Impact of Beta Blockers on TAVI (BETA-TAVI)

NCT05721170 | Recruiting Phase 4 DMC

• 1 other identifier: BETA-TAVI Trial
• Study Type: interventional
• Target: 347
• Locations: 2 countries
• Sites: 2

Brief Summary

This is a prospective, multicentre, investigator-initiated, randomized clinical trial clinical trial investigating the impact of beta-blockers administration among patients undergoing TAVI for severe aortic valve stenosis. Adults already receiving beta-blockers be assigned randomly in 1:1 ratio to either continue or withdraw the beta-blockers medication at least 72 hours before and at least 7 days after TAVI. The primary endpoint is permanent pacemaker implantation rates in 7 days after the procedure. Secondary endpoints include death, cardiogenic shock and arrhythmias/conduction abmormalities with time frame 12 months.

Conditions

Aortic Valve Stenosis

Keywords

TAVI; Aortic valve stenosis; TAVR; Pacemaker implantation; Beta blocker

Outcome Measures

Primary Outcomes (1)

• Permanent pacemaker implantation

  Permanent pacemaker implantation

  7 days

Secondary Outcomes (7)

• All-cause mortality

  12 months

• Cardiovascular mortality

  12 months

• Shock

  12 months

• Atrial fibrillation

  12 months

• Ventricular tachycardia/fibrillation

  12 months

Study Arms (2)

Beta-blockers continuation

ACTIVE COMPARATOR

Patients assigned in the beta-blockers continuation arm will be receiving per os beta blocker medication for at least 72 hours before TAVI without interruption after it.

Drug: Beta blocker

Beta-blockers interruption

ACTIVE COMPARATOR

Patients assigned to interrupt the beta-blockers treatment will abstain from beta blockers for at least 7 days after TAVI.

Drug: Beta blocker

Interventions

Beta blocker DRUG

Investigation on beta-blockers in TAVI and brief post-TAVI period.

Beta-blockers continuation; Beta-blockers interruption

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults ≥18 years old.
• Patient with severe symptomatic aortic stenosis defined by mean aortic gradient \> 40 mmHg or/and peak jet velocity \> 4.0 m/s or/and aortic valve area (AVA) \< 1cm2 or/and AVA indexed to body surface area (BSA) of \<0.6 cm2/m2.
• Patients are considered at high risk for mortality with conventional surgical aortic valve replacement as assessed by a Heart Team consisting of at least a cardiologist and surgeon.
• Patients with anatomic characteristics suitable for TAVI based on the local Heart Team decision.
• Patients receiving beta-blockers as a part of their indicated treatment plan.
• Patient understands the purpose, the potential risks as well as benefits of the trial and is willing to participate in all parts of the follow-up.
• Patient has given written consent to participate in the trial.

You may not qualify if:

• A known hypersensitivity or contraindication to any of the following which cannot be adequately pre-medicated: aspirin, heparin, bivalirudin, clopidogrel, titanium, nickel, cobaltium, chromium, contrast media.
• Patients with permanent pacemaker or defibrillator.
• Ongoing infection, including active endocarditis.
• Echocardiographic evidence of LV or LA thrombus.
• The patient that has any contraindication for antithrombotic treatment.
• Estimated life expectancy of less than 12 months.
• Pregnancy and pre-perimenopause.
• nd and 3rd degree atrioventricular (AV) block.
• Bradycardia (\<50 beats per minute) at the electrocardiogram (ECG) on the screening/baseline visit.
• Co-morbidity that excludes or significantly interferes with the follow-up visits.
• Enrolment in another study that competes or interferes with this study.

Sponsors & Collaborators

• National and Kapodistrian University of Athens: lead

Study Sites (2)

Nicosia General Hospital

Nicosia, Cyprus

RECRUITING

First Department of Cardiology, National and Kapodistrian University of Athens

Athens, Attica, 11527, Greece

RECRUITING

Related Publications (14)

• Aurigemma G, Battista S, Orsinelli D, Sweeney A, Pape L, Cuenoud H. Abnormal left ventricular intracavitary flow acceleration in patients undergoing aortic valve replacement for aortic stenosis. A marker for high postoperative morbidity and mortality. Circulation. 1992 Sep;86(3):926-36. doi: 10.1161/01.cir.86.3.926.

