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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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German Clinical Trials Register |
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Last refreshed on:
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8 April 2024 |
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Main ID: |
DRKS00004265 |
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Date of registration:
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23/07/2012 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Randomized controlled trial on the efficacy of bloodletting for arterial hypertension
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Scientific title:
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Randomized controlled trial on the efficacy of bloodletting for arterial hypertension |
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Date of first enrolment:
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30/07/2012 |
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Target sample size:
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60 |
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Recruitment status: |
Pending |
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URL:
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http://drks.de/search/en/trial/DRKS00004265 |
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Study type:
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interventional |
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Study design:
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Allocation: Randomized controlled study; Masking: Open (masking not used); Control: No treatment / Standard of care; Assignment: parallel; Study design purpose: treatment
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Phase:
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N/A
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Countries of recruitment
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Germany
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Contacts
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Name:
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Sabine
Saalfeld |
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Address:
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Königstraße 63
14109
Berlin
Germany |
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Telephone:
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030/80505 -659 |
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Email:
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S.Saalfeld@immanuel.de |
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Affiliation:
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Immanuel Krankenhaus Berlin Wannsee
Hochschulambulanz für Naturheilkunde der Charité Universitätsmedizin Abteilung für Naturheilkunde |
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Name:
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Andreas
Michalsen |
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Address:
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Königstraße 63
14109
Berlin
Germany |
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Telephone:
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030/80505 -691 |
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Email:
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a.michalsen@immanuel.de |
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Affiliation:
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Immanuel Krankenhaus Berlin Wannsee
Hochschulambulanz für Naturheilkunde der Charité Universitätsmedizin Abteilung für Naturheilkunde |
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Key inclusion & exclusion criteria
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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
Age minimum:
30 Years
Age maximum:
70 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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I10.0
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I10.0
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Intervention(s)
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Group 1: 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.
Group 2: untreated control-group
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Primary Outcome(s)
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Alteration of the 24-hour bloodpressure measurement (24h-average), baseline vs. termination after 8 weeks
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Secondary Outcome(s)
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Systolic bloodpressure after resting-period (average of 3 measurements),
diastolic bloodpressure 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;
baseline vs. termination after 8 weeks
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Secondary ID(s)
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U1111-1132-8579
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Source(s) of Monetary Support
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Karl und Vernika Carstens Stiftung
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Ethics review
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Status: Approved
Approval date: 22/06/2012
Contact:
ethikkommission@charite.de
Ethikkommission der Charité – Universitätsmedizin Berlin
(+49)30-450517222
ethikkommission@charite.de
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