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- || Gencaro (bucindolol) / ARCA Biopharma
Retrospective data, Review, Journal: Comparative Efficacy of Different Drugs for the Treatment of Dilated Cardiomyopathy: A Systematic Review and Network Meta-analysis. (Pubmed Central) - Aug 21, 2023
If LVEF and HR do not meet the standard, ivabradine can also be used in combination with other treatments. However, since the quality and number of studies in our research were limited, large sample size, multi-center, and high-quality randomized controlled trials are required to corroborate our findings.
- ||| Gencaro (bucindolol) / ARCA Biopharma
With well powered RCTs of efficacious therapies for same disease state, replication can be achieved (and exceptions like BEST, bucindolol due to differences in specific drug) (Twitter) - Apr 25, 2023
- ||| Gencaro (bucindolol) / ARCA Biopharma
Journal, Adverse events: Dose-limiting, adverse event-associated bradycardia with β-blocker treatment of atrial fibrillation in the GENETIC-AF trial. (Pubmed Central) - Mar 5, 2022
On multivariate analysis of 21 candidate bradycardia predictors including presence of a device with pacing capability, bucindolol treatment was associated with the greatest degree of prevention (Z -4.24, P < .0001). In AF-prone HF patients bradycardia may limit the effectiveness of β blockers, and this property is agent-dependent.
- | Gencaro (bucindolol) / ARCA Biopharma
Journal: Right Ventricular Ejection Fraction and Beta-Blocker Effect in Heart Failure with Reduced Ejection Fraction: Beta-Blocker and outcomes in HFrEF by RVEF. (Pubmed Central) - Mar 1, 2022
The effect of bucindolol on mortality in patients with HFrEF was modified by baseline RVEF. If these hypothesis-generating findings can be replicated using approved beta-blockers in contemporary patients with HFrEF, then RVEF may help risk-stratify patients with HFrEF for optimization of beta-blocker therapy.
- | Gencaro (bucindolol) / ARCA Biopharma, Tekturna (aliskiren) / PDL
Retrospective data, Journal: Model-based meta-analysis of changes in circulatory system physiology in patients with chronic heart failure: MBMA of circulatory system physiology in CHF. (Pubmed Central) - Feb 1, 2022
The analysis based on the present models were reasonably consistent with the hypothesis that the treatment of HFrEF with various medications is due to effectively reducing the cardiac load. Assessment of circulatory physiological parameters by using MBMA would be insightful for quantitative understanding of CHF treatment.
- || Gencaro (bucindolol) / ARCA Biopharma
Clinical, Journal: Bucindolol Decreases Atrial Fibrillation Burden in Patients with Heart Failure and the ADRB1 Arg389Arg Genotype. (Pubmed Central) - Dec 29, 2021
Reductions in plasma norepinephrine (p = 0.038) and NT-proBNP (p = 0.009) were also observed with bucindolol compared to metoprolol. Conclusions - Compared with metoprolol, bucindolol reduced AF burden, improved maintenance of sinus rhythm, and lowered the need for additional rhythm control interventions in patients with HF and the ADRB1 Arg389Arg genotype.
- | Gencaro (bucindolol) / ARCA Biopharma
Journal, HEOR: Ex Ante Economic Evaluation of Arg389 Genetically Targeted Treatment with Bucindolol versus Empirical Treatment with Carvedilol in NYHA III/IV Heart Failure. (Pubmed Central) - Oct 28, 2021
Conclusions - Compared with metoprolol, bucindolol reduced AF burden, improved maintenance of sinus rhythm, and lowered the need for additional rhythm control interventions in patients with HF and the ADRB1 Arg389Arg genotype. This independent ex ante economic evaluation suggests that genetically targeted treatment with bucindolol is unlikely to yield clinicoeconomic benefits over empirical treatment with carvedilol in NYHA III/IV HF.
