The effects of baroreflex activation therapy on blood pressure and sympathetic function in patients with refractory hypertension: the rationale and design of the Nordic BAT study
Objective: To explore the effects of baroreflex activation therapy (BAT) on hypertension in patients with treatment resistant or refractory hypertension. Methods: This investigator-initiated randomized, double-blind, 1:1 parallel-design clinical trial will include 100 patients with refractory hypert...
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| Veröffentlicht in: | BLOOD PRESSURE 2017-09, Vol.26 (5), p.294-302 |
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| creator | Gordin, Daniel Fadl Elmula, Fadl Elmula M. Andersson, Bert Gottsäter, Anders Elf, Johan Kahan, Thomas Christensen, Kent Lodberg Vikatmaa, Pirkka Vikatmaa, Leena Bastholm Olesen, Thomas Groop, Per-Henrik Olsen, Michael Hecht Tikkanen, Ilkka |
| description | Objective: To explore the effects of baroreflex activation therapy (BAT) on hypertension in patients with treatment resistant or refractory hypertension.
Methods: This investigator-initiated randomized, double-blind, 1:1 parallel-design clinical trial will include 100 patients with refractory hypertension from 6 tertiary referral hypertension centers in the Nordic countries. A Barostim Neo System will be implanted and after 1 month patients will be randomized to either BAT for 16 months or continuous pharmacotherapy (BAT off) for 8 months followed by BAT for 8 months. A second randomization will take place after 16 months to BAT or BAT off for 3 months. Eligible patients have a daytime systolic ambulatory blood pressure (ABPM) of ≥145 mm Hg, and/or a daytime diastolic ABPM of ≥95 mm Hg after witnessed drug intake (including ≥3 antihypertensive drugs, preferably including a diuretic).
Results: The primary end point is the reduction in 24-hour systolic ABPM by BAT at 8 months, as compared to pharmacotherapy. Secondary and tertiary endpoints are effects of BAT on home and office blood pressures, measures of indices of cardiac and vascular structure and function during follow-up, and safety.
Conclusions: This academic initiative will increase the understanding of mechanisms and role of BAT in the refractory hypertension. |
| doi_str_mv | 10.1080/08037051.2017.1332477 |
| format | Article |
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Methods: This investigator-initiated randomized, double-blind, 1:1 parallel-design clinical trial will include 100 patients with refractory hypertension from 6 tertiary referral hypertension centers in the Nordic countries. A Barostim Neo System will be implanted and after 1 month patients will be randomized to either BAT for 16 months or continuous pharmacotherapy (BAT off) for 8 months followed by BAT for 8 months. A second randomization will take place after 16 months to BAT or BAT off for 3 months. Eligible patients have a daytime systolic ambulatory blood pressure (ABPM) of ≥145 mm Hg, and/or a daytime diastolic ABPM of ≥95 mm Hg after witnessed drug intake (including ≥3 antihypertensive drugs, preferably including a diuretic).
Results: The primary end point is the reduction in 24-hour systolic ABPM by BAT at 8 months, as compared to pharmacotherapy. Secondary and tertiary endpoints are effects of BAT on home and office blood pressures, measures of indices of cardiac and vascular structure and function during follow-up, and safety.
