REMOTE-HF
Research type
Research Study
Full title
A phase 1b double-blind, randomized, placebo-controlled, multicentre, dose titration study to evaluate the safety, tolerability, and pharmacokinetics of 4 weeks treatment with BAY 2413555 in participants with heart failure and implanted cardiac defibrillator or cardiac resynchronization devices
IRAS ID
1004663
Contact name
Martijn Joustra
Contact email
Sponsor organisation
Bayer AG
Eudract number
2021-005751-36
Clinicaltrials.gov Identifier
Research summary
Research Summary
The purpose of this study is to learn how safe BAY2413555 is compared to placebo in participants with chronic heart failure and implanted cardiac defibrillator, or cardiac resynchronization devices (ICD/CRT). A placebo is a treatment that looks like a medicine, but does not have any medicine in it. ICD/CRT are machines placed in the body that use an electric shock/impulse to reset the heart or get it beating correctly. To study the safety, the researchers will record all medical problems the participants may have during the study after starting the study treatment. Medical problems that happen after the participants have started their treatment are also known as “treatment emergent adverse events” (TEAEs). The TEAEs will be compared between participants who received BAY2413555 and those who received placebo. The second purpose of this study is to learn whether the conduction in the heart is changed after taking BAY2413555 compared to placebo. The following conditions will be considered for this analysis: any cardiac rhythm abnormalities and changes in heart rate. The study has two parts, A and B. Each part will last for two weeks. In part A, the participants will be assigned by chance to either take BAY2413555 as a tablet by mouth once per day or a placebo. Participants from part A who do not need to stop the study based on predefined criteria continue in part B. They will be assigned by chance to receive either the same dose of BAY2413555 as in part A or a higher dose. Participants who have taken placebo in part A will as well be assigned in part B. Each participant will be in the study for approximately 90 days (including the screening period and follow-up period). In the study, participants will take study medication for 28 days. 8 visits to the study site and 1 telephone contact visit are planned. About 30 days after the participants take their last treatment, the study doctors and their team will check the participants’ health.
Summary of Results
This is a summary of the main results for 22 participants. Individual results from each participant might be different and are not included in this summary. Researchers collected information about adverse events that happened after taking the study treatment. These events may or may not be related to the study treatment.
Percentage (number) of participants who had serious adverse events and adverse events;Group 1 (Total: 8 participants); BAY 2413555 Low dose
Serious adverse events - 0, Adverse events - 38% (3)
Group 2 (Total: 7 participants): BAY 2413555 Low dose followed by BAY 2413555 high dose
Serious adverse events - 14% (1), Adverse events - 71% (5)
Group 3 (Total: 7 participants): Placebo
Serious adverse events - 0, Adverse events - 29% (2)
The only serious adverse event that happened in this study was bulging and weakening of the aorta, the main blood vessel that carries oxygen-rich blood from the heart to other parts of the body. This serious adverse event was considered not related to BAY 2413555.
The adverse events were: Irregular and uncoordinated contractions of the upper chambers of the heart, Dizziness, Rapid heart rhythm in the lower chambers of the heart, Bulging and weakening of the aorta, Weakness, Back pain, Change in bowel habit, Diarrhea, Headache, Flu, Sensations like numbness, tingling, and pins and needles, Rash, Restricted blood flow to the fingers and toes, Sleepiness & Abnormal urine test values.
The researchers found that none of the participants experienced AV blocks or slow heart rate during this study.REC name
Wales REC 1
REC reference
22/WA/0209
Date of REC Opinion
23 Aug 2022
REC opinion
Further Information Favourable Opinion