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Telmisartan in Haemodialysis Patients With Chronic Heart Failure

Primary Purpose

Heart Failure, Congestive

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
telmisartan
Sponsored by
University of Campania "Luigi Vanvitelli"
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure, Congestive focused on measuring heart Failure, haemodialysis, telmisartan, angiotensin converting enzyme inhibitor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chair of Cardiology Second University of Naples

Outcomes

Primary Outcome Measures

all cause mortality cardiovascular mortality hospitalization for decompensated heart failure

Secondary Outcome Measures

acute non-fatal myocardial infarction
combined endpoint (cardiovascular mortality in addition to acute non-fatal myocardial infarction)
cardiovascular hospital admission
nonfatal stroke
coronary revascularization
permanent premature treatment withdrawals

Full Information

First Posted
June 22, 2007
Last Updated
October 16, 2008
Sponsor
University of Campania "Luigi Vanvitelli"
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1. Study Identification

Unique Protocol Identification Number
NCT00490958
Brief Title
Telmisartan in Haemodialysis Patients With Chronic Heart Failure
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2007
Overall Recruitment Status
Completed
Study Start Date
January 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Campania "Luigi Vanvitelli"

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Congestive
Keywords
heart Failure, haemodialysis, telmisartan, angiotensin converting enzyme inhibitor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
351 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
telmisartan
Primary Outcome Measure Information:
Title
all cause mortality cardiovascular mortality hospitalization for decompensated heart failure
Time Frame
36 months
Secondary Outcome Measure Information:
Title
acute non-fatal myocardial infarction
Time Frame
36 months
Title
combined endpoint (cardiovascular mortality in addition to acute non-fatal myocardial infarction)
Time Frame
36 months
Title
cardiovascular hospital admission
Time Frame
36 months
Title
nonfatal stroke
Time Frame
36 months
Title
coronary revascularization
Time Frame
36 months
Title
permanent premature treatment withdrawals
Time Frame
36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gennaro Cice, MD
Organizational Affiliation
Chair of cardiology Second University of Naples
Official's Role
Study Chair
Facility Information:
Facility Name
Chair of Cardiology Second University of Naples
City
Naples
ZIP/Postal Code
80100
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
21070920
Citation
Cice G, Di Benedetto A, D'Isa S, D'Andrea A, Marcelli D, Gatti E, Calabro R. Effects of telmisartan added to Angiotensin-converting enzyme inhibitors on mortality and morbidity in hemodialysis patients with chronic heart failure a double-blind, placebo-controlled trial. J Am Coll Cardiol. 2010 Nov 16;56(21):1701-8. doi: 10.1016/j.jacc.2010.03.105.
Results Reference
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Telmisartan in Haemodialysis Patients With Chronic Heart Failure

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