NCT00538941

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable heart-failure

Timeline
Completed

Started Nov 2005

Typical duration for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

October 1, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 3, 2007

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

October 28, 2009

Status Verified

October 1, 2009

Enrollment Period

3.9 years

First QC Date

October 1, 2007

Last Update Submit

October 27, 2009

Conditions

Heart Failure

Keywords

chocolate,heart failure,endothelial function,platelet adhesion,oxidative stress,baroreceptor function,

Outcome Measures

Primary Outcomes (1)

  • endothelial function

    acute (2 hours), chronic (2 and 4 weeks)

Secondary Outcomes (1)

  • 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)

Study Arms (2)

1

ACTIVE COMPARATOR

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

Dietary Supplement: Nestlé Noir intense 40 grx2

2

PLACEBO COMPARATOR

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

Dietary Supplement: Nestlé Placebo Chocolate 40 grx2

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.

1
Nestlé Placebo Chocolate 40 grx2DIETARY_SUPPLEMENT

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

2

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Heart failure ( NYHA ≥II, LVEF\<50%, independent of aetiology)
  • Nonsmokers
  • Age: 30-80
  • Written obtained informed consent

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiovascular Center, Cardiology, University Hospital of Zurich

Zurich, 8091, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 22173910DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Georg Noll, MD

    Cardiovascular Center, University Hospital Zurich, Zurich, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 1, 2007

First Posted

October 3, 2007

Study Start

November 1, 2005

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

October 28, 2009

Record last verified: 2009-10

Locations

CH(1)