Conclusions: This academic initiative will increase the understanding of mechanisms and role of BAT in the refractory hypertension.</description><identifier>ISSN: 0803-7051</identifier><identifier>EISSN: 1651-1999</identifier><identifier>DOI: 10.1080/08037051.2017.1332477</identifier><identifier>PMID: 28595464</identifier><language>eng</language><publisher>England: Taylor & Francis</publisher><subject>Adolescent ; Adult ; Aged ; Ambulatory blood pressure measurement ; Baroreflex ; baroreflex activation therapy ; baroreflex sensitivity ; Blood Pressure ; Cardiac and Cardiovascular Systems ; cardiac autonomic function ; Cardiology and Cardiovascular Disease ; Clinical Medicine ; diabetes ; Double-Blind Method ; Electric Stimulation Therapy - methods ; Heart - physiopathology ; heart rate variability ; HEART-FAILURE ; HEMODYNAMICS ; Humans ; Hypertension - physiopathology ; Hypertension - therapy ; Kardiologi ; Kardiologi och kardiovaskulära sjukdomar ; Klinisk medicin ; MANAGEMENT ; Medical and Health Sciences ; Medicin och hälsovetenskap ; Middle Aged ; myocardial infarction ; NERVE ; peripheral vascular disease ; Prostheses and Implants ; refractory hypertension ; RESISTANT HYPERTENSION ; RHEOS PIVOTAL TRIAL ; STIMULATION ; SYSTEM ; Young Adult</subject><ispartof>BLOOD PRESSURE, 2017-09, Vol.26 (5), p.294-302</ispartof><rights>2017 Informa UK Limited, trading as Taylor & Francis Group 2017</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c577t-af0335cd66aeb8d2503b8e536bacd742a8c3bee9123e95e1492a690eeabc096a3</citedby><cites>FETCH-LOGICAL-c577t-af0335cd66aeb8d2503b8e536bacd742a8c3bee9123e95e1492a690eeabc096a3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,776,780,881,27903,27904</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/28595464$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink><backlink>$$Uhttps://gup.ub.gu.se/publication/257060$$DView record from Swedish Publication Index$$Hfree_for_read</backlink><backlink>$$Uhttps://lup.lub.lu.se/record/15d7dbed-088e-4f82-9f46-f27f8d173034$$DView record from Swedish Publication Index$$Hfree_for_read</backlink><backlink>$$Uhttp://kipublications.ki.se/Default.aspx?queryparsed=id:136407777$$DView record from Swedish Publication Index$$Hfree_for_read</backlink></links><search><creatorcontrib>Gordin, Daniel</creatorcontrib><creatorcontrib>Fadl Elmula, Fadl Elmula M.</creatorcontrib><creatorcontrib>Andersson, Bert</creatorcontrib><creatorcontrib>Gottsäter, Anders</creatorcontrib><creatorcontrib>Elf, Johan</creatorcontrib><creatorcontrib>Kahan, Thomas</creatorcontrib><creatorcontrib>Christensen, Kent Lodberg</creatorcontrib><creatorcontrib>Vikatmaa, Pirkka</creatorcontrib><creatorcontrib>Vikatmaa, Leena</creatorcontrib><creatorcontrib>Bastholm Olesen, Thomas</creatorcontrib><creatorcontrib>Groop, Per-Henrik</creatorcontrib><creatorcontrib>Olsen, Michael Hecht</creatorcontrib><creatorcontrib>Tikkanen, Ilkka</creatorcontrib><creatorcontrib>Nordic BAT Study Group</creatorcontrib><creatorcontrib>The Nordic BAT Study Group</creatorcontrib><title>The effects of baroreflex activation therapy on blood pressure and sympathetic function in patients with refractory hypertension: the rationale and design of the Nordic BAT study</title><title>BLOOD PRESSURE</title><addtitle>Blood Press</addtitle><description>Objective: To explore the effects of baroreflex activation therapy (BAT) on hypertension in patients with treatment resistant or refractory hypertension.
Methods: This investigator-initiated randomized, double-blind, 1:1 parallel-design clinical trial will include 100 patients with refractory hypertension from 6 tertiary referral hypertension centers in the Nordic countries. A Barostim Neo System will be implanted and after 1 month patients will be randomized to either BAT for 16 months or continuous pharmacotherapy (BAT off) for 8 months followed by BAT for 8 months. A second randomization will take place after 16 months to BAT or BAT off for 3 months. Eligible patients have a daytime systolic ambulatory blood pressure (ABPM) of ≥145 mm Hg, and/or a daytime diastolic ABPM of ≥95 mm Hg after witnessed drug intake (including ≥3 antihypertensive drugs, preferably including a diuretic).
