Vericiguat and Exercise Hemodynamics in Patients With HFrEF

NCT07697365 | Completed

• 1 other identifier: EVERHETT-HF
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Failure With Reduced Ejection Fraction; Chronic Heart Failure

Keywords

HFrEF; Vericiguat; Cardiopulmonary Exercise Testing; Exercise Right Heart Catheterization; Exercise Hemodynamics; Heart Failure

Outcome Measures

Primary Outcomes (2)

• Change in peak oxygen consumption (peak VO2) assessed by cardiopulmonary exercise testing

  Assessment of the change in peak oxygen consumption (peak VO₂) measured by cardiopulmonary exercise testing (CPET) between baseline and the 12-month follow-up.

  Baseline to 12 months

• Change in pulmonary capillary wedge pressure (PCWP)

  Assessment of the change in pulmonary capillary wedge pressure measured during exercise right heart catheterization between baseline and the 12-month follow-up.

  Baseline to 12 months

Secondary Outcomes (8)

• Change in VE/VCO2 slope

  Baseline to 12 months

• Change in mean pulmonary artery pressure (mPAP)

  Baseline to 12 months

• Change in cardiac output

  Baseline to 12 months

• Change in cardiac index

  Baseline to 12 months

• Change in pulmonary vascular resistance (PVR)

  Baseline to 12 months

Study Arms (2)

Vericiguat + GDMT

Participants receiving oral vericiguat in addition to maximally tolerated guideline-directed medical therapy (GDMT) as part of routine clinical care. Treatment decisions were made by the treating physician independently of the study protocol.

Drug: Vericiguat; Other: Guideline-directed medical therapy (GDMT) for heart failure

GDMT Alone

Participants receiving maximally tolerated guideline-directed medical therapy (GDMT) without vericiguat as part of routine clinical care. Treatment decisions were made by the treating physician independently of the study protocol.

Other: Guideline-directed medical therapy (GDMT) for heart failure

Interventions

Vericiguat DRUG

Oral vericiguat prescribed as part of routine clinical care in addition to maximally tolerated guideline-directed medical therapy (GDMT). Dose titration up to 10 mg once daily was performed according to the treating physician's clinical judgment and routine clinical practice.

Vericiguat + GDMT

Guideline-directed medical therapy (GDMT) for heart failure OTHER

Participants received maximally tolerated guideline-directed medical therapy (GDMT) according to contemporary heart failure management guidelines and routine clinical practice throughout the study period.

GDMT Alone; Vericiguat + GDMT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consisted of consecutive adult patients (≥18 years) with stable chronic heart failure with reduced ejection fraction (LVEF ≤40%) receiving maximally tolerated guideline-directed medical therapy (GDMT). Patients were clinically stable and underwent standardized cardiopulmonary exercise testing (CPET) and exercise right heart catheterization (ERHC) as part of their clinical evaluation at Alexandra General Hospital. Participants were prospectively enrolled and classified according to routine clinical treatment with GDMT alone or GDMT plus vericiguat.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Argyrios Ntalianis: lead

Study Sites (1)

Alexandra General Hospital

Athens, Attica, 11528, Greece

Location

MeSH Terms

Conditions

Heart Failure

Interventions

vericiguat

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Argyrios Ntalianis, MD, PhD

  Alexandra General Hospital, Athens, Greece

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Cardiologist Attending

Study Record Dates

• First Submitted: July 5, 2026
• First Posted: July 13, 2026
• Study Start: January 31, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: July 13, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)