NCT06671990

The CardioMEMS Vericiguat Heart Failure Trial

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 17 (estimated)
• Sponsor: Finn Gustafsson · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Heart Failure
• Pulmonary Arterial Hypertension

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2024-12-01
• Primary completion: 2024-12-01
• Completion: 2026-01-31
• First posted: 2024-11-04
• Last updated: 2024-11-04

Regulatory

• FDA-regulated drug study