heart failure, stage NYHA II MedDRA version: 12.0 Level: LLT Classification code 10019279 Term:
Conditions
Interventions
Trade Name: Crataegutt® novo 450 film coated tablets
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Crateagus lavigata-Extract
Current Sponsor code: WS® 1442
Concentration unit: mg milli
Sponsors
Dr. Willmar Schwabe GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
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 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1)the main objective of the study is to evaluate the physical mechanismn, which will caused by giving Crataegus-Extract WS® 1442 to patients having heart failure NYHA II, who are graduating a moderate endurance training. Those physical mechanismn will raise in addition to endurance training the quality of life 2)to identify the parameters, which will captured the physical mechanismn definitely 3)to verify the efficacy of Crataegus-Extract Ws 1442 with regard to life quality, physical potential and parameters, which will capture functions of the cardiopulmonary vascular and muscular systems 4)to evaluate the compatibility;Secondary Objective: ;Primary end point(s): quality of life, engaged by the Cansas City Cardioyopathy Questionaire (KCCQ) physical potential in daily life, efficiency tests during maximum of impact as well as every day stresses Efficiency of muscle work cardiac output during impact cardiovascular functions during impact oxygen supply of muscles unexpexted adverse events | — |
Countries
Germany
Outcome results
None listed