Ranolazine in Ischemic Cardiomyopathy

NCT01345188 | Completed Phase 4 Results DMC

• 1 other identifier: IN-US-259-D032
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with ischemic cardiomyopathy may continue to experience persistent chest pain and shortness of breath despite conventional medical therapy and/or revascularization. The purpose of this study is to determine the efficacy of taking Ranexa versus placebo in patients with ischemic (due to blockages) cardiomyopathy treated with optimal conventional medical therapy and/or percutaneous revascularization.

Conditions

Cardiomyopathy; Chest Pain; Dyspnea

Outcome Measures

Primary Outcomes (3)

• Anginal Frequency

  Anginal frequency as assessed by Seattle Angina Questionnaire. Scoring is done by assessing responses on an ordinal value. Anginal score is scored by the patient by selecting a number from 0 to 100 with low score indicates more anginal frequency. The mean of the the scores of all patients analyzed were compared between placebo and Ranolazine.

  12 weeks

• Quality of Life Questionnaire

  Quality of life as measured by the Seattle Angina Questionnaire as a score ranging from 0 to 100. Higher score indicates better quality of life. The Qaulity of life is scored by the patient. It assesses the perceived satisfaction or dissatisfaction in the major domains of life. These include mobility, self-care, Usual activities (leisure, work, family), Pain/Discomfort, and Anxiety.

  12 weeks

• Dyspnea Assessed by the Rose Dyspnea Questionnaire (RDQ)

  RDQ is a four item questionnaire that evaluates a patient's dyspnea with regular activity. Each question answered postiviely is given a score of 1. Total score possible is 4. A higher score indicates worse dyspnea. A difference between the score at end of treatment minus baseline is performed. A negative score indicates improvement. Comparing the difference between the 2 arms (placebo and ranolazine) is performed.

  12 weeks

Study Arms (2)

Ranolazine

ACTIVE COMPARATOR

1000 mg Ranexa orally once daily titrated as tolerated after 1 week up to taking 1000 mg twice daily.

Drug: Ranexa

Placebo

PLACEBO COMPARATOR

1000 mg placebo orally once daily titrated as tolerated after 1 week up to taking 1000 mg twice daily.

Drug: Placebo

Interventions

Ranexa DRUG

1000 mg Ranexa orally once daily titrated as tolerated after 1 week up to taking 1000 mg twice daily.

Also known as: Ranolazine

Ranolazine

Placebo DRUG

1000 mg placebo orally once daily titrated as tolerated after 1 week up to taking 1000 mg twice daily.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ischemic cardiomyopathy patients on optimal medical treatment. Optimal medical treatment is defined as the continued symptoms of chest pain or dyspnea despite treatment with 2 antiischemic agents (beta blockers, CCB or nitrates). Unless contraindicated, all cardiomyopathy patients should be treated with a beta blocker and an ACEI/ARB.
• Anginal chest pain or dyspnea
• Documentation of non treatable or optimally treated coronary artery disease
• Ejection Fraction of less than or equal to 40%

You may not qualify if:

• Less than 18 years of age
• Pregnant or breast feeding
• Patients with non ischemic cardiomyopathy

Sponsors & Collaborators

• Midwest Cardiovascular Research Foundation: lead
• Gilead Sciences: collaborator

Study Sites (1)

Midwest Cardiovascular Research Foundation

Davenport, Iowa, 52803, United States

Location

MeSH Terms

Conditions

Cardiomyopathies; Chest Pain; Dyspnea

Interventions

Ranolazine

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr Nicolas W Shammas
• Organization: Midwest Cardiovascular Research Foundation

shammas@mchsi.com

5633242828

Study Officials

• Nicolas W Shammas, MD

  Midwest Cardiovascular Research Foundation

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, MD

Study Record Dates

• First Submitted: April 28, 2011
• First Posted: April 29, 2011
• Study Start: April 1, 2011
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: December 9, 2024
• Results First Posted: September 6, 2018

Record last verified: 2024-11

Locations

US (1)