The CardioMEMS Vericiguat Heart Failure Trial

NCT06671990 | Not Yet Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 2024-514111-10-00
• Study Type: interventional
• Target: 17
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Heart Failure; Pulmonary Arterial Hypertension

Outcome Measures

Primary Outcomes (1)

• Pulmonary arterial pressure (diastolic)

  From baseline to the end of treatment at 6 weeks

Secondary Outcomes (1)

• N-Terminal Pro-B-Type Natriuretic Peptide

  From baseline to the end of treatment at 6 weeks

Study Arms (2)

Vericiguat THEN Placebo

OTHER

Oral vericiguat tablet (2.5, 5, and 10 mg) for first period.

Drug: Vericiguat

Placebo THEN Vericiguat

OTHER

Oral placebo tablet (2.5, 5, and 10 mg) for first period.

Drug: Placebo

Interventions

Vericiguat DRUG

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)

Vericiguat THEN Placebo

Placebo DRUG

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)

Placebo THEN Vericiguat

Eligibility Criteria

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

You may qualify if:

• ≥18 years
• Ability to provide informed consent.
• CardioMEMS implanted for clinical indication (≥ 2 weeks prior to first visit).
• Known CHF with LVEF \<45% (documented within the past 24 months by an imaging modality: echocardiography, nuclear imaging, LV angiography, or magnetic resonance imaging).
• NYHA functional class II-IV symptoms.

You may not qualify if:

• SBP ≥100 mmHg
• dPAP \>15 mmHg more than 8 days in the last 14 days on the CardioMEMS system.
• Patients in optimization phase in the CardioMEMS system or implantation of the CardioMEMs device within the past 2 weeks.
• Recent (within 14 days) hospitalization for decompensated HF.
• Average supine SBP \<100 mmHg at the screening or randomization visit.
• Current symptomatic hypotension
• Recent changes (within 48 hours) in diuretic dose, recent (within 4 weeks) initiation of hydralazine, long-acting nitrates, β-blockers, ACEi/ARB or ARNi.
• Marked variability in PA diastolic pressure during screening period.
• Low CardioMEMS reading compliance (\<75% 30 days reading compliance).
• Concurrent or anticipated use of: o Long-acting nitrates or nitric oxide (NO) doners including isosorbide dinitrate, isosorbide 5-mononitrate, pentaerythritol tetranitrate, nicorandil or transdermal nitroglycerin (NTG) patch, and molsidomine. o sGC stimulators such as riociguat. o PDE5 inhibitors such as vardenafil, tadalafil, and sildenafil. o Intravenous inotropes.
• Previous or planned LVAD or HTx implantation.
• Implantation of CRT device within the previous 90 days.
• Known allergy or sensitivity to any sGC stimulator.
• Primary valvular heart disease requiring surgery or intervention or is within 3 months after valvular surgery or intervention.
• Diagnosed with hypertrophic obstructive cardiomyopathy, acute myocarditis, amyloidosis, sarcoidosis, or takotsubo cardiomyopathy.

Sponsors & Collaborators

• Finn Gustafsson: lead
• Aarhus University Hospital: collaborator

MeSH Terms

Conditions

Heart Failure; Pulmonary Arterial Hypertension

Interventions

vericiguat

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Finn Gustafsson, Professor

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Benjamin L Hansen, MD

CONTACT

+4535456261; benjamin.lautrup.hansen.01@regionh.dk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 1, 2024
• First Posted: November 4, 2024
• Study Start: December 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: January 31, 2026
• Last Updated: November 4, 2024

Record last verified: 2024-11