Clinical Study of CMR to Evaluate the Effect of Ivabradine on the Improvement of Left Ventricular Remodeling in STEMI Patients After Primary PCI

NCT05348057 | Unknown Phase 4 DMC

• 1 other identifier: qg-2021-12-01
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

This study aim to investigate the effect of ivabradine on reducing infarct size and improving left ventricular remodeling after in patients undergoing primary PCI for ST-elevation myocardial infarction through myocardial enhanced MRI.

Conditions

Cardiovascular Diseases

Outcome Measures

Primary Outcomes (2)

• Myocardial infarct size according to MR delayed enhancement scan

  Two experienced MRI cardiologists analyzed the delayed enhancement image enhancement area of MRI to obtain the area of myocardial infarction through the Segment v1.9 post-processing software

  7 days after PCI

• main cardiovascular events

  Acute heart failure, recurrence of myocardial infarction, death from all causes, stroke, cardiac death, recurrent myocardial infarction, recurrent target vascular revascularization, re-admission because of angina pectoris or heart failure

  follow up in 6 months

Secondary Outcomes (1)

• change of the LVEF

  follow up in 6 months

Study Arms (2)

Ivabradine group

EXPERIMENTAL

The starting dose is 5 mg twice a day. After 2 weeks of treatment, if the patient's resting heart rate continues to be higher than 70 beats per minute, increase the dose to 7.5 mg twice a day. If the patient's resting heart rate continues to be less than 50 beats per minute or symptoms related to bradycardia occur, reduce the dose to 2.5 mg

Drug: Ivabradine

The control group

NO INTERVENTION

Interventions

Ivabradine DRUG

The starting dose is 5 mg twice a day. Adjust the dose according to the actual situation

Ivabradine group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• STEMI patients: typical chest pain lasting 30 min within the previous 12 h, a clear ST-segment elevation of N0.1 mV in ≥2 contiguous electrocardiographic leads, and elevated blood levels of troponin T
• patients were scheduled to undergo diagnostic cardiac angiography or percutaneous coronary interventions

You may not qualify if:

• had once treated by ivabradine
• history of myocardial infarction
• mechanical complications
• Unable to perform myocardial MRI
• liver and kidney failure
• malignant tumor
• unconscious

Sponsors & Collaborators

• Qian geng: lead

Study Sites (1)

Chinese People's Liberation Army General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

Related Publications (10)

• Logeart D, Gueffet JP, Rouzet F, Pousset F, Chavelas C, Solal AC, Jondeau G. Heart rate per se impacts cardiac function in patients with systolic heart failure and pacing: a pilot study. Eur J Heart Fail. 2009 Jan;11(1):53-7. doi: 10.1093/eurjhf/hfn016.

  PMID: 19147457 BACKGROUND

• De Ferrari GM, Mazzuero A, Agnesina L, Bertoletti A, Lettino M, Campana C, Schwartz PJ, Tavazzi L. Favourable effects of heart rate reduction with intravenous administration of ivabradine in patients with advanced heart failure. Eur J Heart Fail. 2008 Jun;10(6):550-5. doi: 10.1016/j.ejheart.2008.04.005. Epub 2008 May 16.

  PMID: 18486549 BACKGROUND

• Joannides R, Moore N, Iacob M, Compagnon P, Lerebours G, Menard JF, Thuillez C. Comparative effects of ivabradine, a selective heart rate-lowering agent, and propranolol on systemic and cardiac haemodynamics at rest and during exercise. Br J Clin Pharmacol. 2006 Feb;61(2):127-37. doi: 10.1111/j.1365-2125.2005.02544.x.

  PMID: 16433867 BACKGROUND

• Ekman I, Chassany O, Komajda M, Bohm M, Borer JS, Ford I, Tavazzi L, Swedberg K. Heart rate reduction with ivabradine and health related quality of life in patients with chronic heart failure: results from the SHIFT study. Eur Heart J. 2011 Oct;32(19):2395-404. doi: 10.1093/eurheartj/ehr343. Epub 2011 Aug 29.

  PMID: 21875859 BACKGROUND

• Tardif JC, O'Meara E, Komajda M, Bohm M, Borer JS, Ford I, Tavazzi L, Swedberg K; SHIFT Investigators. Effects of selective heart rate reduction with ivabradine on left ventricular remodelling and function: results from the SHIFT echocardiography substudy. Eur Heart J. 2011 Oct;32(20):2507-15. doi: 10.1093/eurheartj/ehr311. Epub 2011 Aug 29.

  PMID: 21875858 BACKGROUND

• Borer JS, Bohm M, Ford I, Komajda M, Tavazzi L, Sendon JL, Alings M, Lopez-de-Sa E, Swedberg K; SHIFT Investigators. Effect of ivabradine on recurrent hospitalization for worsening heart failure in patients with chronic systolic heart failure: the SHIFT Study. Eur Heart J. 2012 Nov;33(22):2813-20. doi: 10.1093/eurheartj/ehs259. Epub 2012 Aug 27.

  PMID: 22927555 BACKGROUND

• Borer JS, Bohm M, Ford I, Robertson M, Komajda M, Tavazzi L, Swedberg K; SHIFT Investigators. Efficacy and safety of ivabradine in patients with severe chronic systolic heart failure (from the SHIFT study). Am J Cardiol. 2014 Feb 1;113(3):497-503. doi: 10.1016/j.amjcard.2013.10.033. Epub 2013 Nov 9.

  PMID: 24332674 BACKGROUND

• Hidalgo FJ, Anguita M, Castillo JC, Rodriguez S, Pardo L, Duran E, Sanchez JJ, Ferreiro C, Pan M, Mesa D, Delgado M, Ruiz M. Effect of early treatment with ivabradine combined with beta-blockers versus beta-blockers alone in patients hospitalised with heart failure and reduced left ventricular ejection fraction (ETHIC-AHF): A randomised study. Int J Cardiol. 2016 Aug 15;217:7-11. doi: 10.1016/j.ijcard.2016.04.136. Epub 2016 Apr 19.

  PMID: 27167103 BACKGROUND

• Sisakian H, Sargsyan T, Khachatryan A. Effect of selective heart rate reduction through sinus node If current inhibition on severely impaired left ventricular diastolic dysfunction in patients with chronic heart failure. Acta Cardiol. 2016 Jun;71(3):317-22. doi: 10.2143/AC.71.3.3152092. No abstract available.

  PMID: 27594127 BACKGROUND

• Swedberg K, Komajda M, Bohm M, Borer J, Robertson M, Tavazzi L, Ford I; SHIFT Investigators. Effects on outcomes of heart rate reduction by ivabradine in patients with congestive heart failure: is there an influence of beta-blocker dose?: findings from the SHIFT (Systolic Heart failure treatment with the I(f) inhibitor ivabradine Trial) study. J Am Coll Cardiol. 2012 May 29;59(22):1938-45. doi: 10.1016/j.jacc.2012.01.020.

  PMID: 22617188 BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Ivabradine

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: December 5, 2021
• First Posted: April 27, 2022
• Study Start: August 1, 2021
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: April 27, 2022

Record last verified: 2022-04

Locations

CN (1)