Hypertonia
Conditions
Brief summary
The objective of this clinical study is to evaluate the influence of the Great autohemotherapy with oxygen-ozone (hyperbaric ozone therapy ) to describe the cardiovascular system in patients with resistant hypertension. The primary endpoint is the change in mean blood pressure after 10 treatments . In addition, data are collected on the immune system as well as for food and sleep quality.
Interventions
None listed
Sponsors
Herrmann Apparatebau GmbH
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Resistant Hypertension \> 140 / \> 90mmHg * Inclusion age : 45 + * Regular monitoring of blood levels considered * pre-medication to lower blood pressure for at least 3 weeks before the preliminary investigation consistent * Men and Women
Exclusion criteria
* derailed diabetes * renal impairment , renal creatinine clear \<50 ml * Non - austherapierte cancer / tumor patients * Non - adjusted thyroid dysfunction * BMI\> 35 * LVEF \<limit ( 35% ) * Peripheral AVK ( ABI - measurement ) \> Stage II * regurgitation \> Stage I * abdominal aneurysm * infections * acute febrile infections with temperature \> 38.5 ° C * COPD and asthma to stage III * dyspnea NYHA \> Stage III * z.n. Stroke shorter than 12 weeks * Acute liver failure * Acute Apoplexy * Severe poisoning * drug addiction * hyperthyroidism * Hypotension * hypocalcemia * hypoglycemia * ozone allergy * pregnancy * clotting problems ( hemophilia ) * pre-existing condition with hemoglobin \< 9mg/dl * Fresh myocardial infarction * Internal bleeding * thrombocytopenia * Acute alcohol * Citrus allergy when using sodium citrate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of blood pressure | 3 months | Primary endpoint is, that there is a changing of the middle blood pressure after 10 treatments. The blood pressure will get messured at all patients which get treated with oxygen-ozone. The aim is reached, if there is a reduction of the middle blood pressure after 10 treatments by 10 mmHg compared to the blood pressure by the patients at the baseline at beginning. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of pulse | 3 months | The Pulse will be measured at each follow-up. It will be measured 3 times at the dominate arm. |
| Change of blood count, liver and nephrew values | 3 months | The change of blood counts, liver and nephrew values serves as a sign for change of immune activity in a patient. Furthermore potential negative effects will be reportet as an adverse event. |
| Change of liver and nephrew values | 3 months | — |
| Change of life and Sleeping quality | 3 months | Change of life and sleeping quality will be measured in a 7 scale. This questionnaire is to fill in by the patient. |
Countries
Germany
Outcome results
None listed