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Slowing HEART diSease With Lifestyle and Omega-3 Fatty Acids (HEARTS)

26 de septiembre de 2017 actualizado por: Francine K. Welty, Beth Israel Deaconess Medical Center

Slowing HEART diSease With Lifestyle and Omega-3 Fatty Acids (HEARTS)

The purpose of the study is to target inflammation to reduce progression of noncalcified plaque in the coronary arteries using omega-3 fatty acid supplementation compared to standard of care.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

Study Design: This is a randomized, parallel study design with a usual care control group. 278 subjects with coronary heart disease (CHD) are being randomized to omega-3 supplementation or standard of care (139 in each arm).

Multidetector computed tomographic angiography (MDCTA) is performed at baseline to quantitate the amount of noncalcified and calcified coronary plaque and again at 30 month follow-up to determine if there has been a change in the volume of noncalcified or total plaque. The primary endpoint is change in coronary noncalcified plaque volume during the 30 months of intervention between active and standard of care.

Hypothesis: Percent change in progression of coronary plaque volume will be less for the omega-3 fatty acid intervention compared to standard of care.

Secondary endpoints include plasma levels of inflammatory markers, lipids and measures of insulin sensitivity.

Secondary outcomes include testing the hypothesis that targeting inflammation with omega-3 fatty acids will be associated with:

  1. Change in total plaque volume per patient.
  2. improvement in physical function and exercise and reduction in pain and stiffness as measured by the WOMAC questionnaire
  3. Reduction of mediators of inflammation in the circulation including CRP, PAI-1, serum amyloid A, MMP-9 and fibrinogen, pro-inflammatory cytokines including IL-6, TNF-a and IL-1b, the adhesion molecules VCAM-1 and ICAM-1, increase in adiponectin and reduction in serum nitrotyrosine as a marker of oxidative stress.
  4. Reduction of insulin resistance assessed by fasting insulin and homeostasis model assessment of insulin resistance (HOMA-IR).
  5. Reduction of inflammation in the liver associated with nonalcoholic steatohepatitis (NASH), a newly recognized component of the metabolic syndrome, and reduction of fatty liver quantitated by computerized tomography and levels of AST and ALT as markers of liver inflammation related to NASH.
  6. Investigation of the relationship between vitamin D status and coronary plaque progression as well as with insulin resistance (HOMA-IR), beta-cell function (HOMA-%beta) and inflammatory cytokines.
  7. Determination of whether baseline vitamin D levels predict clinical response to the omega-3 fatty acid intervention, and whether hypovitaminosis D is associated with plaque progression.

Tipo de estudio

Intervencionista

Inscripción (Actual)

338

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Estados Unidos
    • Massachusetts
      • Boston, Massachusetts, Estados Unidos, 02215
        • Beth Israel Deaconess Medical Center
      • Milton, Massachusetts, Estados Unidos, 02186
        • South Shore Medical Group

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

21 años a 80 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  1. coronary artery disease
  2. previous myocardial infarction
  3. angioplasty (> 6 months ago)
  4. previous coronary bypass surgery (> 12 months ago)
  5. stable angina
  6. non-calcified plaque on prior CT
  7. abnormal exercise tolerance test
  8. aged 21- 80 years
  9. BMI ≥ 27 kg/m2 and ≤ 35 kg/m2 if female and ≤ 40 kg/m2 if male (a BMI > 24.5 for subjects from Asian origin)
  10. stable dose of statin for 1 month at screening or unable to tolerate a statin
  11. normal renal function - estimated creatinine clearance calculated using Cockcroft-Gault (CG) equation ≥60 at screening [eCrCLCG (ml/min) = [(140 - age) x weight (kg)]/[SCr(mg/dl) x 72] x [0.85 if female] or serum Cr < 1.3
  12. ALT, AST) < 3 times upper limits of normal)
  13. normal thyroid function or on stable dose replacement therapy
  14. an ETT performed within 12 months prior

Exclusion criteria

  1. unstable angina (increase in frequency or severity of anginal episodes or development of chest pain at rest)
  2. significant obstructive disease in left main coronary artery, ostial LAD or newly diagnosed three-vessel disease since prior cardiac catheterization by MDCTA
  3. significant heart failure (NYHA class III and IV)
  4. Current atrial fibrillation or Wolf-Parkinson-White (WPW) syndrome
  5. allergy to beta-blocker in subjects with resting heart rate > 65 bpm
  6. systolic blood pressure > 160 mm Hg
  7. diastolic BP > 100 mm Hg
  8. persons with allergies to iodinated contrast material or shellfish
  9. allergy to nitroglycerin
  10. history of asthma only if unable to tolerate beta-blockers
  11. BMI > 35 kg/m2 if female and > 40 kg/m2 if male
  12. body weight > 350 lbs
  13. Use of drugs for weight loss [eg Xenical (orlistat), Meridia (sibutramine), Acutrim (phenylpropanolamine) or similar over-the-counter medications] within three months of screening
  14. surgery within 30 days of screening
  15. history of acquired immune deficiency syndrome or human immunodeficiency virus (HIV)
  16. poor mental function or history of dementia/Alzheimer's Disease or on medications used for treatment of dementia [e.g. Tacrine (Cognex), Rivastigmine (Exelon), Galantamine (Razadyne, Reminyl), Donepezil (Aricept), Memantine (Namenda)] or any other reason to except patient difficulty in complying with the requirements of the study
  17. medicine for erectile dysfunction within 72 hours prior to MDCTA
  18. Prior stroke with residual cognitive deficit or functional deficit preventing any type of exercise
  19. Current chemotherapy or radiation for malignancy
  20. Current weekly alcohol consumption > 21 units/week (1 unit = 1 beer, 1 glass of wine, 1 mixed cocktail containing 1 ounce of alcohol)

Exclusions based on nuclear imaging:

  1. Transient cavity dilation
  2. More than one vascular territory involved with reversible defect (multiple defects)
  3. Reversible defects involving the anterior wall, septum or apex (LAD territory)

Exclusions based on echocardiography imaging:

1. More than one vascular territory involved with inducible wall motion abnormalities (multiple defects) 2. Inducible wall motion abnormalities involving the anterior wall, septum or apex (LAD territory)

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Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Sin intervención: Usual care
Those randomized to usual care will continue to follow the care provided by their cardiologist. They will have all the follow-up phone calls, visits and testing which the intervention group has.
Comparador activo: Lovaza (Omega 3 ethyl esters)
Suplemento dietético: Omega 3 acid ethyl esters
Lovaza 3.6 g daily

