Ivabradine in Patients With Congestive Heart Failure

NCT04448899 | Completed Phase 4 DMC

• 1 other identifier: Ivabradine in CHF
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to assess the efficacy of Ivabradine therapy in patients with congestive heart failure using the cardiac biomarkers NT-Pro BNP and Neopterin.

Conditions

Congestive Heart Failure

Outcome Measures

Primary Outcomes (2)

• NT-Pro BNP

  Serum BNP (pg/ml)

  three months

• Neopterin

  Serum Neopterin (nmol/L)

  three months

Secondary Outcomes (1)

• Heart Rate

  Three Months

Study Arms (2)

Ivabradine

ACTIVE COMPARATOR

Patients administered Ivabradine 5 mg twice daily and doses (2.5, 5, 7.5 mg) were to be adjusted upwards or downwards at every visit according to HR at rest and tolerability. Patients were followed up after 1 week of initiation of ivabradine therapy then monthly till the end of the study.

Drug: Ivabradine Oral Tablet

Control

PLACEBO COMPARATOR

Patients administered a placebo twice daily. Patients were followed up after 1 week of initiation of the study then monthly till the end of the study.

Drug: Blacebo plus standard treatment

Interventions

Ivabradine Oral Tablet DRUG

Ivabradine 5 mg twice daily and doses (2.5, 5, 7.5 mg) were to be adjusted upwards or downwards at every visit according to HR at rest and tolerability plus their standard treatment.

Also known as: Procoralan 5 mg film-coated tablets

Ivabradine

Blacebo plus standard treatment DRUG

Blacebo plus standard treatment

Control

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• acute decompen¬sation (acute coronary syndromes and acute HF);
• hemodynamically significant valve disease;
• cer¬ebrovascular events during the previous 6 months;
• dysfunctional prosthetic heart valve;
• obstructive or non-obstructive cardiomyopathy; uncorrected congenital heart disease; active myocarditis;
• a his¬tory of resuscitation from sudden death; an absence of stable sinus rhythm, severe arrhythmias; HR \< 60 bpm; sick sinus syndrome; second-degree and third-degree atrioventricular block;
• severe obesity (body mass index \> 36 kg/m²);
• established or sus¬pected pulmonary diseases (vital capacity \< 80% or forced expiratory volume in 1 s \< 80% of age spe¬cific and sex-specific reference values);
• hemoglobin ≤ 11 g/dL;
• treatment with non-dihydropyridine calcium-channel blockers, class I antiarrhythmic agents, strong inhibitors of cytochrome P450-3A4, or QT interval-prolonging medications;
• acute and chronic kidney failure;
• pregnancy; hypo- and hy¬perthyroidism or acute infections.

Sponsors & Collaborators

• Damanhour University: lead

Study Sites (1)

Tanta University Hospital

Tanta, El-Gharbia, 31527, Egypt

Location

Related Publications (4)

• Komajda M, Tavazzi L, Francq BG, Bohm M, Borer JS, Ford I, Swedberg K; SHIFT Investigators. Efficacy and safety of ivabradine in patients with chronic systolic heart failure and diabetes: an analysis from the SHIFT trial. Eur J Heart Fail. 2015 Dec;17(12):1294-301. doi: 10.1002/ejhf.347. Epub 2015 Sep 16.

  PMID: 26377342 RESULT

• Tavazzi L, Swedberg K, Komajda M, Bohm M, Borer JS, Lainscak M, Ford I; SHIFT Investigators. Efficacy and safety of ivabradine in chronic heart failure across the age spectrum: insights from the SHIFT study. Eur J Heart Fail. 2013 Nov;15(11):1296-303. doi: 10.1093/eurjhf/hft102. Epub 2013 Jun 26.

  PMID: 23803951 RESULT

• Sasaki T, Takeishi Y, Suzuki S, Niizeki T, Kitahara T, Katoh S, Ishino M, Shishido T, Watanabe T, Kubota I. High serum level of neopterin is a risk factor of patients with heart failure. Int J Cardiol. 2010 Nov 19;145(2):318. doi: 10.1016/j.ijcard.2009.11.042. Epub 2010 Jan 6.

  PMID: 20051294 RESULT

• Richards M, Troughton RW. NT-proBNP in heart failure: therapy decisions and monitoring. Eur J Heart Fail. 2004 Mar 15;6(3):351-4. doi: 10.1016/j.ejheart.2004.01.003.

  PMID: 14987587 RESULT

MeSH Terms

Conditions

Heart Failure

Interventions

Ivabradine

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Rehab Werida, Lecturer

  Damanhour University, Faculty of Pharmacy

  STUDY DIRECTOR

• Jayda M Dogheim, B. Pharm

  Alexandria University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double-blind study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 24, 2020
• First Posted: June 26, 2020
• Study Start: June 1, 2020
• Primary Completion: February 1, 2021
• Study Completion: February 5, 2021
• Last Updated: August 4, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)