Recruiting PHASE4 Heart Failure With Reduced Ejection Fraction (HFrEF)

New treatment option for Heart Failure With Reduced Ejection Fraction (HFrEF)

Official title Vericiguat and Reverse Remodeling Indices in Heart Failure

ClinicalTrials.gov ID: NCT07405944

What this study is testing

What is Vericiguat?

Vericiguat is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for heart failure with reduced ejection fraction (hfref).

Also referred to as Verquvo, MK-1242.

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
The goal of this clinical trial is to investigate how vericiguat benefits adults with stable heart failure with reduced ejection fraction (HFrEF) who are already receiving guideline-directed medical therapy. The main questions are: Does vericiguat improve right ventricular systolic function, measured by tricuspid annular plane systolic excursion (TAPSE)?
  • Phase 4: studies an already-approved treatment
  • Time commitment: about 12 months
  • Which group you join is decided by chance.

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

Who can take part

Ages 18 and older

You may be able to join if

  • Written informed consent from an adult patient (≥ 18 years old) to participate in the clinical study,
  • Stable HFrEF defined as no heart failure worsening in the 6 months before randomization that required hospitalization or outpatient diuretic...
  • Confirmed diagnosis of chronic heart failure with reduced ejection fraction (LVEF ≤ 40%, confirmed by echocardiography) within 12 months before...
  • Stable GDMT for HFrEF for at least 3 months prior to randomisation.

You likely can't join if

  • Systolic blood pressure \< 100 mmHg or symptomatic hypotension,
  • Current or planned use of long-acting nitrates, soluble guanylate cyclase stimulators, or phosphodiesterase type V inhibitors,
  • Known allergy/hypersensitivity to soluble guanylate cyclase stimulators,
  • Awaiting heart transplantation or dependence on continuous inotropic therapy
  • Cardiac amyloidosis, sarcoidosis, myocarditis, stress cardiomyopathy, or tachycardic cardiomyopathy,
  • Acute coronary syndrome, coronary artery bypass grafting, or percutaneous coronary intervention in the past three months before randomisation,
See the full eligibility criteria
Who can join
  • Written informed consent from an adult patient (≥ 18 years old) to participate in the clinical study,
  • Stable HFrEF defined as no heart failure worsening in the 6 months before randomization that required hospitalization or outpatient diuretic treatment,
  • Confirmed diagnosis of chronic heart failure with reduced ejection fraction (LVEF ≤ 40%, confirmed by echocardiography) within 12 months before randomization,
  • Stable GDMT for HFrEF for at least 3 months prior to randomisation.
What rules you out
  • Systolic blood pressure \< 100 mmHg or symptomatic hypotension,
  • Current or planned use of long-acting nitrates, soluble guanylate cyclase stimulators, or phosphodiesterase type V inhibitors,
  • Known allergy/hypersensitivity to soluble guanylate cyclase stimulators,
  • Awaiting heart transplantation or dependence on continuous inotropic therapy
  • Cardiac amyloidosis, sarcoidosis, myocarditis, stress cardiomyopathy, or tachycardic cardiomyopathy,
  • Acute coronary syndrome, coronary artery bypass grafting, or percutaneous coronary intervention in the past three months before randomisation,
  • Long-term mechanical circulatory support of the left ventricle,
  • Active infection,
  • Chronic kidney disease stage 4 or 5, and
  • Advanced liver failure classified as Child-Pugh B or C.

The study team makes the final eligibility decision.

Where it's taking place

  • Ljubljana, Slovenia

Compensation & support

Compensation mentioned.

ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.

Questions & answers

Do participants get paid in this trial?

This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.

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 study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Ljubljana, Slovenia. 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.