Randomized controlled trial on the efficacy of bloodletting for arterial hypertensio
- Conditions
- I10.0
- Registration Number
- DRKS00004265
- Lead Sponsor
- Immanuel Krankenhaus Berlin WannseeHochschulambulanz für Naturheilkunde der Charité Universitätsmedizin Abteilung für Naturheilkunde
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 60
between 30 and 70 years of age;
- manifest arterial hypertension, NICE/WHO stadium I (= 140-159 mmHg syst. and 90-99mmHg diast.) that hasn't been treated pharmacologically yet;
- Patients in Stadium II (= 160-179 mmHg syst. and 100-109 mmHg diast.) can only be included if they reject pharmacologic therapy because of intolerances to drugs (twofoldly documented in specialist-consultation by cardiologist or nephrologist).
- demonstrably elevated cardiovascular risk with prevalence of at least one of the following 4 risk factors: 1) known coronary heart disease 2) renal insufficiency with microalbuminuria (precluded by laboratory-analysis) 3) known diabetes mellitus 4) known retinopathy;
- elevated cerebrovascular risk with 1) known stenosis of common carotid artery, or anamnesis with 2) transient ischemic attack or 3) cerebral infarction
- consisting coagulation disorder, known hemophilia or pharmacological anticoagulants;
- pregnancy
- patients with acute infections
- patients with consisting anemia
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Alteration of the 24-hour bloodpressure measurement (24h-average), baseline vs. termination after 8 weeks
- Secondary Outcome Measures
Name Time Method Systolic bloodpressure after resting-period (average of 3 measurements), <br>diastolic bloodpressure after resting-period (average of 3 measurements), <br>heart rate after resting-period (average of 3 measurements), <br>blood lipids / cardiovascular risk markers: <br>1. serum ferritin, <br>2. hematocrit, <br>3. serum iron, <br>4. triglycerides, <br>5. LDL cholesterol, <br>6. HDL cholesterol; <br>baseline vs. termination after 8 weeks