NCT03845309

Nutritional Interventions in Chronic Heart Failure

Completed NA Last updated 2 February 2021

What this trial tests

NA trial testing Self-Care Behavior in Chronic Heart Failure in 95 participants. Completed in 13 December 2020.

Timeline

19 February 2019

Primary endpoint
13 December 2020

13 December 2020

Quick facts

Lead sponsor	National Taiwan University Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	supportive care
Enrollment	95
Start date	19 February 2019
Primary completion	13 December 2020
Estimated completion	13 December 2020
Sites	1 location across Taiwan

Drugs / interventions tested

• Self-Care Behavior

Conditions studied

• Chronic Heart Failure — all drugs for Chronic Heart Failure →
• Nutrition — all drugs for Nutrition →

Sponsor

National Taiwan University Hospital

Who can join

20 and older, any sex, with Chronic Heart Failure or Nutrition. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Innovation in Ambulatory Care of Heart Failure in the Era of Coronavirus Disease 2019.
   Leiva O, Bhatt AS, Vaduganathan M. · · 2020 · cited 5× · PMID 32888638 · DOI 10.1016/j.hfc.2020.06.004