Stop Vasodepressor Drugs in Reflex Syncope

NCT02137278 | Completed Phase 3

• 1 other identifier: ASL4/CARD/01
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

Investigate clinical effects (reduction of number of syncope and associate symptoms) of suspension of vasoactive drugs in patients affected by vasodepressor reflex syncope.

Conditions

Hypotensive Syncope

Keywords

Syncope; Presyncope; Vasoactive drugs; Hypotension; Carotid sinus massage; Tilt table test

Outcome Measures

Primary Outcomes (1)

• Recurrence of syncope or presyncope and adverse events

  Combined end-point of rate of patients with recurrence of (pre)syncope and adverse events

  From date of randomization until the date of first documented syncope or adverse event, whichever came first, assessed up to 2 years

Secondary Outcomes (2)

• Syncope

  From date of randomization until the date of first documented syncope or adverse event, whichever come first, assessed up to 2 years

• Presyncope

  From date of randomization until the date of first documented syncope or adverse event, whichever came first, assessed up to 2 years

Other Outcomes (1)

• Acute study

  1 month

Study Arms (2)

Stop/reduce vasoactive drugs

ACTIVE COMPARATOR

Discontinuation of any vasoactive therapy or reduction of vasoactive drug therapies as much as possible according to clinical judgment

Other: Stop/reduce vasoactive drugs

Vasoactive drug therapy

EXPERIMENTAL

Continue current vasoactive therapy

Drug: Vasoactive drug therapies

Interventions

Vasoactive drug therapies DRUG

Continue current vasoactive therapy

Also known as: Antihypertensive, Nitrates, Alpha-antagonists, Diuretics, Neuroleptic antidepressant, L-dopa antagonists

Vasoactive drug therapy

Stop/reduce vasoactive drugs OTHER

Discontinuation of any vasoactive therapy or reduction of vasoactive drug therapies as much as possible according to clinical judgment.

Also known as: Antihypertensive, Nitrates, Alpha-antagonists, Diuretics, Neuroleptic antidepressant, L-dopa antagonists

Stop/reduce vasoactive drugs

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients assuming chronic (\>1 year) vasoactive therapy affected by reflex recurrent (\>2 episodes) syncopes who have a positive dominant vasodepressor or mixed response to tilt table test and/or carotid sinus massage

You may not qualify if:

• Orthostatic hypotension defined as fall in systolic blood pressure \>20 mmHg during the first 3 minutes of active standing
• Competing diagnosis of syncope different from hypotensive reflex syncope
• Reflex syncope with negative response to carotid sinus massage and tilt table test
• Cardioinhibitory reflex syncope which requires permanent cardiac pacing
• Severe hypertension which requires treatment (\>150/95)
• Structured heart disease which requires hypotensive therapy in order to prevent acute heart failure
• Cardiac hypotensive therapy in order to prevent recurrences
• Previous stroke or transient ischemic attacks

Sponsors & Collaborators

• Gruppo Italiano Multidisciplinare per lo Studio della Sincope: lead

Study Sites (1)

Dipartimento di Cardiologia, Ospedali del Tigullio

Lavagna, 16032, Italy

Location

Related Publications (4)

• Gaggioli G, Brignole M, Menozzi C, Devoto G, Oddone D, Gianfranchi L, Gostoli E, Bottoni N, Lolli G. A positive response to head-up tilt testing predicts syncopal recurrence in carotid sinus syndrome patients with permanent pacemakers. Am J Cardiol. 1995 Oct 1;76(10):720-2. doi: 10.1016/s0002-9149(99)80207-0. No abstract available.

  PMID: 7572635 BACKGROUND

• Solari D, Maggi R, Oddone D, Solano A, Croci F, Donateo P, Brignole M. Clinical context and outcome of carotid sinus syndrome diagnosed by means of the 'method of symptoms'. Europace. 2014 Jun;16(6):928-34. doi: 10.1093/europace/eut283. Epub 2013 Sep 20.

  PMID: 24058183 RESULT

• Podoleanu C, Maggi R, Brignole M, Croci F, Incze A, Solano A, Puggioni E, Carasca E. Lower limb and abdominal compression bandages prevent progressive orthostatic hypotension in elderly persons: a randomized single-blind controlled study. J Am Coll Cardiol. 2006 Oct 3;48(7):1425-32. doi: 10.1016/j.jacc.2006.06.052. Epub 2006 Sep 14.

  PMID: 17010806 RESULT

• Brignole M, Menozzi C, Gaggioli G, Musso G, Foglia-Manzillo G, Mascioli G, Fradella G, Bottoni N, Mureddu R. Effects of long-term vasodilator therapy in patients with carotid sinus hypersensitivity. Am Heart J. 1998 Aug;136(2):264-8. doi: 10.1053/hj.1998.v136.89911.

  PMID: 9704688 RESULT

MeSH Terms

Conditions

Syncope; Hypotension

Interventions

Antihypertensive Agents; Nitrates; Diuretics

Condition Hierarchy (Ancestors)

Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiovascular Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Anions; Ions; Electrolytes; Inorganic Chemicals; Nitric Acid; Nitrogen Compounds; Organic Chemicals; Natriuretic Agents; Physiological Effects of Drugs

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2014
• First Posted: May 13, 2014
• Study Start: March 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 29, 2015

Record last verified: 2015-12

Locations

IT (1)