Effects of Chocolate in Patients With Chronic Heart Failure

University of Zurich22 enrolled

Overview

The aim of the present study is to investigate whether in patients with chronic heart failure endothelial dysfunction and baroreceptor function is altered by ingestion of a flavonoid-rich dark chocolate in comparison to placebo chocolate (Nestlé Placebo Chocolate) on top of standard medication. Moreover, we will evaluate the effect of chocolate on oxidative stress, platelet adhesion as well as systemic inflammatory response such as C-reactive protein and pro-inflammatory cytokines in patients with chronic heart failure.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Heart Failure

Interventions

Nestlé Noir intense 40 grx2DIETARY_SUPPLEMENT

daily intake of 40gr chocolate (Nestlé Noir intense or Nestlé Placebo Chocolate) in the morning and 40gr chocolate in the evening.

Nestlé Placebo Chocolate 40 grx2DIETARY_SUPPLEMENT

Nestlé Placebo Chocolate 40 gr in the morning and 40gr chocolate in the evening.

Eligibility

Sex: ALLMin age: 30 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Heart failure ( NYHA ≥II, LVEF\<50%, independent of aetiology) 2. Nonsmokers 3. Age: 30-80 4. Written obtained informed consent Exclusion Criteria: 1. Decompensated Heart failure 2. Instable Angina pectoris 3. Smokers 4. Ventricular tachyarrhythmias or AV-Block \>I° 5. Renal failure (\>200 umol) 6. Liver disease (ALT or AST \>150 IU) 7. Diabetes mellitus 8. Obesity (BMI \>30 kg/m2) 9. Symptomatic hypotension, hypertension \>160/100mmHg 10. Known allergy to compounds of Nestlé noir intense 11. History of gastric ulcer or bleeding, current diarrhea 12. Venous thrombosis or pulmonary embolism, at present or recurrent history of Infectious disease, acutely or chronic 13. Disease with systemic inflammation (e.g. rheumatoid arthritis, M. Crohn) 14. Neoplasia (unless healed or remission \>5 years) 15. Participation in another study within the last month 16. Concomitant vitamin supplements

Locations (1)

Cardiovascular Center, Cardiology, University Hospital of Zurich

Zurich, Switzerland

Outcomes

Primary Outcomes

endothelial function

Time frame: acute (2 hours), chronic (2 and 4 weeks)

Secondary Outcomes

shear-stress dependent platelet function; Oxidative stress; baroreceptor function Systemic inflammatory response (assessed as change in high sensitivity CRP, 8-Isoprostanes, CD-40 ligand); Plasma epicatechins.

Time frame: acute (2 hours), chronic (2 and 4 weeks)

Data from ClinicalTrials.gov

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