Status:
COMPLETED
Ranolazine in Diastolic Heart Failure
Lead Sponsor:
Gilead Sciences
Collaborating Sponsors:
University Medicine Göttingen, Cardiac Center
Conditions:
Diastolic Heart Failure
Eligibility:
All Genders
40+ years
Phase:
PHASE2
Brief Summary
Patients with CAD and clinical symptoms of heart failure or patients with suspected heart failure with preserved ejection fraction (HFpEF) will be enrolled. Study drug will be given as continuous IV i...
Detailed Description
This is a randomized, double-blind, placebo-controlled proof-of-concept study of ranolazine in patients with heart failure with preserved ejection fraction (HFpEF). Patients will be randomized to rece...
Eligibility Criteria
Inclusion
- Males or females aged \> 40 years
- Clinical symptoms of heart failure (NYHA class II-III) at time of screening (e.g., dyspnea, paroxysmal nocturnal dyspnea, orthopnea, bilateral lower extremity edema)
- Left ventricular ejection fraction (LVEF) \> 45% at screening
- With:
- E/E' \> 15 measured by Tissue Doppler echocardiography at screening
- NT-pro-BNP \> 220pg/mL at screening
- Average resting LVEDP \>18 mm Hg (refer to continued eligibility criteria),
- Average resting time constant of relaxation (tau) \> 50 ms at time of cardiac catheterization (refer to continued eligibility criteria)
- Signed informed consent
Exclusion
- Acute cardiac decompensation requiring mechanical ventilation
- Hypotension with blood pressure \< 90/50 mm Hg
- Primary hypertrophic or restrictive cardiomyopathy or systemic illness associated with infiltrative heart disease (e.g., cardiac amyloidosis)
- Pericardial constriction
- Hemodynamically significant uncorrected obstructive or regurgitant valvular disease
- Cor pulmonale or other causes of right heart failure not associated with left ventricular dysfunction
- Clinically significant pulmonary disease in the opinion of the Investigator or requiring home oxygen or oral steroid therapy
- History of serious cardiac dysrrhythmias including atrial fibrillation with resting heart rate of \> 100 beats per minute
- Need for treatment with Class I or III antiarrhythmic medications
- Implantable pacemaker, cardioverter-defibrillator, or left ventricular assist device
- Clinically significant chronic hepatic impairment (Child-Pugh Class B \[moderate\] or Class C \[severe\])
- Severe renal insufficiency defined as creatinine clearance ≤30 mL/min as calculated by Cockcroft-Gault formula or Modified Diet in Renal Disease (MDRD) equation.
- History of congenital or a family history of long QT syndrome, or known acquired QT interval prolongation
- Inability to exercise due to other co-morbidities that may affect performance of cardiopulmonary exercise test (CPET) (e.g., osteoarthritis, peripheral vascular disease)
- Current treatment with potent and moderate CYP3A inhibitors
- Current treatment with potent CYP3A inducers (e.g., rifampin/rifampicin, St. John's Wort, carbamazepin/carbamazepine)
- Prior treatment with ranolazine
- Other conditions that in the opinion of the investigator may increase the risk to the patient (e.g. pts with weight ≤60 kg), prevent compliance with study protocol or compromise the quality of the clinical trial
- Continued Eligibility Criteria:
- Patients must continue to meet eligibility criteria and have an average (of 3 measurements) resting LVEDP \> 18 mm Hg and resting tau \> 50 ms at time of cardiac catheterization to receive study drug.
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01163734
Start Date
April 1 2010
End Date
February 1 2011
Last Update
July 12 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University Medicine Goettingen (UMG)
Göttingen, Germany