- ||| Gencaro (bucindolol) / ARCA Biopharma
As far as I know, the argument against a class effect for MRA is absence of large trials like FIDELIO, etc for spiro, not evidence that spiro doesn't work in this population (in contrast to other distinct examples of no class effect, i.e. bucindolol not improving HFrEF outcomes) (Twitter) - Aug 31, 2021
- ||||| Gencaro (bucindolol) / ARCA Biopharma
Clinical: On continuous monitoring, bucindolol leads to significant ⬇️ in #Afib burden & interventions with ⬇️ in NE and NTproBNP in #HF patients with ADRB1 genotype. 💪🏻Continuous monitoring. https://t.co/GdfbPC9HXX @JonPicciniSr @S_NarayanMD @DrJasonAndrade @CirculationEP #EPeeps (Twitter) - Aug 20, 2021
- || Gencaro (bucindolol) / ARCA Biopharma
$ABIO Gencaro Atrial Fibrillation Phase 2B Results Selected for Publication in Circulation: Arrhythmia and Electrophysiology https://t.co/4S7DPS7e8b (Twitter) - Jul 28, 2021
- |||| Gencaro (bucindolol) / ARCA Biopharma
Clinical: not exactly - https://t.co/89Wqaeu9cr. Bucindolol failed to improve prognosis in HF at the BEST trial. But now they try to use it not at every HF patient, but only in patients with HF and the ADRB1 Arg389Arg genotypes (Twitter) - Jul 23, 2021
- || Gencaro (bucindolol) / ARCA Biopharma
Clinical, Journal: GENETIC-AF: Bucindolol for the Maintenance of Sinus Rhythm in a Genotype-Defined Heart Failure Population. (Pubmed Central) - Oct 16, 2020
This independent ex ante economic evaluation suggests that genetically targeted treatment with bucindolol is unlikely to yield clinicoeconomic benefits over empirical treatment with carvedilol in NYHA III/IV HF. Pharmacogenetic-guided bucindolol therapy did not reduce the recurrence of AF/AFL/ACM compared to metoprolol in HFrEF patients, but populations were identified that merit further investigation in future Phase 3 trials.
- Gencaro (bucindolol) / ARCA Biopharma
[VIRTUAL] Gender, Race, and Age Specific Baseline Predictors of All-Cause Mortality in BEST Identified by Machine Learning (OnDemand) - Oct 10, 2020 - Abstract #AHA2020AHA_5115;
P3
Background NHLBI supported Beta-Blocker Evaluation in Survival Trial (BEST) (NCT00000560) was designed to determine if bucindolol hydrochloride would reduce the death rate in patients with moderate to severe heart failure and a left ventricular ejection fraction ≤ 35 percent...Conclusion Using ML, we found in an unbiased fashion, novel unanticipated predictors of ACM in BEST trial. This underscores the value of gender, race and age groups specific predictors of hard associated with CV disease and efficacy of therapeutic interventions in advancing precision medicine.
- | Gencaro (bucindolol) / ARCA Biopharma
Journal: GENETIC-AF: Digging Deeper Into Genotype-Phenotype and Heart Failure-Atrial Fibrillation Interactions. (Pubmed Central) - Jun 8, 2020
This underscores the value of gender, race and age groups specific predictors of hard associated with CV disease and efficacy of therapeutic interventions in advancing precision medicine. No abstract available
- Gencaro (bucindolol) / ARCA Biopharma
Bucindolol Is Associated With A Lower Incidence Of Dose Limiting Bradycardia In Heart Failure Patients With Atrial Fibrillation: The Genetic-AF Trial (Room 7) - Apr 22, 2020 - Abstract #RHYTHM2020RHYTHM_3232;
No abstract available In a pharmacogenetically-defined HF population at risk for AF, bucindolol was associated with a lower incidence of dose limiting bradycardia compared to metoprolol succinate.
- Gencaro (bucindolol) / ARCA Biopharma, metoprolol succinate / Generic mfg.
Impact Of Pharmacogenetic-guided Bucindolol Versus Metoprolol Succinate On The Overall Burden Of Clinical Events In Patients With Atrial Fibrillation And Heart Failure: The Genetic-af Trial (Room 6A Foyer) - Apr 22, 2020 - Abstract #RHYTHM2020RHYTHM_1810;
In a pharmacogenetically-defined HF population at risk for AF, bucindolol was associated with a lower incidence of dose limiting bradycardia compared to metoprolol succinate. In a pharmacogenetically-defined HF population at risk for AF recurrence, bucindolol was associated with fewer AF interventions and CV AEs compared to the active control metoprolol succinate.
- Gencaro (bucindolol) / ARCA Biopharma, metoprolol succinate / Generic mfg.
Pharmacogenomic Guided Beta-blocker Therapy Withbucindolol Reduces Atrial Fibrillation Burden Compared To Metoprolol Succinate: The Genetic-af Trial (Poster Hall) - Apr 22, 2020 - Abstract #RHYTHM2020RHYTHM_746;
In a pharmacogenetically-defined HF population at risk for AF recurrence, bucindolol was associated with fewer AF interventions and CV AEs compared to the active control metoprolol succinate. In a pharmacogenetically-defined HF population at risk for AF recurrence, bucindolol significantly decreased the cumulative AF burden compared to the active control metoprolol succinate.
- | Gencaro (bucindolol) / ARCA Biopharma, sirolimus / Generic mfg.
