Clinical trial NCT01581034: Effect of PADMA 28 on Endothelial Function, Autonomic Nervous System and Biomarkers in Patients With Coronary Artery Disease
Official title: A Randomized, Placebo-controlled, Double-blinded Trial on the Effect of PADMA 28 on Endothelial Function, Biomarkers and the Autonomic Nervous System in Patients With Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Coronary Artery Disease
Keywords: endothelial function
biomarkers
autonomic nervous system
coronary artery disease
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2012-04-19
Enrollment: 80
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This randomized, placebo-controlled, double-blinded trial investigates the effect of a 6 week intake of PADMA 28 on the endothelial function, biomarkers and the autonomic nervous systems in patients with coronary artery disease. The investigators hypothesize that PADMA 28 has a beneficial effect on endothelial function, arterial stiffness, the autonomic nervous systen and the blood inflammatory markers in patients with coronary artery disease compared to placebo treatment.

Detailed description: Background

This randomized, placebo-controlled, double-blinded trial investigates the effect of a 6 week intake of PADMA 28 on the endothelial function, biomarkers and the autonomic nervous systems in patients with coronary artery disease. PADMA 28 contains 20 herbs from Tibet. The endothelial function will be measured by EndoPAT 2000, the autonomic nervous system by an ambulatory electrocardiography during the orthostatic reaction and the biomarkers will be analyzed with taking a blood sample. The investigators hypothesize that PADMA 28 has a beneficial effect on endothelial function, arterial stiffness, the autonomic nervous systen and the blood inflammatory markers in patients with coronary artery disease compared to placebo treatment.

Objective

To assess the effect of PADMA 28 on endothelial function, autonomic nervous system and biomarkers in patients with coronary artery disease.

Methods

80 patients with coronary artery disease will be recruited for the study. To measure endothelial function, the investigators use EndoPAT 2000. The autonomic nervous system will be analysed with ambulatory electrocardiography.

Eligibility criteria: Inclusion Criteria:

* Male patient with coronary artery disease
* Stable medication
* Physically stable
* Psychologically stable
* Written informed consent
* Willing and able to comply with all trial requirements
* Must have completed rehabilitation program since at least 6 months and no longer than 5 years prior to study begin

Exclusion Criteria:

* Acute coronary syndrome within the last three months
* Abnormal high hepatic enzymes
* Renal insufficiency with compensated retention
* Intake of medication which may affect endothelial function
* Currently smoking
* Current malignant diseases, which may reduce the expectancy of life
* Chronic heart failure
* Insulin-dependent diabetes
* Known hypersensitivity against any ingredient of PADMA 28
* Longterm intake of supplements
* Serious mental health issues
* Alcohol and/or drug abuse
* Simultaneous participation in another clinical trial

Primary outcomes:
measure: Endothelial function
timeFrame: At completion of the study, expected to be at 6 weeks
Secondary outcomes:
measure: Autonomic nervous system
timeFrame: At completion of the study, expected to be at 6 weeks
measure: Biomarkers in blood
timeFrame: At completion of the study, expected to be at 6 weeks
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Swiss Cardiovascular Prevention and Rehabilitation Center, Bern University Hospital
Study officials:
affiliation: Department of cardiovascular prevention and rehabilitation, Bern University Hospital
name: Hugo Saner, Prof. Dr.
role: STUDY_CHAIR
References:
citation: Schafer D, Lambrecht J, Radtke T, Wilhelm M, Saner H. Effect of a Tibetan herbal mixture on microvascular endothelial function, heart rate variability and biomarkers of inflammation, clotting and coagulation. Eur J Prev Cardiol. 2015 Aug;22(8):1043-5. doi: 10.1177/2047487314544985. Epub 2014 Sep 10.