Effects of Chocolate in Patients With Chronic Heart Failure

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00538941
• Other study ID #: EK1124_Chocolate_CHF
• Status: Completed
• Phase: N/A
• First received: October 1, 2007
• Last updated: October 27, 2009
• Start date: November 2005
• Est. completion date: October 2009

Study information

• Verified date: October 2009
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: EthikkommissionSwitzerland: Swissmedic
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure

Intervention

Dietary Supplement:
• Nestlé Noir intense 40 grx2
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 grx2
Nestlé Placebo Chocolate 40 gr in the morning and 40gr chocolate in the evening.

Locations

Country	Name	City	State
Switzerland	Cardiovascular Center, Cardiology, University Hospital of Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	endothelial function		acute (2 hours), chronic (2 and 4 weeks)	No
Secondary	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)	No