Efficacy of Candesartan on Brain Natriuretic Peptide Levels in Subjects With Chronic Heart Failure

NCT00843154 | Terminated Phase 3

• 3 other identifiers: CANc-CHF14-TIF2005-001306-87U1111-1114-0042
• Study Type: interventional
• Target: 571
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine the effects of Candesartan, once daily (QD), added to ongoing chronic heart disease therapy in measuring brain natriuretic peptide in patients with chronic heart failure.

Conditions

Heart Failure

Keywords

Natriuretic Peptide, Brain; Biological Markers; Biomarkers; Cardiac Failure; Congestive Heart Failure; Heart Decompensation; Drug Therapy

Outcome Measures

Primary Outcomes (1)

• Change from baseline in Brain Natriuretic Peptide

  Week 12 or Final Visit.

Secondary Outcomes (6)

• Change from baseline in Brain Natriuretic Peptide

  Week 48 or Final Visit.

• Change from baseline in Aldosterone, Pentraxin-3 and C-Reactive Protein

  Week 48 or Final Visit.

• Change from baseline of New York Heart Association class

  Week 48 or Final Visit.

• Change from baseline of Left Ventricular Ejection Fraction, Left Ventricular Internal Diastolic Diameter, E wave peak velocity/A wave peak velocity, deceleration time of E wave, atrial dimensions, blood pressure and heart rate

  Week 48 or Final Visit.

• Persistence of active treatment and discontinuation rate

  Week 48 or Final Visit.

Study Arms (2)

Candesartan QD

EXPERIMENTAL

Drug: Candesartan and standard chronic heart disease therapy

Standard chronic heart disease therapy

ACTIVE COMPARATOR

Drug: Standard chronic heart disease therapy

Interventions

Candesartan and standard chronic heart disease therapy DRUG

Candesartan 4mg, tablets, orally, once daily and stable dose therapy for chronic heart disease for two weeks; then Candesartan increased up to 32mg, tablets, orally, once daily and stable dose therapy for chronic heart disease for up to 48 weeks.

Also known as: Blopress, Amias, Kenzen, Atacand, Blopressid

Candesartan QD

Standard chronic heart disease therapy DRUG

Candesartan placebo-matching tablets, orally, once daily and stable dose therapy for chronic heart disease for up to 48 weeks.

Standard chronic heart disease therapy

Eligibility Criteria

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

You may qualify if:

• Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
• Stable, symptomatic New York Heart Association II-IV Chronic Heart Failure with Left Ventricular Ejection Fraction less than or greater than or greater than or equal to 40% treated with standard therapy including Angiotensin Converting Enzyme-inhibitors and/or beta-blockers. Patients with Left Ventricular Ejection Fraction greater than or equal to 40% had to be hospitalized for cardiovascular events during the past 12 months.

You may not qualify if:

• History of prior treatment with Angiotensin-Receptor Blockers within two weeks from first.
• Severe or malignant hypertension (Systolic Blood Pressure / Diastolic Blood Pressure greater than 180/110 mmHg).
• Symptomatic hypotension.
• Acute myocardial infarction within one month from first visit.
• Stroke or transient ischemic attack within one month from first visit.
• Percutaneous transluminal coronary angioplasty or coronary artery by-pass graft within one month from first visit.
• Hemodynamically relevant arrhythmias.
• Implant of pacemakers, cardiac resynchronization therapy or cardioverters within 6 months prior the randomization.
• Hemodynamically relevant cardiac valvular defect.
• Constrictive pericarditis or active myocarditis.
• Likelihood of cardiac surgical intervention (of any type) during the overall treatment period.
• Evidence of angina pectoris in the previous month.
• Poorly controlled diabetes mellitus (glycemia greater than 140mg/mL or glycosylated hemoglobin greater than 8% obtained within three months from the study initiation).
• Untreated thyroid dysfunction.
• Renal artery stenosis.

Sponsors & Collaborators

• Takeda: lead

MeSH Terms

Conditions

Heart Failure

Interventions

candesartan; candesartan cilexetil

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Medical Director Director

  Takeda Italia Farmaceutici SpA

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 12, 2009
• First Posted: February 13, 2009
• Study Start: December 1, 2005
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: June 11, 2010

Record last verified: 2010-06