Status:
UNKNOWN
Significance of Regional Ventriculo-arterial Coupling in Patients With Chronic Heart Failure
Lead Sponsor:
Taipei Veterans General Hospital, Taiwan
Collaborating Sponsors:
National Science and Technology Council, Taiwan
Conditions:
Heart Failure
Eligibility:
All Genders
18-90 years
Phase:
PHASE4
Brief Summary
Heart failure is a major health problem worldwide. Optimal treatment of this disabling and fatal condition may require functional characterization of the failed left ventricle (LV) and its interaction...
Detailed Description
In the proposed 3-year project, we hypothesize that the different components of arterial load are coupled with different components of LV function. The regional ventriculo-arterial couplings may be im...
Eligibility Criteria
Inclusion
- 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. -
Exclusion
- 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.
- Presence of hemodynamically significant mitral and/or aortic valve disease, except mitral regurgitation secondary to left ventricular dilatation.
- Presence of other hemodynamically significant obstructive lesions of left ventricular outflow tract, including aortic and sub-aortic stenosis.
- Severe primary pulmonary, renal or hepatic disease.
- Presence of any other disease with a life expectancy of \< 1 year.
- Chronic long-term requirement for NSAIDs (high dose) or COX2 inhibitors, with the exception of aspirin at doses used for CV prophylaxis (≤325 mg o.d.).
- Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of study drugs
- Subjects get pregnant or will be pregnant within 6 months.
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT01156207
Start Date
July 1 2010
Last Update
July 2 2010
Active Locations (2)
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1
National Taiwan University Hospital
Taipei, Taiwan
2
Taipei Veterans General Hospital
Taipei, Taiwan