Telmisartan in Haemodialysis Patients With Chronic Heart Failure

Heart Failure, Congestive Clinical Trial

Official title:

Effects Of Telmisartan Added To Angiotensin Converting Enzyme Inhibitors On Mortality And Morbidity In Haemodialysed Patients With Chronic Heart Failure: A Double-Blind Placebo-Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00490958
• Other study ID #: tchf-01-01
• Status: Completed
• Phase: Phase 4
• First received: June 22, 2007
• Last updated: October 16, 2008
• Start date: January 1999
• Est. completion date: June 2005

Study information

• Verified date: November 2007
• Source: Second University of Naples
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Background: In haemodialysis patients, chronic heart failure (CHF) is responsible for a high mortality rate but, presently, very little data is available regarding this population.

Aim of the study: Aim of this study was to determine whether telmisartan decreases all-cause and cardiovascular mortality and morbidity in haemodialysis patients with CHF and impaired left ventricular ejection fraction (LVEF) when added to standard therapies with ACE inhibitors.

Methods: A 3-year randomized, double-blind, placebo-controlled, multicentre trial was performed involving 30 Italian clinics. Haemodialysis patients with CHF (NYHA class II and III; LVEF 40%) were randomized to telmisartan or placebo in addition to ACE inhibitor therapy. 332 patients were enrolled (165 telmisartan, 167 placebo), and drug dosage was titrated to a target dose of telmisartan of 80 mg or placebo. Mean follow-up period was 35±5 months. Primary outcomes were all-cause mortality, cardiovascular mortality and CHF hospitalization.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 351
• Est. completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult haemodialysis patients with CHF;

• New York Heart Association (NYHA) class II and III;

• Ejection fraction less or equal to 40% determined within 6 months; and

• Therapy with ACE inhibitors individually optimized and unchanged for 30 days before randomization

Exclusion Criteria:

• Hypotension during dialysis;

• Atrial fibrillation;

• Intolerant to low dose of telmisartan

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Congestive

Intervention

Drug:
• telmisartan

Locations

Country	Name	City	State
Italy	Chair of Cardiology Second University of Naples	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Second University of Naples

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	all cause mortality cardiovascular mortality hospitalization for decompensated heart failure		36 months
Secondary	acute non-fatal myocardial infarction		36 months
Secondary	combined endpoint (cardiovascular mortality in addition to acute non-fatal myocardial infarction)		36 months
Secondary	cardiovascular hospital admission		36 months
Secondary	nonfatal stroke		36 months
Secondary	coronary revascularization		36 months
Secondary	permanent premature treatment withdrawals		36 months