The Effect of Yoga on Cardiac Sympathetic Innervation Evaluated by I-123 mIBG
18. März 2018 aktualisiert von: Mehran Attari, University of Cincinnati
The purpose of this study is to evaluate if yoga practice will reduce cardiac sympathetic activity and subsequently cardiac arrhythmias.
Studienübersicht
Status
Zurückgezogen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Subjects with reduced ejection fraction will be randomized to 8 weeks Yoga training (1 in class session and home practice) vs. no Yoga.
They will undergo holter monitoring, cardiac device interrogation, and I-123 mIBG imaging at the beginning and end of the study.
Studientyp
Interventionell
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
Ohio
-
Cincinnati, Ohio, Vereinigte Staaten, 45219
- University of Cincinnati Medical Center
-
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
Inclusion Criteria:
- Negative pregnancy test in females
- Ejection Fraction </= 40% assessed by echocardiogram within the last 12 months
- Stable dose of heart failure medications including afterload reducing medication such as ACE-I, ARB and hydralazine; beta blockers; digoxin and aldosterone antagonist for at least 4 months and no anticipated changes for 8 weeks. (i.e. no greater than a 50% dose change within the past month)
- Has an implantable pacemaker or ICD
- NYHA II-IV
Exclusion Criteria:
- pregnant or lactating female
- females without a pregnancy test
- co-administration of a positive inotrope (i.e. milrinone or dobutamine)
- history of significant medical non-compliance
- unwilling to adhere to the protocol
- Orthopedic limitation making yoga participation difficult
- Underlying cardiac rhythm other than sinus rhythm
- Recent history within 6 months prior to enrollment of unstable coronary artery disease (unstable angina, recent heart attack, recent revascularization, or decompensated heart failure)
- implantation of a cardiac resynchronization therapy device in the past 3 months.
- TIA, CVA, or major surgery in the past 3 months
- iodine or adreview (123-MIBG) allergy
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Kein Eingriff: No yoga training
This will be the control arm.
The patients in this arm will not receive any yoga training.
They will be continued on all their home, guideline-directed heart failure medications.
They will undergo the same baseline and study completion evaluation as the treatment arm, including an I-123 MIBG scan, 24-hour holter monitoring and device interrogation.
|
|
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Experimental: Yoga training
The patients in this arm will receive yoga training.
This includes weekly group yoga sessions consisting of breathing exercises, yoga poses, and relaxation and meditation lasting for about 80-90 minutes total.
Patients will be asked to do home yoga practices at least twice a week and to document the date and time.
Patients in this arm will have the same baseline and study completion evaluation as the control arm, including an I-123 MIBG scan, 24-hour holter monitoring and device interrogation.
|
Subjects will complete in class yoga training weekly for 8 weeks with additional practice at home
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Cardiac sympathetic activity following yoga training
Zeitfenster: 8 weeks
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A comparison of of the I-123 MIBG heart to mediastinal uptake ratio at baseline and completion of the yoga training.
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8 weeks
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Relationship between I-123MIBG heart-to-mediastinal ratios and the total atrial and ventricular arrhythmia burden.
Zeitfenster: 8 weeks
|
Association between heart to mediastinum ration and ventricular arrhythmia burden
|
8 weeks
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Hauptermittler: Mehran Attari, University of Cincinnati
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
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Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
30. September 2017
Primärer Abschluss (Tatsächlich)
27. Oktober 2017
Studienabschluss (Tatsächlich)
27. Oktober 2017
Studienanmeldedaten
Zuerst eingereicht
20. Juli 2017
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
20. Juli 2017
Zuerst gepostet (Tatsächlich)
24. Juli 2017
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
20. März 2018
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
18. März 2018
Zuletzt verifiziert
1. März 2018
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 2015-7643
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