NCT00490958

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
351

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 1999

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1999

Completed
6.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

June 22, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 25, 2007

Completed
Last Updated

October 17, 2008

Status Verified

November 1, 2007

First QC Date

June 22, 2007

Last Update Submit

October 16, 2008

Conditions

Heart Failure, Congestive

Keywords

heart Failurehaemodialysistelmisartanangiotensin converting enzyme inhibitor

Outcome Measures

Primary Outcomes (1)

  • all cause mortality cardiovascular mortality hospitalization for decompensated heart failure

    36 months

Secondary Outcomes (6)

  • acute non-fatal myocardial infarction

    36 months

  • combined endpoint (cardiovascular mortality in addition to acute non-fatal myocardial infarction)

    36 months

  • cardiovascular hospital admission

    36 months

  • nonfatal stroke

    36 months

  • coronary revascularization

    36 months

  • +1 more secondary outcomes

Interventions

telmisartanDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Hypotension during dialysis;
  • Atrial fibrillation;
  • Intolerant to low dose of telmisartan

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chair of Cardiology Second University of Naples

Naples, 80100, Italy

Location

Related Publications (1)

  • 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.

    PMID: 21070920DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

Telmisartan

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Gennaro Cice, MD

    Chair of cardiology Second University of Naples

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 22, 2007

First Posted

June 25, 2007

Study Start

January 1, 1999

Study Completion

June 1, 2005

Last Updated

October 17, 2008

Record last verified: 2007-11

Locations

IT(1)