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Diastolic Heart FailurePhase 2RALI-DHFNCT01163734

Ranolazine in Diastolic Heart Failure

A Phase 2 study testing Ranolazine in people with Diastolic Heart Failure, run by Gilead Sciences at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 infusion followed by oral treatment for 13 days. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Diastolic Heart Failure
What is being tested?
Ranolazine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
20 participants
Where
1 siteGermany
Study dates
Apr 2010to Feb 2011
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • University Medicine Goettingen (UMG)

    Göttingen

Other trials in Germany

About this study

Official title: A Randomized, Double-blind, Placebo-controlled Study of Ranolazine in Patients With Heart Failure With Preserved Ejection Fraction

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 infusion followed by oral treatment for 13 days. LV pressures and hemodynamic data will be measured prior to and after administration of study drug. In addition, Doppler ECHO, cardiopulmonary exercise testing (CPET), and NT-pro-BNP determination will be performed. Adverse events and safety labs will be collected and monitored.

Read the 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 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.

Being tested
Ranolazine, Saline 0.9% and placebo tablet
Keywords
Heart Failure with Preserved Ejection Fraction (HFpEF), Coronary Artery Disease (CAD)
Medical subject headings
Heart Failure, Diastolic, Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RanolazineDrug

    Also called Ranexa

    Intravenous treatment followed oral treatment for 13 days.

  • Saline 0.9% and placebo tabletOther

    Also called Normal Saline

    Intravenous treatment followed by oral treatment for 13 days

Study groups in NCT01163734
Study groupRoleWhat they receive
RanolazineExperimentalNot described
Receives: Drug: Ranolazine
Saline 0.9%Placebo comparatorSaline 0.9% and placebo tablet
Receives: Other: Saline 0.9% and placebo tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline to 30 minutes in cardiac catheterization hemodynamic parameters at both resting and paced conditions

    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)

    Measured: Baseline to 30 minutes

Secondary outcomes (3)

  1. Change from baseline to Day 14 in mitral E wave velocity/mitral annular velocity (E/E') ratio

    Measured: Baseline to Day 14

  2. Change from baseline to Day 14 in VO2 max

    Measured: Baseline to Day 14

  3. Change from baseline to Day 14 in N-terminal pro-brain B-type natriuretic peptide (NT-pro-BNP)

    Measured: Baseline to Day 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2010 (estimated)
  2. Study startApr 2010
  3. Primary completionFeb 2011
  4. Study completionFeb 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01163734
Sponsor's protocol ID
GS-US-270-0101
Acronym
RALI-DHF
Status last verified
Mar 2011
First submitted
12 Jul 2010
Last updated
12 Jul 2012
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 24621836

  • 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.

    PubMed 21538388

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ranolazine in people with Diastolic Heart Failure, run by Gilead Sciences at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline to 30 minutes in cardiac catheterization hemodynamic parameters at both resting and paced conditions (time frame: Baseline to 30 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01163734, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2012; AzTrials last refreshed its copy on 26 Oct 2026.

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