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The CardioMEMS Vericiguat Heart Failure Trial

NCT06671990 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2024-11-04

No results posted yet for this study

Summary

The ARETHA trial is a national (Danish), multicenter, randomized, placebo-controlled, double-blind, cross-over, no run-in phase, phase 4, investigator-initiated clinical trial investigating the effect of vericiguat on diastolic pulmonary arterial pressure in patients with heart failure with reduced ejection fraction. Participants will receive both vericiguat and placebo with an intermediate wash-out period. Patients will randomly be allocated 1:1 to two 6-week treatment sequences: either vericiguat first then placebo, or vice versa. The study drug dose will be doubled every 2 weeks (e.g., 2.5, 5, and 10 mg).

Conditions

Interventions

DRUG

Vericiguat

Participants will receive vericiguat and placebo with a cross-over intermediate wash-out period. Patients will randomly be allocated 1:1 to two 6-week treatment sequences: either vericiguat first then placebo, or vice versa. The study drug dose will be doubled every 2 weeks (e.g., 2.5, 5, and 10 mg)

DRUG

Placebo

Participants will receive vericiguat and placebo with a cross-over intermediate wash-out period. Patients will randomly be allocated 1:1 to two 6-week treatment sequences: either vericiguat first then placebo, or vice versa. The study drug dose will be doubled every 2 weeks (e.g., 2.5, 5, and 10 mg)

Sponsors & Collaborators

  • Aarhus University Hospital

    collaborator OTHER

  • Finn Gustafsson

    lead OTHER

Principal Investigators

  • Finn Gustafsson, Professor · Rigshospitalet, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-01
Primary Completion
2024-12-01
Completion
2026-01-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06671990 on ClinicalTrials.gov