Monocentric prospective randomized controlled open phase IV study to explorate the mechanismen of the synergetic effect of the Crateagus -Extract WS® 1442 in addition to endurance training related to quality of life of patients with limited physical potential caused by cardiovascular disease (Heart Failure Stade NYHA II)

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1)male and female patients > 45 years
2)written informed consent
3)too little physical movement ( less than twice movements per week)
4)history of cardiac disease, decreasing physical potential (heart failure related to NYHA II). That is heart diesease with less limitation of physical potentail, no disorders calmly, dialy physical strain causes fatique, heart rhythm disturbances, angina pectoris or dyspnea
5)existence of at least two of the following cardiovascular riskfactors
a)smoker
b)waist circumference (female equal or more than 88 cm, male equal or more than
102 cm or BMI> 30)
c)diabetes Mellitus (blood sugar>110mg/dl or manifested diabestes mellitus
d)arterial hypertension
e)disorder of metabolism
6)willing and able to complete the trial and to take part in all trial prosedures as described in the protocol
7)female patients must ever be at least two years menopausal or have a negative serum or urin pregnancy test prior to study entry and have to use one of the following birth control methods,
hormonal contraceptives,
IUD,
lifestyle with a personal choice of abstinence,
vasectomy of sexual partner
8)unchanged basic therapy of heart failure since 4 weeks
9)at least one of the following underlying diseases:
chronic coronary heart disease
non acute non ischaemic cardiomyopathy, for example myocarditis
arterial hypertension
nomofrequent atrial fibrillation
vitium Grade 1. or 2.
condition after changing cardia velve
10) calmly LVEF > 40%
11) NT-pro-BNP < 450 ng/l
12) cardiologic medicinal basic therapy according to the guidelines of the German Society of Cardiology (Hoppe et al.) and the European Society of Cardiology (Dickstein et al.) for patients with LVEF > 40%.
Diuretics and/or Nitrate
Betareceptorblocker and/or Verapamil to lower der heart frequence
adequate treatment of the underlying disease(s)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1)acute and heavy heart failure within the last three months
2)patients with pacemaker or ICD
3)increasing worsening of the cardiology disorder within the last 7 days
4)intake of any hawthorn compound or of any other herbal compound for heart-active compund
5)acute or chronic psychiatric disorder
6)history of drug allergy or hypersensitivity to drug ingredients
7)subjects should not be enrolled as a participant in any other clinical tria within the last 4 weeks
8)pregnant or lactating women
9)patients positive tested for acute and heavy prohibited drugs of abuse (alcohol drugs)
10)patients, who are planning a hospitalization during the course of the study
11)subjects who are otherwise unsuitable for the participation in this trial in the opinion (not speaking german, acute pysical exposure, patient not able to understand the importance, consequence and the nature of the trial)
12) treatment with heart-active glycosoide
13)heavy or acute general disease within the last 4 weeks
14) atrial fibrillation

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Related Trials