Heart Failure, Pulmonary Arterial Hypertension
Conditions
Brief 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).
Interventions
DRUGVericiguat
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)
DRUGPlacebo
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
Aarhus University Hospital
Finn Gustafsson
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. ≥18 years 2. Ability to provide informed consent. 3. CardioMEMS implanted for clinical indication (≥ 2 weeks prior to first visit). 4. Known CHF with LVEF \<45% (documented within the past 24 months by an imaging modality: echocardiography, nuclear imaging, LV angiography, or magnetic resonance imaging). 5. NYHA functional class II-IV symptoms. 6. Optimal and stable medical therapy for HF (as indicated under point 5 of
Exclusion criteria
) 7. SBP ≥100 mmHg 8. dPAP \>15 mmHg more than 8 days in the last 14 days on the CardioMEMS system.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pulmonary arterial pressure (diastolic) | From baseline to the end of treatment at 6 weeks |
Secondary
| Measure | Time frame |
|---|---|
| N-Terminal Pro-B-Type Natriuretic Peptide | From baseline to the end of treatment at 6 weeks |
Contacts
Primary ContactBenjamin L Hansen, MD
Outcome results
None listed