocardial infarction or stroke within the previous 3 months
  • Symptomatic heart failure (including HFrEF, HFmEF, HFpEF)
  • History of Diabetes mellitus
  • History of ketoacidosis
  • Hepatic impairment (aspartate transaminase [AST] or alanine transaminase [ALT] \>3x the upper limit of normal [ULN])
  • eGFR \<25 mL/min/1.73 m2 (CKD-EPICr 2021 formula) at Visit 1
  • Receiving therapy with an SGLT2i within 8 weeks prior to randomization or previous intolerance to an SGLT2i
  • Participation in another clinical study with an investigational product during the last month prior to enrolment
  • Known allergy or hypersensitivity to SGLT2i
  • Women who are pregnant, nursing, or who plan to become pregnant while in the trial
  • Any medical condition - outside the renal and CV disease area - with a life expectancy of less than 2 years based on investigator's clinical judgement
  • Active malignancy requiring treatment at the time of visit 1 (with the exception of successfully treated basal cell or treated squamous cell carcinoma)
  • Inability to give informed consent

The study team makes the final eligibility decision.

Where it's taking place

  • Lübeck, Schleswig-Holstein, Germany

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 60 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Lübeck, Schleswig-Holstein, Germany. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.