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NCT06363110: HOVER
An Observational Study to Learn More About Vericiguat Treatment Patterns and Its Safety in People With Chronic Heart Failure With Reduced Ejection Fraction in Routine Medical Care in the United States
trial testing Vericiguat (Verquvo, BAY1021189) in Chronic Heart Failure With Reduced Ejection Fraction in 1,400 participants. Completed in 24 June 2024.
24 June 2024
Quick facts
| Lead sponsor | Bayer |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 1,400 |
| Start date | 10 April 2024 |
| Primary completion | 24 June 2024 |
| Estimated completion | 24 June 2024 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Vericiguat (Verquvo, BAY1021189) — full drug profile →
Conditions studied
- Chronic Heart Failure With Reduced Ejection Fraction — all drugs for Chronic Heart Failure With Reduced Ejection Fraction →
Sponsor
Bayer — full company profile →
Who can join
18 and older, any sex, with Chronic Heart Failure With Reduced Ejection Fraction. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is an observational study in which data already collected from people with chronic heart failure with reduced ejection fraction (HFrEF) are studied. In observational studies, only observations are made, without participants receiving any advice or any changes to healthcare. Chronic HFrEF is a long-term condition in which the heart becomes weak and cannot pump enough blood to the rest of the body with each heartbeat. This leads to a reduced supply of oxygen, which the body requires to function properly. The study treatment, vericiguat, works by increasing the activity of an enzyme called soluble guanylate cyclase (sGC), which relaxes the blood vessels and allows more blood to flow. As a result, the heart can pump better. It is already approved for doctors to prescribe to people with chronic HFrEF in the United States (US) who are stabilized after a recent "decompensation event". The treatment with vericiguat starts at a low dose, which should be increased gradually to the target dose based on how a patient tolerates the treatment. The participants in this study are already receiving treatment with vericiguat as part of their regular care from their doctors. The main purpose of the study is to learn more about the dosage pattern of vericiguat in people with chronic HFrEF in the US. To do this, researchers will collect the following information for 3 months after participants' first dose of vericiguat: * starting dose of vericiguat * daily changes in dosage pattern * time taken to reach the target dose * number and percentage of participants: * with specific changes in dosage pattern * reaching the target dose of vericiguat They will also collect information on how often low blood pressure or fainting occurs, which are well known events in people with chronic HFrEF. The data will come from the participants' information stored in a database called the HealthVerity HF dataset. Data collected will be from people with chronic HFrEF who started taking vericiguat between January 2021 and April 2023. Researchers will only look at the health records of participants in the US. Researchers will track participants' data and will collect information for a maximum of 6 months before and 3 months after their first dose of vericiguat. In this study, only available data from routine care are collected. No visits or tests are required as part of this study.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06363110
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Related trials
Other trials of Vericiguat (Verquvo, BAY1021189)
Trials testing the same drug.
- NCT06632483 — An Observational Study to Learn More About How Safe Vericiguat is and How Well it Works in Indian People With Chronic He · active not recruiting
- NCT06486844 — An Observational Study Called ROVER to Learn More About How Well Vericiguat Works in People Who Were Newly Treated With · completed
- NCT06148935 — An Observational Study to Learn More About the Use of Vericiguat in Korean People With Chronic Heart Failure With Reduce · recruiting
- NCT05728502 — An Observational Study, Called VERI-China, to Learn More About How Well Vericiguat Works and How Safe it is in Real-worl · completed
- NCT05658458 — A Study to Learn How Well the Drug Vericiguat Works and How Safe it is Under Real World Conditions in Indian Participant · Phase 4 · completed
Other recruiting trials for Chronic Heart Failure With Reduced Ejection Fraction
Currently open trials in the same condition.
- NCT06632483 — An Observational Study to Learn More About How Safe Vericiguat is and How Well it Works in Indian People With Chronic He · active not recruiting
- NCT06148935 — An Observational Study to Learn More About the Use of Vericiguat in Korean People With Chronic Heart Failure With Reduce · recruiting
- NCT05553886 — S086 Tablets for Chronic Heart Failure With Reduced Ejection Fraction · Phase 3 · recruiting
Other Bayer trials
Trials by the same sponsor.
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- NCT07490431 — An Observational Study to Learn More About How Elinzanetant is Used and How Well it Works for Women With Menopause Sympt · not yet recruiting
- NCT05477953 — An Observational Pregnancy Safety Study in Women Who Were Exposed to the Drug Nifurtimox During Pregnancy to Learn About · not yet recruiting
- NCT07192952 — A Study to Learn More About How Safe Finerenone is, When it is Taken for a Longer Time With Standard Treatment, in Child · Phase 3 · not yet recruiting
- NCT07450599 — A Study to Learn How Well a Combination of Darolutamide and Androgen Deprivation Therapy (ADT) Works as a Treatment Befo · Phase 2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06363110 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Bayer
- Last refreshed: 3 July 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06363110.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing