Nutritional Interventions in Chronic Heart Failure

Last updated: January 31, 2021
Sponsor: National Taiwan University Hospital
Overall Status: Completed

Phase

N/A

Condition

Heart Failure

Chest Pain

Congestive Heart Failure

Treatment

N/A

Clinical Study ID

NCT03845309
201810039RINA
  • Ages > 20
  • All Genders

Study Summary

This study recruited patients diagnosed with heart failure by cardiologists and cardiac outpatients whose cardiac functions were graded from 1 to 4 according to the New York Heart Association as the study participants. The participants were provided active nutrition intervention including diet optimization,specific recommendations and nutritional supplement prescriptions in cases in which nutritional goals were not reached.In addition, this study offered advice by referencing lifestyle change advice provided by the American Heart Association for patients with heart failure.

The Mini Nutritional Assessment Short-Form was used to assess malnutrition indicator values. The participant water, nutrient (i.e., carbohydrates, protein, and fat), and calorie intake data were collected using their recollection of their dietary intake and food intake frequency over a 24-hour dietary recall. The amount of fluid and sodium administered was provided according to the cardiac function grades indicated by the New York Heart Association.In addition, dietary assessments and nutritional advice were offered on the basis of the patients' conditions (i.e., age, activity, and comorbidity).

Finally, instrumental activities of daily living, EQ-5D (an instrument for measuring quality of life), grip performance, and 6-minute walk test data were utilized to analyze the changes in the participants before and after intervention, identifying the correlation between using nutrition education as an intervention measure and improvement in the participants' nutritional status, quality of life, and self-care behavior.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients diagnosed with CHF by a cardiologist. Clinical patients with the functionalclassification of NYHA FcI-NYHA FcⅣ according to the New York Heart Association (NYHA).
  2. Adults aged 20 years or older who are conscious, have normal cognitive function, canwalk without assistance, and do not require breathing aids. Additionally, participantsmust be able to answer questionnaires in Mandarin Chinese or Taiwanese, either orallyor in writing.
  3. Patients who have agreed to participate in the study by completing a consent form.

Exclusion

Exclusion Criteria:

  1. Patients with an expected survival period of less than 6 months because of a diseasenot related to CHF
  2. Long-term bed-bound patients
  3. Patients with no potential for rehabilitation because of decline in functions ofneural or musculoskeletal systems
  4. Patients with severe disorders of consciousness or cognitive disorders or those withmental illness
  5. Patients who require breathing aids for an extended period of time
  6. Patients with end-stage severe CHF who have been diagnosed by doctors as unable torecover within a short period
  7. Patients who are scheduled to undergo coronary artery bypass surgery or a heart valvesurgery within 1 month
  8. Patients who are on hemodialysis or are awaiting a kidney transplant
  9. Patients with severe pulmonary diseases who require long-term home oxygen therapy
  10. Patients who themselves decline to participate or who have a family member who objectsto their participation.

Study Design

Total Participants: 95
Study Start date:
February 19, 2019
Estimated Completion Date:
December 13, 2020

Study Description

Malnutrition may be caused by decreased nutrient intake or absorption, inflammation, or other disease-related mechanisms. Malnutrition resulting from disease or injury may be caused by decreased food intake or varying degrees of acute or chronic inflammation, which alters body composit ion and prompts a decline in biological functions. The effects of decreased food intake induced by an inflammatory reaction are related to the malnourishment resulted from anorexia, changes in metabolism, increased resting energy expenditure, and increased muscle catabolism. Changes in body composition are characterized by a decrease in any muscle mass marker (excluding fat mass, muscle mass index, or body cell mass). Therefore, malnutrition is associated with clinical results of clinical malfunction.

The primary objectives of heart failure treatment include preventing the need for hospitalization, increasing the survival rate, and improving health status. Patient symptoms, bodily functions, and health status are also referred to as health-related quality of life (HRQoL). The EuroQol-5D (EQ-5D) is used to assess the quality of life of patients undergoing cardiac rehabilitation. This assessment uses 5 aspects, namely mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, to assess patient health status.

Cardiopulmonary exercise testing (CPET) is the gold standard method for evaluating the motor ability of patients with chronic heart failure (CHF), yet is not extensively used. A more commonly used and simpler method is the 6-minute walk test, which measures the distance traveled by walking for 6 minutes. Changes in this value correlate to quality of life. This test is used to investigate the ability to perform daily activities and intensity of exercise in patients with mild to moderate CHF.

Muscle strength is a key indicator for assessing patients with sarcopenia because decreased muscle strength is considered a crucial element in diagnosing muscle reduction. For circumstances in which muscle mass is difficult to assess, muscle strength, such as handgrip strength, can serve as a standard assessment of muscle functions.

Exercise training is considered a valid method for stabilizing patients with heart failure. One study reported that the self-management intervention of a patient with heart failure notably decreased the occurrence of hospitalization and hospital readmission related to heart failure as well as all-cause mortality.

The present study determines the effectiveness of nutrition intervention in routine medical treatment for improving the nutrition and quality of care among patients with heart failure.

This study does not involve drugs, medical technology, or medical equipment.

Connect with a study center

  • Department of Internal Medicine, National Taiwan Univeristy Hospital Yun-Lin branch

    Douliu, Yunlin County 640
    Taiwan

    Site Not Available

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