Effects of Chocolate in Patients With Chronic Heart Failure

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Swiss Dark Chocolate on Endothelial and Baroreceptor Function and Markers of Inflammation in Patients With Chronic Heart Failure

Conditions
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Heart Failure

Intervention / Treatment
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* Dietary Supplement: Nestlé Noir intense 40 grx2
* Dietary Supplement: Nestlé Placebo Chocolate 40 grx2


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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>daily intake of 40gr chocolate (Nestlé Noir intense) in the morning and 40gr chocolate in the evening. | Dietary Supplement: Nestlé Noir intense 40 grx2<br>* daily intake of 40gr chocolate (Nestlé Noir intense or Nestlé Placebo Chocolate) in the morning and 40gr chocolate in the evening.<br>|
| Placebo Comparator: 2<br>Nestlé Placebo Chocolate 40gr in the morning and 40gr chocolate in the evening. | Dietary Supplement: Nestlé Placebo Chocolate 40 grx2<br>* Nestlé Placebo Chocolate 40 gr in the morning and 40gr chocolate in the evening.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| endothelial function |  | acute (2 hours), chronic (2 and 4 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | acute (2 hours), chronic (2 and 4 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chocolate,, heart failure,, endothelial function,, platelet adhesion,, oxidative stress,, baroreceptor function,