  PMID: 1516206 BACKGROUND

• Authors/Task Force members; Elliott PM, Anastasakis A, Borger MA, Borggrefe M, Cecchi F, Charron P, Hagege AA, Lafont A, Limongelli G, Mahrholdt H, McKenna WJ, Mogensen J, Nihoyannopoulos P, Nistri S, Pieper PG, Pieske B, Rapezzi C, Rutten FH, Tillmanns C, Watkins H. 2014 ESC Guidelines on diagnosis and management of hypertrophic cardiomyopathy: the Task Force for the Diagnosis and Management of Hypertrophic Cardiomyopathy of the European Society of Cardiology (ESC). Eur Heart J. 2014 Oct 14;35(39):2733-79. doi: 10.1093/eurheartj/ehu284. Epub 2014 Aug 29. No abstract available.

  PMID: 25173338 BACKGROUND

• Brugada J, Katritsis DG, Arbelo E, Arribas F, Bax JJ, Blomstrom-Lundqvist C, Calkins H, Corrado D, Deftereos SG, Diller GP, Gomez-Doblas JJ, Gorenek B, Grace A, Ho SY, Kaski JC, Kuck KH, Lambiase PD, Sacher F, Sarquella-Brugada G, Suwalski P, Zaza A; ESC Scientific Document Group. 2019 ESC Guidelines for the management of patients with supraventricular tachycardiaThe Task Force for the management of patients with supraventricular tachycardia of the European Society of Cardiology (ESC). Eur Heart J. 2020 Feb 1;41(5):655-720. doi: 10.1093/eurheartj/ehz467. No abstract available.

  PMID: 31504425 BACKGROUND

• Glikson M, Nielsen JC, Kronborg MB, Michowitz Y, Auricchio A, Barbash IM, Barrabes JA, Boriani G, Braunschweig F, Brignole M, Burri H, Coats AJS, Deharo JC, Delgado V, Diller GP, Israel CW, Keren A, Knops RE, Kotecha D, Leclercq C, Merkely B, Starck C, Thylen I, Tolosana JM; ESC Scientific Document Group. 2021 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy. Eur Heart J. 2021 Sep 14;42(35):3427-3520. doi: 10.1093/eurheartj/ehab364. No abstract available.

  PMID: 34455430 BACKGROUND

• Hindricks G, Potpara T, Dagres N, Arbelo E, Bax JJ, Blomstrom-Lundqvist C, Boriani G, Castella M, Dan GA, Dilaveris PE, Fauchier L, Filippatos G, Kalman JM, La Meir M, Lane DA, Lebeau JP, Lettino M, Lip GYH, Pinto FJ, Thomas GN, Valgimigli M, Van Gelder IC, Van Putte BP, Watkins CL; ESC Scientific Document Group. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS): The Task Force for the diagnosis and management of atrial fibrillation of the European Society of Cardiology (ESC) Developed with the special contribution of the European Heart Rhythm Association (EHRA) of the ESC. Eur Heart J. 2021 Feb 1;42(5):373-498. doi: 10.1093/eurheartj/ehaa612. No abstract available.

  PMID: 32860505 BACKGROUND

• Knuuti J, Wijns W, Saraste A, Capodanno D, Barbato E, Funck-Brentano C, Prescott E, Storey RF, Deaton C, Cuisset T, Agewall S, Dickstein K, Edvardsen T, Escaned J, Gersh BJ, Svitil P, Gilard M, Hasdai D, Hatala R, Mahfoud F, Masip J, Muneretto C, Valgimigli M, Achenbach S, Bax JJ; ESC Scientific Document Group. 2019 ESC Guidelines for the diagnosis and management of chronic coronary syndromes. Eur Heart J. 2020 Jan 14;41(3):407-477. doi: 10.1093/eurheartj/ehz425. No abstract available.

  PMID: 31504439 BACKGROUND

• Leon MB, Smith CR, Mack MJ, Makkar RR, Svensson LG, Kodali SK, Thourani VH, Tuzcu EM, Miller DC, Herrmann HC, Doshi D, Cohen DJ, Pichard AD, Kapadia S, Dewey T, Babaliaros V, Szeto WY, Williams MR, Kereiakes D, Zajarias A, Greason KL, Whisenant BK, Hodson RW, Moses JW, Trento A, Brown DL, Fearon WF, Pibarot P, Hahn RT, Jaber WA, Anderson WN, Alu MC, Webb JG; PARTNER 2 Investigators. Transcatheter or Surgical Aortic-Valve Replacement in Intermediate-Risk Patients. N Engl J Med. 2016 Apr 28;374(17):1609-20. doi: 10.1056/NEJMoa1514616. Epub 2016 Apr 2.

  PMID: 27040324 BACKGROUND

• Lioufas PA, Kelly DN, Brooks KS, Marasco SF. Unexpected suicide left ventricle post-surgical aortic valve replacement requiring veno-arterial extracorporeal membrane oxygenation support despite gold-standard therapy: a case report. Eur Heart J Case Rep. 2022 Feb 2;6(2):ytac020. doi: 10.1093/ehjcr/ytac020. eCollection 2022 Feb.

