Ranolazine in Diastolic Heart Failure (RALI-DHF)
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ClinicalTrials.gov Identifier: NCT01163734 |
Recruitment Status
:
Completed
First Posted
: July 16, 2010
Last Update Posted
: July 12, 2012
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diastolic Heart Failure | Drug: Ranolazine Other: Saline 0.9% and placebo tablet | Phase 2 |
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 receive ranolazine or placebo in a 1.5:1 ratio (12 ranolazine: 8 placebo).
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 20 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Official Title: | A Randomized, Double-blind, Placebo-controlled Study of Ranolazine in Patients With Heart Failure With Preserved Ejection Fraction |
Study Start Date : | April 2010 |
Actual Primary Completion Date : | February 2011 |
Actual Study Completion Date : | February 2011 |

Arm | Intervention/treatment |
---|---|
Experimental: Ranolazine |
Drug: Ranolazine
Intravenous treatment followed oral treatment for 13 days.
Other Name: Ranexa
|
Placebo Comparator: Saline 0.9%
Saline 0.9% and placebo tablet
|
Other: Saline 0.9% and placebo tablet
Intravenous treatment followed by oral treatment for 13 days
Other Name: Normal Saline
|
- Change from baseline to 30 minutes in cardiac catheterization hemodynamic parameters at both resting and paced conditions [ Time Frame: Baseline to 30 minutes ]
Change from baseline to 30 minutes from initiation of study drug bolus No.1 in cardiac catheterization hemodynamic parameters at both resting and paced conditions:
Time-constant of relaxation (tau)
Left ventricular end-diastolic pressure (LVEDP)
dP/dtmin (minimal rate of LV pressure change)
- Change from baseline to Day 14 in mitral E wave velocity/mitral annular velocity (E/E') ratio [ Time Frame: Baseline to Day 14 ]
- Change from baseline to Day 14 in VO2 max [ Time Frame: Baseline to Day 14 ]
- Change from baseline to Day 14 in N-terminal pro-brain B-type natriuretic peptide (NT-pro-BNP) [ Time Frame: Baseline to Day 14 ]

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Ages Eligible for Study: | 40 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01163734
Germany | |
University Medicine Goettingen (UMG) | |
Goettingen, Germany |
Principal Investigator: | Lars S. Maier, MD | University Medicine Göttingen, Cardiac Center |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Gilead Sciences |
ClinicalTrials.gov Identifier: | NCT01163734 History of Changes |
Other Study ID Numbers: |
GS-US-270-0101 |
First Posted: | July 16, 2010 Key Record Dates |
Last Update Posted: | July 12, 2012 |
Last Verified: | March 2011 |
Keywords provided by Gilead Sciences:
Heart Failure with Preserved Ejection Fraction (HFpEF) Coronary Artery Disease (CAD) |
Additional relevant MeSH terms:
Heart Failure Heart Failure, Diastolic Heart Diseases Cardiovascular Diseases |
Ranolazine Sodium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action |