Journal: Bucindolol Modulates Cardiac Remodeling by Attenuating Oxidative Stress in H9c2 Cardiac Cells Exposed to Norepinephrine. (Pubmed Central) - Jan 5, 2020
The protein kinase B/mammalian target of the rapamycin (Akt/mTOR) pathway which is involved in cardiac remodeling process was activated in response to norepinephrine and was mitigated by bucindolol. In conclusion, bucindolol was able to modulate cardiac remodeling which is mediated by oxidative stress.
- | Gencaro (bucindolol) / ARCA Biopharma
Journal: Dose Response of β-Blockers in Adrenergic Receptor Polymorphism Genotypes. (Pubmed Central) - Sep 28, 2019
Other BBs taken at low dose have reduced efficacy for Arg389Arg genotype subjects compared with 389Gly carriers, suggesting a greater relative treatment effect at high dose. These data support guideline recommendations to use high, clinical trial target doses of all BBs to treat HF with reduced ejection fraction.
- Gencaro (bucindolol) / ARCA Biopharma
Ppharmacogenetic Guided Beta-blocker Therapy with Bucindolol for the Prevention of Atrial Fibrillation/flutter in Heart Failure: Relationship of Left Ventricular Ejection Fraction to Treatment Effect () - Sep 9, 2019 - Abstract #HFSA2019HFSA_1300;
- |||| Gencaro (bucindolol) / ARCA Biopharma
Clinical: Congratulations but without any clinical interest. Bucindolol is ineffective in BEST trial, there are 4 betablockers effective to treat this syndrome (Twitter) - Apr 30, 2019
- | Gencaro (bucindolol) / ARCA Biopharma
Clinical, Journal, HEOR: A genotype-directed comparative effectiveness trial of Bucindolol and metoprolol succinate for prevention of symptomatic atrial fibrillation/atrial flutter in patients with heart failure: Rationale and design of the GENETIC-AF trial. (Pubmed Central) - Apr 19, 2019
P2
GENETIC-AF is the first randomized trial of pharmacogenetic guided rhythm control, and will test the safety and efficacy of bucindolol compared with metoprolol succinate for the prevention of recurrent symptomatic AF/AFL in patients with HFrEF and an ADRB1 Arg389Arg genotype. (ClinicalTrials.govNCT01970501).
- |||| Gencaro (bucindolol) / ARCA Biopharma
Trial completion, HEOR: GENETIC-AF: Genetically Targeted Therapy for the Prevention of Symptomatic Atrial Fibrillation in Patients With Heart Failure (clinicaltrials.gov) - Jan 9, 2018
P2, N=267, Completed, Sponsor: ARCA Biopharma, Inc.
(ClinicalTrials.govNCT01970501). Active, not recruiting --> Completed
- ||| Gencaro (bucindolol) / ARCA Biopharma
Enrollment closed, HEOR: GENETIC-AF: Genetically Targeted Therapy for the Prevention of Symptomatic Atrial Fibrillation in Patients With Heart Failure (clinicaltrials.gov) - Aug 22, 2017
P2, N=250, Active, not recruiting, Sponsor: ARCA Biopharma, Inc.
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- ||| Gencaro (bucindolol) / ARCA Biopharma
Enrollment change, HEOR: GENETIC-AF: Genetically Targeted Therapy for the Prevention of Symptomatic Atrial Fibrillation in Patients With Heart Failure (clinicaltrials.gov) - Apr 20, 2016
P2, N=250, Recruiting, Sponsor: ARCA Biopharma, Inc.
Recruiting --> Active, not recruiting N=200 --> 250
- | Gencaro (bucindolol) / ARCA Biopharma
Phase classification, HEOR: GENETIC-AF: Genetically Targeted Therapy for the Prevention of Symptomatic Atrial Fibrillation in Patients With Heart Failure (clinicaltrials.gov) - Mar 18, 2015
P2, N=200, Recruiting, Sponsor: ARCA Biopharma, Inc.
N=200 --> 250 Phase classification: P2/3 --> P2
- |||||| Gencaro (bucindolol) / ARCA Biopharma
Enrollment open, HEOR: GENETIC-AF: Genetically Targeted Therapy for the Prevention of Symptomatic Atrial Fibrillation in Patients With Heart Failure (clinicaltrials.gov) - Mar 2, 2014
P2/3, N=620, Recruiting, Sponsor: ARCA Biopharma, Inc.
Phase classification: P2/3 --> P2 Not yet recruiting --> Recruiting
- |||||||||| Gencaro (bucindolol) / ARCA Biopharma
New P2/3 trial, HEOR: GENETIC-AF: Genetically Targeted Therapy for the Prevention of Symptomatic Atrial Fibrillation in Patients With Heart Failure (clinicaltrials.gov) - Oct 24, 2013
P2/3, N=620, Recruiting, Sponsor: ARCA Biopharma, Inc.