Clinical trial NCT00538941: Effects of Chocolate in Patients With Chronic Heart Failure
Official title: Effects of Swiss Dark Chocolate on Endothelial and Baroreceptor Function and Markers of Inflammation in Patients With Chronic Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: chocolate,
heart failure,
endothelial function,
platelet adhesion,
oxidative stress,
baroreceptor function,
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2007-10-03
Enrollment: 22
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: endothelial function
timeFrame: acute (2 hours), chronic (2 and 4 weeks)
Secondary outcomes:
measure: 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.
timeFrame: acute (2 hours), chronic (2 and 4 weeks)
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Cardiovascular Center, Cardiology, University Hospital of Zurich
Study officials:
affiliation: Cardiovascular Center, University Hospital Zurich, Zurich, Switzerland
name: Georg Noll, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Flammer AJ, Sudano I, Wolfrum M, Thomas R, Enseleit F, Periat D, Kaiser P, Hirt A, Hermann M, Serafini M, Leveques A, Luscher TF, Ruschitzka F, Noll G, Corti R. Cardiovascular effects of flavanol-rich chocolate in patients with heart failure. Eur Heart J. 2012 Sep;33(17):2172-80. doi: 10.1093/eurheartj/ehr448. Epub 2011 Dec 15.