German Clinical Trials Register

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Brief summary in lay language

There is a need for effective therapy on high blood pressure without medication. The aim of this study is to ascertain if blood-letting can induce the reduction of blood pressure levels and other risk factors in patients with high blood pressure. The study continues during a period of 8 weeks with a total of 60 patients. Only half of them will receive blood-letting-therapy. The other half will serve as a control-group and will be offered free-of-charge access to blood-letting-therapy after the termination of the study. At the beginning and at the end of the study there will be an ambulatory 24-hour blood pressure measurement. Furthermore there will be an interview about the medical history, a physical examination including blood pressure- and pulse-measurements after brief rest-period and a hemogram with determination of the target parameters. In the first group there will be two blood-lettings of 500ml, one at the beginning of the study and another after 6 weeks time. The patients will not receive medication reducing the blood pressure. Patients who are between 30 and 70 years of age and suffer from known, yet so far not pharmacologically treated high blood pressure, with values between 140 and 159 mmHg syst. and between 90 and 99mmHg diast., can participate in the study. Patients with blood pressure values between 160 and 179 mmHg syst. and between 100 and 109 mmHg diast. can only participate if they reject pharmacologic therapy because of intolerances to drugs (twofoldly documented in specialist-consultation by cardiologist or nephrologist). Participation in the study is not possible if in the first 24h-blood pressure measurement there are values found higher than 220/115 mmHg or if the patient is participating in other studies at the same time. Neither if the patient is suffering from acute infections or is pregnant. Furthermore patients who suffer from coagulation disorder or patients who take pharmacological anticoagulants cannot participate in the study. Moreover patient with an elevated cardiovascular risk because of known coronary heart disease, renal insufficiency, known diabetes mellitus or known retinopathy cannot participate in the study. Neither can patients with known stenosis of the common carotid artery, or patients who have suffered from transient ischemic attack or cerebral infarction before.

Brief summary in scientific language

There is a need for effective non-pharmacological therapy on arterial hypertension. The aim of this controlled-randomized monocentric clinical parallel-group study is to ascertain if blood-letting can induce the reduction of blood pressure levels and other cardio-vascular risk parameters in patients with arterial hypertension. The study continues during a period of 8 weeks with a total of 60 patients (i.e. 30 patients per group). At the beginning and at the end of the study there will be an ambulatory 24-hour blood pressure measurement. Furthermore there will be an anamnesis, a physical examination including RR- and pulse-measurements after a brief resting-period, an evaluation of the ankle-brachial index and a hemogram with determination of the target parameters. In the intervention group there will be two phlebotomies withdrawing 500 ml of blood each time, one at the beginning of the study and another after 6 weeks time. The patients will not receive medication reducing the blood pressure. Primary target parameter: Alteration of the 24-hour blood pressure measurement (24h-average), baseline vs. termination after 8 weeks; Secondary target parameter: Systolic blood pressure after resting-period (average of 3 measurements), diastolic blood pressure after resting-period (average of 3 measurements), heart rate after resting-period (average of 3 measurements), blood lipids / cardiovascular risk markers: 1. serum ferritin, 2. hematocrit, 3. serum iron, 4. triglycerides, 5. LDL cholesterol, 6. HDL cholesterol; inclusion criteria: - 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). exclusion criteria: - 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