Results: The primary end point is the reduction in 24-hour systolic ABPM by BAT at 8 months, as compared to pharmacotherapy. Secondary and tertiary endpoints are effects of BAT on home and office blood pressures, measures of indices of cardiac and vascular structure and function during follow-up, and safety.
Conclusions: This academic initiative will increase the understanding of mechanisms and role of BAT in the refractory hypertension.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Aged</subject><subject>Ambulatory blood pressure measurement</subject><subject>Baroreflex</subject><subject>baroreflex activation therapy</subject><subject>baroreflex sensitivity</subject><subject>Blood Pressure</subject><subject>Cardiac and Cardiovascular Systems</subject><subject>cardiac autonomic function</subject><subject>Cardiology and Cardiovascular Disease</subject><subject>Clinical Medicine</subject><subject>diabetes</subject><subject>Double-Blind Method</subject><subject>Electric Stimulation Therapy - methods</subject><subject>Heart - physiopathology</subject><subject>heart rate variability</subject><subject>HEART-FAILURE</subject><subject>HEMODYNAMICS</subject><subject>Humans</subject><subject>Hypertension - physiopathology</subject><subject>Hypertension - therapy</subject><subject>Kardiologi</subject><subject>Kardiologi och kardiovaskulära sjukdomar</subject><subject>Klinisk medicin</subject><subject>MANAGEMENT</subject><subject>Medical and Health Sciences</subject><subject>Medicin och hälsovetenskap</subject><subject>Middle Aged</subject><subject>myocardial infarction</subject><subject>NERVE</subject><subject>peripheral vascular disease</subject><subject>Prostheses and Implants</subject><subject>refractory hypertension</subject><subject>RESISTANT HYPERTENSION</subject><subject>RHEOS PIVOTAL TRIAL</subject><subject>STIMULATION</subject><subject>SYSTEM</subject><subject>Young Adult</subject><issn>0803-7051</issn><issn>1651-1999</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2017</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>DOA</sourceid><recordid>eNp9kstu1TAQhiMEoqXwCCAv2Zxix7eEFaXiUqmCzWFtOfb4nJScONgJJa_FEzI5FyQWdGHFmnzzzUT5i-Ilo5eMVvQNHq6pZJclZfqScV4KrR8V50xJtmJ1XT8uzhdmtUBnxbOc7yhFjNKnxVlZyVoKJc6L3-stEAgB3JhJDKSxKSYIHfwi1o3tTzu2sSfjFpIdZoLXpovRkyFBzlMCYntP8rwbLCJj60iYerdvaXuCxRZ69N6345agNaEyppls5wHSCH1G8O0iJ2k_x3YHoYfcbvplneXdl5g8mt9frUkeJz8_L54E22V4cXxeFN8-flhff17dfv10c311u3JS63FlA-VcOq-UhabypaS8qUBy1VjntSht5XgDULOSQy2Bibq0qqYAtnG0VpZfFDcHr4_2zgyp3dk0m2hbsy_EtDE24Td3YFSgVJYM27kQTDmrNOdBBK60trbR6FodXPkehqn5x3YsfccbGFGrUgjkb__Ld9OAp8GzNDDptW_AG1pV2B6q0tRBKBNKHSrPNMeVHhy_QR2WNntbKTVVFPnXB35I8ccEeTS7NjvoOttDnLJhNa0Ex8xxROUBdSnmjD_5r5xRsyTVnJJqlqSaY1Kx79VxxNTscP1T1ymaCLw7AG0fYtrZ-5g6b0Y7dzFhknrXZsMfnvEH7Wb8Jw</recordid><startdate>20170903</startdate><enddate>20170903</enddate><creator>Gordin, Daniel</creator><creator>Fadl Elmula, Fadl Elmula M.