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| Name | Class |
|---|---|
| Aarhus University Hospital | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vericiguat THEN Placebo | Other | Oral vericiguat tablet (2.5, 5, and 10 mg) for first period. |
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| Placebo THEN Vericiguat | Other | Oral placebo tablet (2.5, 5, and 10 mg) for first period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Pulmonary arterial pressure (diastolic) | From baseline to the end of treatment at 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| N-Terminal Pro-B-Type Natriuretic Peptide | From baseline to the end of treatment at 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Benjamin L Hansen, MD | Contact | +4535456261 | benjamin.lautrup.hansen.01@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Finn Gustafsson, Professor | Rigshospitalet, Denmark | Principal Investigator |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D000081029 | Pulmonary Arterial Hypertension |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D006976 | Hypertension, Pulmonary |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| C000603960 | vericiguat |
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| 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) |
|
| D012140 |
| Respiratory Tract Diseases |