Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
20 participants
INTERVENTIONAL
2010-04-30
2011-02-28
Brief Summary
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Detailed Description
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Treatment will consist of intravenous infusion of study drug followed by oral treatment for a total of 14 days treatment period. Study contact will be made approximately 14 days after the treatment period to assess safety.
Cardiac catheterization will be performed for LV pressures and hemodynamic measurements before and after drug administration. Doppler ECHO, CPET, and NT-pro-BNP determination will be performed at screening and at end of study. Adverse events and safety labs will be monitored and collected.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
DOUBLE
Study Groups
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Ranolazine
Ranolazine
Intravenous treatment followed oral treatment for 13 days.
Saline 0.9%
Saline 0.9% and placebo tablet
Saline 0.9% and placebo tablet
Intravenous treatment followed by oral treatment for 13 days
Interventions
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Ranolazine
Intravenous treatment followed oral treatment for 13 days.
Saline 0.9% and placebo tablet
Intravenous treatment followed by oral treatment for 13 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Clinical symptoms of heart failure (NYHA class II-III) at time of screening (e.g., dyspnea, paroxysmal nocturnal dyspnea, orthopnea, bilateral lower extremity edema)
3. Left ventricular ejection fraction (LVEF) \> 45% at screening
4. 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)
5. Signed informed consent
Exclusion Criteria
2. Hypotension with blood pressure \< 90/50 mm Hg
3. Primary hypertrophic or restrictive cardiomyopathy or systemic illness associated with infiltrative heart disease (e.g., cardiac amyloidosis)
4. Pericardial constriction
5. Hemodynamically significant uncorrected obstructive or regurgitant valvular disease
6. Cor pulmonale or other causes of right heart failure not associated with left ventricular dysfunction
7. Clinically significant pulmonary disease in the opinion of the Investigator or requiring home oxygen or oral steroid therapy
8. History of serious cardiac dysrrhythmias including atrial fibrillation with resting heart rate of \> 100 beats per minute
9. Need for treatment with Class I or III antiarrhythmic medications
10. Implantable pacemaker, cardioverter-defibrillator, or left ventricular assist device
11. Clinically significant chronic hepatic impairment (Child-Pugh Class B \[moderate\] or Class C \[severe\])
12. Severe renal insufficiency defined as creatinine clearance ≤30 mL/min as calculated by Cockcroft-Gault formula or Modified Diet in Renal Disease (MDRD) equation.
13. History of congenital or a family history of long QT syndrome, or known acquired QT interval prolongation
14. Inability to exercise due to other co-morbidities that may affect performance of cardiopulmonary exercise test (CPET) (e.g., osteoarthritis, peripheral vascular disease)
15. Current treatment with potent and moderate CYP3A inhibitors
16. Current treatment with potent CYP3A inducers (e.g., rifampin/rifampicin, St. John's Wort, carbamazepin/carbamazepine)
17. Prior treatment with ranolazine
18. 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.
40 Years
ALL
No
Sponsors
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University Medicine Göttingen, Cardiac Center
UNKNOWN
Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Lars S. Maier, MD
Role: PRINCIPAL_INVESTIGATOR
University Medicine Göttingen, Cardiac Center
Locations
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University Medicine Goettingen (UMG)
Göttingen, , Germany
Countries
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References
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Maier LS, Layug B, Karwatowska-Prokopczuk E, Belardinelli L, Lee S, Sander J, Lang C, Wachter R, Edelmann F, Hasenfuss G, Jacobshagen C. RAnoLazIne for the treatment of diastolic heart failure in patients with preserved ejection fraction: the RALI-DHF proof-of-concept study. JACC Heart Fail. 2013 Apr;1(2):115-22. doi: 10.1016/j.jchf.2012.12.002. Epub 2013 Apr 1.
Jacobshagen C, Belardinelli L, Hasenfuss G, Maier LS. Ranolazine for the treatment of heart failure with preserved ejection fraction: background, aims, and design of the RALI-DHF study. Clin Cardiol. 2011 Jul;34(7):426-32. doi: 10.1002/clc.20897. Epub 2011 Apr 27.
Other Identifiers
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GS-US-270-0101
Identifier Type: -
Identifier Source: org_study_id