Significance of Regional Ventriculo-arterial Coupling in Patients With Chronic Heart Failure

NCT01298258 | Unknown

• 1 other identifier: 99NSC-REVAC
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators hypothesize that the different components of arterial load are coupled with different components of LV function. The regional ventriculo-arterial couplings may be important in the pathogenesis of heart failure and ventricular remodeling, and in the prediction of future cardiovascular events.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• CV mortality and HF re-admission

  1 year after enrollment

Secondary Outcomes (1)

• Ventricular function

  1 year after enrollment

Study Arms (2)

placebo

PLACEBO COMPARATOR

control group

Drug: Aliskiren

Aliskiren

EXPERIMENTAL

Aliskiren 150 mh

Drug: Aliskiren

Interventions

Aliskiren DRUG

Aliskiren 150mg

Aliskiren; placebo

Eligibility Criteria

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

You may qualify if:

• Outpatients ≥ 18 years of age, male or female. Female patients must be either post-menopausal for one year, surgically sterile, or using effective contraceptive methods such as oral contraceptives, barrier method with spermicide or an intrauterine device.
• Patients with a diagnosis of chronic heart failure (NYHA Class II-IV) and reduced systolic function: LVEF ≤ 45% at Visit 1 (local measurement, measured within the past 6 months assessed by echocardiogram, MUGA, CT scan, MRI or ventricular angiography).
• NT-pro BNP ≥ 600pg/ml (BNP ≥ 150 pg/ml) at Visit 1 or NT-pro BNP ≥ 450 pg/mL (BNP (≥ 100 pg/ml) and a hospitalization for HF within last 12 months
• Patients must be on a stable dose of either an ACE inhibitor or an ARB for at least 4 weeks prior to Visit 1.
• Patients must be treated with a beta blocker, unless contraindicated or not tolerated, at a stable dose for at least 4 weeks prior to Visit 1.
• Patients with documented sinus rhythm at Visit 1.

You may not qualify if:

• History of hypersensitivity to any of the study drugs.
• Patients who require treatment with both ACEI and ARB.
• Current acute decompensated HF (exacerbation of chronic HF manifested by signs \& symptoms that may require IV therapy).
• Symptomatic hypotension and/or less than 100 mmHg at the time of screening or less than 90 mmHg at the time of randomization.
• eGFR \< 30 ml/min/1.73m2 as measured by the MDRD formula at Visit 1 (screening) , or a \> 25% decrease after 14 days of active run-in period.
• Serum potassium \> 5.0 mmol/L at screening (Visit 1).
• Acute coronary syndrome, stroke, transient ischemic attack, cardiac, carotid or major vascular surgery, percutaneous coronary intervention (PCI) or carotid angioplasty, within the past 3 months prior to visit 1.
• Coronary or carotid artery disease likely to require surgical or percutaneous intervention within the 6 months after Visit 1.
• Patients with active or unstable bronchospasm or asthma (patients must be on stable regimen of respiratory medications for 1 month prior to Visit 1).
• Right heart failure due to severe pulmonary disease.
• Diagnosis of peripartum or chemotherapy induced cardiomyopathy within the 12 months prior to visit 1.
• Patients with a history of heart transplant or who are on a transplant list or with left ventricular assistance device (LVAD device).
• Documented ventricular arrhythmia with syncopal episodes within past 3 months, prior to visit 1, that is untreated.
• Symptomatic bradycardia or second or third degree heart block without a pacemaker.
• Implantation of a CRT (cardiac resynchronization therapy) device within the prior 3 months from visit 1 or intent to implant a CRT device.

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead
• National Taiwan University Hospital: collaborator

Study Sites (1)

Taipei Veterans General Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Heart Failure

Interventions

aliskiren

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Chen-Huan chen, M.D.

  Taipei Veterans General Hospital, Taiwan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chen-Huan Chen, M.D.

CONTACT

886228752973

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: February 15, 2011
• First Posted: February 17, 2011
• Study Start: July 1, 2010
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: February 17, 2011

Record last verified: 2010-07

Locations

TW (1)