  PMID: 35233483 BACKGROUND

• Mack MJ, Leon MB, Thourani VH, Makkar R, Kodali SK, Russo M, Kapadia SR, Malaisrie SC, Cohen DJ, Pibarot P, Leipsic J, Hahn RT, Blanke P, Williams MR, McCabe JM, Brown DL, Babaliaros V, Goldman S, Szeto WY, Genereux P, Pershad A, Pocock SJ, Alu MC, Webb JG, Smith CR; PARTNER 3 Investigators. Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients. N Engl J Med. 2019 May 2;380(18):1695-1705. doi: 10.1056/NEJMoa1814052. Epub 2019 Mar 16.

  PMID: 30883058 BACKGROUND

• Saito T, Yoshijima N, Hase H, Yashima F, Tsuruta H, Shimizu H, Fukuda K, Naganuma T, Mizutani K, Araki M, Tada N, Yamanaka F, Shirai S, Tabata M, Ueno H, Takagi K, Higashimori A, Watanabe Y, Yamamoto M, Hayashida K. Impact of beta blockers on patients undergoing transcatheter aortic valve replacement: the OCEAN-TAVI registry. Open Heart. 2020 Jul;7(2):e001269. doi: 10.1136/openhrt-2020-001269.

  PMID: 32641381 BACKGROUND

• Vahanian A, Beyersdorf F, Praz F, Milojevic M, Baldus S, Bauersachs J, Capodanno D, Conradi L, De Bonis M, De Paulis R, Delgado V, Freemantle N, Gilard M, Haugaa KH, Jeppsson A, Juni P, Pierard L, Prendergast BD, Sadaba JR, Tribouilloy C, Wojakowski W; ESC/EACTS Scientific Document Group. 2021 ESC/EACTS Guidelines for the management of valvular heart disease. Eur J Cardiothorac Surg. 2021 Oct 22;60(4):727-800. doi: 10.1093/ejcts/ezab389. No abstract available.

  PMID: 34453161 BACKGROUND

• Younis A, Orvin K, Nof E, Barabash IM, Segev A, Berkovitch A, Guetta V, Assali A, Kornowski R, Beinart R. The effect of periprocedural beta blocker withdrawal on arrhythmic risk following transcatheter aortic valve replacement. Catheter Cardiovasc Interv. 2019 Jun 1;93(7):1361-1366. doi: 10.1002/ccd.28017. Epub 2018 Nov 29.

  PMID: 30489692 BACKGROUND

• Zeppenfeld K, Tfelt-Hansen J, de Riva M, Winkel BG, Behr ER, Blom NA, Charron P, Corrado D, Dagres N, de Chillou C, Eckardt L, Friede T, Haugaa KH, Hocini M, Lambiase PD, Marijon E, Merino JL, Peichl P, Priori SG, Reichlin T, Schulz-Menger J, Sticherling C, Tzeis S, Verstrael A, Volterrani M; ESC Scientific Document Group. 2022 ESC Guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death. Eur Heart J. 2022 Oct 21;43(40):3997-4126. doi: 10.1093/eurheartj/ehac262. No abstract available.

  PMID: 36017572 BACKGROUND

• Koliastasis L, Kim WK, Toutouzas K. Pacemaker Implantation After TAVR: Searching for the Golden Ratio. JACC Cardiovasc Interv. 2023 Aug 14;16(15):1946. doi: 10.1016/j.jcin.2023.06.002. No abstract available.

  PMID: 37587606 DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

Adrenergic beta-Antagonists

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs

Study Officials

• Leonidas Koliastasis, MD, MSc

  National and Kapodistrian University of Athens

  PRINCIPAL INVESTIGATOR

• Odysseas Katsaros, MD

  National and Kapodistrian University of Athens

  PRINCIPAL INVESTIGATOR

• Konstantinos Toutouzas, Professor

  National and Kapodistrian University of Athens

  STUDY DIRECTOR

Central Study Contacts

Leonidas Koliastasis, MD, MSc, PhD

CONTACT

6974270752; lkoliastasis@gmail.com

Odysseas Katsaros, MD

CONTACT

+306944362412; odykatsaros@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Cardiology

Model Details: Eligible patients will be assigned randomly in 1:1 ratio to either continue or withdraw the already receiving beta-blockers medication

Study Record Dates

• First Submitted: January 28, 2023
• First Posted: February 9, 2023
• Study Start: June 1, 2024
• Primary Completion (Estimated): January 30, 2028
• Study Completion (Estimated): January 31, 2028
• Last Updated: December 9, 2024

Record last verified: 2024-12

Locations

CY (1); GR (1)