</creator><creator>Andersson, Bert</creator><creator>Gottsäter, Anders</creator><creator>Elf, Johan</creator><creator>Kahan, Thomas</creator><creator>Christensen, Kent Lodberg</creator><creator>Vikatmaa, Pirkka</creator><creator>Vikatmaa, Leena</creator><creator>Bastholm Olesen, Thomas</creator><creator>Groop, Per-Henrik</creator><creator>Olsen, Michael Hecht</creator><creator>Tikkanen, Ilkka</creator><general>Taylor & Francis</general><general>Taylor & Francis Group</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>ADTPV</scope><scope>AOWAS</scope><scope>F1U</scope><scope>D95</scope><scope>DOA</scope></search><sort><creationdate>20170903</creationdate><title>The effects of baroreflex activation therapy on blood pressure and sympathetic function in patients with refractory hypertension: the rationale and design of the Nordic BAT study</title><author>Gordin, Daniel ; Fadl Elmula, Fadl Elmula M. ; Andersson, Bert ; Gottsäter, Anders ; Elf, Johan ; Kahan, Thomas ; Christensen, Kent Lodberg ; Vikatmaa, Pirkka ; Vikatmaa, Leena ; Bastholm Olesen, Thomas ; Groop, Per-Henrik ; Olsen, Michael Hecht ; Tikkanen, Ilkka</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c577t-af0335cd66aeb8d2503b8e536bacd742a8c3bee9123e95e1492a690eeabc096a3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2017</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Aged</topic><topic>Ambulatory blood pressure measurement</topic><topic>Baroreflex</topic><topic>baroreflex activation therapy</topic><topic>baroreflex sensitivity</topic><topic>Blood Pressure</topic><topic>Cardiac and Cardiovascular Systems</topic><topic>cardiac autonomic function</topic><topic>Cardiology and Cardiovascular Disease</topic><topic>Clinical Medicine</topic><topic>diabetes</topic><topic>Double-Blind Method</topic><topic>Electric Stimulation Therapy - methods</topic><topic>Heart - physiopathology</topic><topic>heart rate variability</topic><topic>HEART-FAILURE</topic><topic>HEMODYNAMICS</topic><topic>Humans</topic><topic>Hypertension - physiopathology</topic><topic>Hypertension - therapy</topic><topic>Kardiologi</topic><topic>Kardiologi och kardiovaskulära sjukdomar</topic><topic>Klinisk medicin</topic><topic>MANAGEMENT</topic><topic>Medical and Health Sciences</topic><topic>Medicin och hälsovetenskap</topic><topic>Middle Aged</topic><topic>myocardial infarction</topic><topic>NERVE</topic><topic>peripheral vascular disease</topic><topic>Prostheses and Implants</topic><topic>refractory hypertension</topic><topic>RESISTANT HYPERTENSION</topic><topic>RHEOS PIVOTAL TRIAL</topic><topic>STIMULATION</topic><topic>SYSTEM</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Gordin, Daniel</creatorcontrib><creatorcontrib>Fadl Elmula, Fadl Elmula M.</creatorcontrib><creatorcontrib>Andersson, Bert</creatorcontrib><creatorcontrib>Gottsäter, Anders</creatorcontrib><creatorcontrib>Elf, Johan</creatorcontrib><creatorcontrib>Kahan, Thomas</creatorcontrib><creatorcontrib>Christensen, Kent Lodberg</creatorcontrib><creatorcontrib>Vikatmaa, Pirkka</creatorcontrib><creatorcontrib>Vikatmaa, Leena</creatorcontrib><creatorcontrib>Bastholm Olesen, Thomas</creatorcontrib><creatorcontrib>Groop, Per-Henrik</creatorcontrib><creatorcontrib>Olsen, Michael Hecht</creatorcontrib><creatorcontrib>Tikkanen, Ilkka</creatorcontrib><creatorcontrib>Nordic BAT Study Group</creatorcontrib><creatorcontrib>The Nordic BAT Study Group</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>SwePub</collection><collection>SwePub Articles</collection><collection>SWEPUB Göteborgs universitet</collection><collection>SWEPUB Lunds universitet</collection><collection>DOAJ Directory of Open Access Journals</collection><jtitle>BLOOD PRESSURE</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Gordin, Daniel</au><au>Fadl Elmula, Fadl Elmula M.