Vericiguat and Exercise Hemodynamics in Patients With HFrEF (NCT07697365) | Clinical Trial Compass
CompletedNot Applicable
Vericiguat and Exercise Hemodynamics in Patients With HFrEF
Greece40 participantsStarted 2024-01-31
Plain-language summary
Heart failure with reduced ejection fraction (HFrEF) is associated with impaired exercise capacity and abnormal exercise hemodynamics despite contemporary guideline-directed medical therapy (GDMT). Vericiguat, a soluble guanylate cyclase stimulator, has demonstrated clinical benefits in selected patients with HFrEF, but its effects on exercise physiology remain incompletely understood.
The EVERHETT-HF study is a prospective observational cohort study designed to evaluate the effects of treatment with vericiguat on exercise capacity and invasive exercise hemodynamics in patients with stable HFrEF receiving maximally tolerated guideline-directed medical therapy (GDMT). Participants undergo comprehensive cardiopulmonary exercise testing (CPET) and exercise right heart catheterization (ERHC) to assess functional and hemodynamic responses during exercise.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Adults aged ≥18 years. Chronic heart failure with reduced ejection fraction (LVEF ≤40%). Stable chronic heart failure receiving maximally tolerated guideline-directed medical therapy (GDMT).
Clinically stable for at least 6 months prior to enrollment without hospitalization for worsening heart failure or major modification of heart failure therapy.
Able to perform symptom-limited cardiopulmonary exercise testing (CPET). Eligible to undergo exercise right heart catheterization (ERHC). Able to provide written informed consent.
Exclusion Criteria:
Acute decompensated heart failure. Recent hospitalization for worsening heart failure (\<6 months). Systolic blood pressure \<110 mmHg. Estimated glomerular filtration rate (eGFR) \<15 mL/min/1.73 m². Severe hepatic dysfunction. Severe anemia (hemoglobin \<9 g/dL). Contraindication to right heart catheterization. Inability to perform CPET. Pregnancy or breastfeeding. Any condition judged by the treating physician to preclude safe participation.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial studied whether vericiguat improved peak oxygen consumption and pulmonary capillary wedge pressure during exercise — what do those two measurements actually tell us about how my heart failure might be affecting my ability to exercise, and are mine currently being tracked?
2Since this trial is already completed, has the results data been published yet, and if so, what did it show about whether vericiguat actually changed exercise capacity or heart pressures in people with HFrEF like me?
3Vericiguat is already FDA-approved for HFrEF — how does what this trial was specifically testing, the effect on exercise hemodynamics, go beyond what was already known, and does that change how you might think about prescribing it for me?
4This trial used cardiopulmonary exercise testing to measure outcomes — is that something I should be having done as part of my own care, and would the results help guide decisions about my treatment options?
5Given that this was listed as Phase NA, meaning it wasn't a standard drug-approval-phase trial, how should I think about the strength of evidence it provides compared to the larger trials that originally got vericiguat approved?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in peak oxygen consumption (peak VO2) assessed by cardiopulmonary exercise testing
Timeframe: Baseline to 12 months
2
Change in pulmonary capillary wedge pressure (PCWP)