Heart FailurePhase 4ARETHANCT06671990
The CardioMEMS Vericiguat Heart Failure Trial
A Phase 4 study testing Vericiguat in people with Heart Failure and Pulmonary Arterial Hypertension, run by Finn Gustafsson.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Pulmonary Arterial Hypertension
- What is being tested?
- Vericiguat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2024to 31 Jan 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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.
- Optimal and stable medical therapy for HF (as indicated under point 5 of exclusion criteria)
- SBP ≥100 mmHg
- dPAP >15 mmHg more than 8 days in the last 14 days on the CardioMEMS system.
Who cannot join
- 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.
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- 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.
- Tachycardia-induced cardiomyopathy and/or uncontrolled tachyarrhythmia 15. Acute coronary syndrome (unstable angina, non-ST elevation myocardial infarction [NSTEMI], or ST elevation myocardial infarction [STEMI] or coronary revascularization (coronary artery bypass grafting [CABG] or percutaneous coronary intervention [PCI]) within 60 days, or indication for coronary revascularization at first study visit.
- 16. Symptomatic carotid stenosis, transient ischemic attack (TIA) or stroke within 60 days 17. Complex congenital heart disease 18. Active endocarditis or constrictive pericarditis 19. eGFR <15 mL/min/1.73 m2 or chronic dialysis. 20. Severe hepatic insufficiency such as with hepatic encephalopathy 21. Malignancy or other non-cardiac condition limiting life expectancy to <1 years.
- 22. Require continuous home oxygen for severe pulmonary disease. 23. Current alcohol and/or drug abuse. 24. Participating in another interventional clinical study or plans to participate in any other trial/investigation during the duration of this study.
- 25. Mental or legal incapacitation and is unable to provide informed consent. 26. Immediate family member (e.g., spouse, parent/legal guardian, sibling, or child) who is involved with this study.
- 27. Interstitial Lung Disease. 28. Is pregnant or breastfeeding (or lactating) or plans to become pregnant or to breastfeed during the course of the study.
- 29. Females of reproductive age and childbearing potential not using at least one safe form of contraception.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
- Being tested
- Vericiguat, Placebo
- Medical subject headings
- Heart Failure, Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VericiguatDrug
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)
PlaceboDrug
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)
| Study group | Role | What they receive |
|---|---|---|
| Vericiguat THEN Placebo | Other | Oral vericiguat tablet (2.5, 5, and 10 mg) for first period. Receives: Drug: Vericiguat |
| Placebo THEN Vericiguat | Other | Oral placebo tablet (2.5, 5, and 10 mg) for first period. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary arterial pressure (diastolic)
Measured: From baseline to the end of treatment at 6 weeks
Secondary outcomes (1)
N-Terminal Pro-B-Type Natriuretic Peptide
Measured: From baseline to the end of treatment at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start1 Dec 2024 (estimated)
- Primary completion1 Dec 2024 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 17 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Finn Gustafsson
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Sponsor-investigator, Finn Gustafsson, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Finn Gustafsson, Professor, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06671990
- Sponsor's protocol ID
- 2024-514111-10-00
- Acronym
- ARETHA
- Status last verified
- Nov 2024
- First submitted
- 1 Nov 2024
- Last updated
- 4 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The CardioMEMS Vericiguat Heart Failure Trial
- ClinicalTrials.gov ID
- NCT06671990
- Acronym / sponsor ID
- ARETHA / 2024-514111-10-00
- Conditions
- Heart Failure, Pulmonary Arterial Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 17 participants (estimated)
- Lead sponsor
- Finn GustafssonUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 4 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vericiguat THEN Placebo | Other | Drug: VericiguatOral vericiguat tablet (2.5, 5, and 10 mg) for first period. |
| Placebo THEN Vericiguat | Other | Drug: PlaceboOral placebo tablet (2.5, 5, and 10 mg) for first period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- ≥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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VericiguatParticipants 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 | Vericiguat THEN Placebo |
| PlaceboParticipants 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 THEN Vericiguat |
Primary outcome
Pulmonary arterial pressure (diastolic)
Time frame: From baseline to the end of treatment at 6 weeks
1 secondary outcome
N-Terminal Pro-B-Type Natriuretic Peptide
Time frame: From baseline to the end of treatment at 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Finn Gustafsson, Professor principal investigator
Copenhagen University Hospital, Rigshospitalet
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vericiguat in people with Heart Failure and Pulmonary Arterial Hypertension, run by Finn Gustafsson.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Benjamin L Hansen, MD (+4535456261, benjamin.lautrup.hansen.01@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary arterial pressure (diastolic) (time frame: From baseline to the end of treatment at 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2024.