</au><au>Andersson, Bert</au><au>Gottsäter, Anders</au><au>Elf, Johan</au><au>Kahan, Thomas</au><au>Christensen, Kent Lodberg</au><au>Vikatmaa, Pirkka</au><au>Vikatmaa, Leena</au><au>Bastholm Olesen, Thomas</au><au>Groop, Per-Henrik</au><au>Olsen, Michael Hecht</au><au>Tikkanen, Ilkka</au><aucorp>Nordic BAT Study Group</aucorp><aucorp>The Nordic BAT Study Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>The effects of baroreflex activation therapy on blood pressure and sympathetic function in patients with refractory hypertension: the rationale and design of the Nordic BAT study</atitle><jtitle>BLOOD PRESSURE</jtitle><addtitle>Blood Press</addtitle><date>2017-09-03</date><risdate>2017</risdate><volume>26</volume><issue>5</issue><spage>294</spage><epage>302</epage><pages>294-302</pages><issn>0803-7051</issn><eissn>1651-1999</eissn><abstract>Objective: To explore the effects of baroreflex activation therapy (BAT) on hypertension in patients with treatment resistant or refractory hypertension.
Methods: This investigator-initiated randomized, double-blind, 1:1 parallel-design clinical trial will include 100 patients with refractory hypertension from 6 tertiary referral hypertension centers in the Nordic countries. A Barostim Neo System will be implanted and after 1 month patients will be randomized to either BAT for 16 months or continuous pharmacotherapy (BAT off) for 8 months followed by BAT for 8 months. A second randomization will take place after 16 months to BAT or BAT off for 3 months. Eligible patients have a daytime systolic ambulatory blood pressure (ABPM) of ≥145 mm Hg, and/or a daytime diastolic ABPM of ≥95 mm Hg after witnessed drug intake (including ≥3 antihypertensive drugs, preferably including a diuretic).
Results: The primary end point is the reduction in 24-hour systolic ABPM by BAT at 8 months, as compared to pharmacotherapy. Secondary and tertiary endpoints are effects of BAT on home and office blood pressures, measures of indices of cardiac and vascular structure and function during follow-up, and safety.
Conclusions: This academic initiative will increase the understanding of mechanisms and role of BAT in the refractory hypertension.</abstract><cop>England</cop><pub>Taylor & Francis</pub><pmid>28595464</pmid><doi>10.1080/08037051.2017.1332477</doi><tpages>9</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | Adolescent Adult Aged Ambulatory blood pressure measurement Baroreflex baroreflex activation therapy baroreflex sensitivity Blood Pressure Cardiac and Cardiovascular Systems cardiac autonomic function Cardiology and Cardiovascular Disease Clinical Medicine diabetes Double-Blind Method Electric Stimulation Therapy - methods Heart - physiopathology heart rate variability HEART-FAILURE HEMODYNAMICS Humans Hypertension - physiopathology Hypertension - therapy Kardiologi Kardiologi och kardiovaskulära sjukdomar Klinisk medicin MANAGEMENT Medical and Health Sciences Medicin och hälsovetenskap Middle Aged myocardial infarction NERVE peripheral vascular disease Prostheses and Implants refractory hypertension RESISTANT HYPERTENSION RHEOS PIVOTAL TRIAL STIMULATION SYSTEM Young Adult |
| title | The effects of baroreflex activation therapy on blood pressure and sympathetic function in patients with refractory hypertension: the rationale and design of the Nordic BAT study |
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