Effect of Doxycycline on Cardiac Remodelling in STEMI Patients

Heart Failure Clinical Trial

Official title:

Effect of Doxycycline on Cardiac Remodelling in Patients With ST-Elevation Myocardial Infarction (STEMI)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03960411
• Other study ID #: 01
• Status: Recruiting
• Phase: Phase 3
• Start date: May 25, 2019
• Est. completion date: November 2019

Study information

• Verified date: August 2019
• Source: Indonesia University
• Contact: Bambang Widyantoro, PhD
• Phone: +62 812 8164299
• Email: bambang_ui[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Subsequent to the loss of myocardium post-myocardial infarction (MI), the affected ventricle undergoes some dynamic structural and functional changes known as remodeling. Cardiac remodeling progresses into heart failure (HF). In this revolutionized percutaneous coronary intervention (PCI) era, the incidence of post-MI HF due to cardiac remodeling remains high. Current standard therapeutic interventions, for HF, aimed solely at correcting a low cardiac output do not necessarily impede HF progression. Recently, doxycycline was found to have an additional biological effect aside from their antimicrobial actions. From several experimental studies and clinical trials, doxycycline showed MMP inhibition activities that can prevent ventricular remodeling. This study aims to evaluate the role of doxycycline in cardiac remodeling prevention post-MI. Our hypothesis is that a better heart function will be observed in STEMI patients who receive a short period of doxycycline administration post-PCI.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: November 2019
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Onset of STEMI <12 hours

• Anterior wall STEMI or Killip grade II-III or LVEF <50%

• Undergoing primary PCI

Exclusion Criteria:

• Signs of infection (clinical judgement plus leukocyte count >15,000)

• STEMI mechanical complication

• Moderate-severe valvular disease

• Allergic to doxycycline

• Refuse to join the trial

Related Conditions & MeSH terms

• Anterior Wall Myocardial Infarction
• Heart Failure
• Infarction
• Myocardial Infarction
• Remodeling, Ventricular
• ST Elevation Myocardial Infarction
• Ventricular Remodeling

Intervention

Drug:
• Doxycycline 100Mg Capsule
Doxycycline capsule
• Placebo oral capsule
Capsule manufactured to mimic doxycycline 100 mg capsule

Locations

Country	Name	City	State
Indonesia	National Cardiovascular Center Harapan Kita Hospital	Jakarta

Sponsors (2)

Lead Sponsor	Collaborator
Felix Chikita Fredy, MD	National Cardiovascular Center Harapan Kita Hospital Indonesia

Country where clinical trial is conducted

Indonesia, 

References & Publications (1)

Cerisano G, Buonamici P, Valenti R, Sciagrà R, Raspanti S, Santini A, Carrabba N, Dovellini EV, Romito R, Pupi A, Colonna P, Antoniucci D. Early short-term doxycycline therapy in patients with acute myocardial infarction and left ventricular dysfunction to prevent the ominous progression to adverse remodelling: the TIPTOP trial. Eur Heart J. 2014 Jan;35(3):184-91. doi: 10.1093/eurheartj/eht420. Epub 2013 Oct 8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	high sensitivity-Troponin T	hs-Troponin T in ng/L	12 hours
Primary	high sensitivity-CRP	hs-CRP in mg/L	24 hours
Primary	NT-pro BNP	NT-pro BNP in pg/ml	5 days
Primary	netrophils	absolute amount per micro liters	24 hours
Primary	ST2	ST2 in ng/ml	24 hours
Secondary	Mortality rate	The number of deceased participants	4 months
Secondary	Heart failure incidence	Evaluating the occurrence of heart failure signs and/or symptoms	4 months
Secondary	Re-hospitalization rate	The number of patients re-admitted due to heart failure signs and/or symptoms	4 months
Secondary	Left ventricle function and dimension	Assessed through echocardiography	4 months

External Links

•   TIPTOP Trial