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Trial record 6 of 21 for:    Open Studies | "Hypotension, Orthostatic"
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Assessment of Hand-grip in the Prevention of Postural Orthostatic Hypotension

This study is not yet open for participant recruitment.
Verified January 2012 by Tel-Aviv Sourasky Medical Center
Sponsor:
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT01521221
First received: August 15, 2011
Last updated: January 25, 2012
Last verified: January 2012
History of Changes
  Purpose

The study is aimed to assess the efficacy of hand-grip in preventing orthostatic hypotension in 20 patients diagnosed with autonomic failure. Five healthy subjects will be studied for comparison. The investigators will evaluate the subjects while on tilt table for 10 minutes and than while mounted from lying down to 70 degrees for additional 10 minutes. Blood pressure, heart rate and symptoms will be continuously measured. First study will evaluate the blood pressure changes. Second measure will include hand-grip maneuver 1 minute before the erect positon. Trans cranial Doppler will assess the intracranial blood flow during the position changes.


Condition Intervention Phase
Orthostatic Hypotension
 Other: Hand grip maneuver
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Assessment of Hand-grip in the Prevention of Postural Orthostatic Hypotension

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • Change in orthostatic blood fall after tilting with and without hand grip. [ Time Frame: 10 minutes after tilting the subjects. ] [ Designated as safety issue: No ]
    Patients will be tilted to 70 degrees twice. Hand grip maneuver will be performed 1 minute before the second tilt study and the differences in blood pressure changes [baseline-end tilt (mmHg)] will be compared between the two studies and to those obtained from a healthy control group.


Secondary Outcome Measures:
  • Change in the intracranial blood flow after tilting with and without hand grip. [ Time Frame: 10 minutes after tilting. ] [ Designated as safety issue: No ]
    Intracranial blood flow will be evaluated by transcranial doppler at baseline and after tilting. Differences will be compared [peak systolic flow (PSW) cm/sec], after tilting with and without prior hand grip and in comparison to tilting a control group.


Estimated Enrollment: 20
Study Start Date: April 2012
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Patients
Patients with autonomic failure.
 Other: Hand grip maneuver
Hand grip on blood pressue cuff slightly inflated at 50-70% of maximal force for 1 minute
Experimental: Healthy subjects
Control group
 Other: Hand grip maneuver
Hand grip on blood pressue cuff slightly inflated at 50-70% of maximal force for 1 minute

Detailed Description:

Study 1:

10 minutes lying on the tilt table. Performing TCD study at 10 minutes. Raising the tilt table to 70 degrees. Performing TCD study 5 minutes after tilting. Measuring blood pressure and symptoms for 10 minutes. Returning the tilt bed to supine position.

Study 2. in continue with study 1:

10 minutes lying on the tilt table. Performing TCD study at 10 minutes. Performing hand-grip at 50-70% grip force for 1 minute Raising the tilt table to 70 degrees. Performing TCD study 5 minutes after tilting. Measuring blood pressure and symptoms for 10 minutes. Returning the tilt bed to supine position.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Man or women
  • 18 years of age or older
  • Diagnosed with orthostatic hypotension due to Parkinson's disease, multiple system atrophy or pure autonomic failure
  • Orthostatic hypotension is not due to drugs, any heart disorder, anemia or dehydration

Exclusion Criteria:

  • Pregnant or breast feeding
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01521221

Locations
Israel
Movement disorders unit, the Department of Neurology, Sourasky Medical Center Not yet recruiting
Tel Aviv, Israel, 64239
Contact: Amnon Mosek, MD     972-3-6974874     mosek@tasmc.health.gov.il    
Contact: Tania Gurevitch, MD     972-3-6974912     tanyag@tasmc.health.gov.il    
Principal Investigator: Amnon Mosek, MD            
Sub-Investigator: Tanya Gurevitch, MD            
Sub-Investigator: Hen Halevi, MD            
Sub-Investigator: Marina Dano, MD            
Sub-Investigator: Eli Atnasova, MD            
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
Principal Investigator: Amnon Mosek, MD Deputy Chief, the Department of Neurology, Sourasky Medical Center
  More Information

No publications provided

Responsible Party: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT01521221     History of Changes
Other Study ID Numbers: TASMC-08-AM-462-CTIL
Study First Received: August 15, 2011
Last Updated: January 25, 2012
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Hypotension
Hypotension, Orthostatic
Vascular Diseases
Cardiovascular Diseases
 Orthostatic Intolerance
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on June 18, 2013