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
The primary endpoint is change in coronary noncalcified plaque volume.
Periodo de tiempo: Baseline and 30 months
MDCTA is performed at baseline to quantitate the amount of noncalcified and calcified coronary plaque and again at 30 month follow-up to determine if there has been a change in the volume of noncalcified or total plaque. The primary endpoint is change in coronary noncalcified plaque volume during the 30 months of intervention between active and standard of care. The hypothesis is that those on Lovaza will have less progression of coronary plaque compared to those in usual care.
Baseline and 30 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Coronary artery plaque assessment
Periodo de tiempo: Baseline and 30 months
  1. Percent atheroma volume calculated as the proportion of the entire vessel wall occupied by atherosclerotic plaque and total atheroma volume, normalized to segment length.
  2. Maximum percent diameter stenosis and minimal luminal diameter.
  3. Number of subjects with categorical variables of maximal stenosis >50% and number with 3-vessel disease >20%.
  4. Number of subjects with stenosis of 0-29%, 30-49%, 50-69% and >70% stenosis at baseline compared to 30 months.
  5. Change in remodeling index - ratio of plaque volume at the most diseased site compared to the least diseased site.
Baseline and 30 months
Effect of Lovaza on Physical Function, Pain, Stiffness and Exercise
Periodo de tiempo: Baseline and 1 year
Those on Lovaza will have better physical function and less pain and stiffness as assessed by the WOMAC questionnaire and more minutes of exercise per week compared to control
Baseline and 1 year
Inflammatory markers
Periodo de tiempo: Baseline and 30 months
Compared to usual care, those on Lovaza will have reduction of mediators of inflammation in the circulation, including CRP, PAI-1, serum amyloid A, MMP-9 and fibrinogen, pro-inflammatory cytokines including IL-6, TNF-a and IL-1b, the adhesion molecules VCAM-1 and ICAM-1, increase in adiponectin and reduction in serum nitrotyrosine as a marker of oxidative stress. Additional inflammatory markers may be identified in the future and measured.
Baseline and 30 months
Pericardial Fat
Periodo de tiempo: Baseline and 30 months
The amount of pericardial fat will be quantitated by CT at baseline and 30-month follow-up. The percent change between the two time-frames will be measured. Those on Lovaza and/or those who have lost weight will have a reduction (or lack of increase) in pericardial fat at 30-months compared to those in usual care.
Baseline and 30 months
Insulin Resistance
Periodo de tiempo: Baseline and 30 months
Insulin resistance will be assessed by fasting insulin and homeostasis model assessment of insulin resistance (HOMA-IR) at baseline and 30-months in the two study groups.
Baseline and 30 months
Nonalcoholic steatohepatitis (NASH)
Periodo de tiempo: Baseline and 30 months
Reduction of inflammation in the liver associated with nonalcoholic steatohepatitis (NASH), a component of the metabolic syndrome, and reduction of fatty liver quantitated by computerized tomography and levels of AST and ALT as markers of liver inflammation related to NASH.
Baseline and 30 months
Vitamin D Levels and coronary plaque progression
Periodo de tiempo: Baseline and 30 months
  1. Investigation of the relationship between vitamin D status and coronary plaque progression, insulin resistance (HOMA-IR), beta-cell function (HOMA-%beta) and inflammatory cytokines
  2. Do baseline vitamin D levels predict response to omega-3 fatty acid supplementation?
Baseline and 30 months
Cognitive function
Periodo de tiempo: Baseline, 1 year and 30-months
To determine if those on Lovaza have less decline in cognitive function at 1 year and 30 months of follow-up compared to those in the usual care group.
Baseline, 1 year and 30-months
Exercise capacity and coronary plaque
Periodo de tiempo: Baseline
To determine if exercise capacity correlates with coronary plaque measurements. The hypothesis is that those with better exercise capacity will have lower amounts of coronary plaque.
Baseline
Urinary microalbumin and coronary plaque
Periodo de tiempo: Baseline and 30-months
At baseline, subjects with lower urinary microalbumin will have lower amounts of coronary plaque. Those taking Lovaza will have less increase in urinary microalbmumin at 30-month follow-up compared to those in usual care.
Baseline and 30-months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Beth Israel Deaconess Medical Center

Colaboradores

National Heart, Lung, and Blood Institute (NHLBI)
Tufts Medical Center

Investigadores

  • Investigador principal: Francine K Welty, MD, PhD, Beth Israel Deaconess Medical Center

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de junio de 2009

Finalización primaria (Actual)

15 de enero de 2015

Finalización del estudio (Actual)

15 de enero de 2015

Fechas de registro del estudio

Enviado por primera vez

15 de mayo de 2012

Primero enviado que cumplió con los criterios de control de calidad

19 de junio de 2012

Publicado por primera vez (Estimar)

21 de junio de 2012

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

27 de septiembre de 2017

Última actualización enviada que cumplió con los criterios de control de calidad

26 de septiembre de 2017

Última verificación

1 de septiembre de 2017

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 2006P000175
  • P50HL083813 (NIH)

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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