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Mechanisms of Increased Ambulatory Blood Pressure in Patients With Intradialytic Hypertension

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ClinicalTrials.gov Identifier: NCT01862497
Recruitment Status : Completed
First Posted : May 24, 2013
Last Update Posted : May 1, 2018
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Peter Van Buren, University of Texas Southwestern Medical Center

Brief Summary:
The purpose of this study is 1) to determine what physiologic factors (extracellular fluid overload or vasoconstriction) contribute more to increased blood pressure levels between dialysis treatments in hemodialysis patients whose blood pressure increases and decreases during hemodialysis and 2) to determine whether carvedilol provides better control of blood pressure between dialysis treatments than prazosin in patients whose blood pressure increases during dialysis.

Condition or disease Intervention/treatment
Intradialytic Hypertension Drug: Carvedilol vs. Prazosin

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Study Type : Observational
Actual Enrollment : 76 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Mechanism of Increased Ambulatory Blood Pressure in Patients With Intradialytic Hypertension and Hemodialysis Controls: A Case Control Study and Crossover Trial Comparing Carvedilol and Prazosin Hydrochloride
Study Start Date : January 2013
Actual Primary Completion Date : April 2018
Actual Study Completion Date : April 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Carvedilol (for Aim 3 only)

Eligible case subjects from aims 1-2 will participate in a randomized crossover study where each subject will receive carvedilol and prazosin for 8 weeks each(under randomized treatment sequence) with a 1 week washout period included in between treatments.

The first arm will include subjects that are assigned to the randomization sequence: Carvedilol x 8 weeks (titrated up to 50 mg po bid), washout x 1 week, Prazosin x 8 weeks (titrated up to 16 mg daily)

Drug: Carvedilol vs. Prazosin
Prazosin (for Aim 3 only)

Eligible case subjects from aims 1-2 will participate in a randomized crossover study where each subject will receive carvedilol and prazosin for 8 weeks each(under randomized treatment sequence) with a 1 week washout period included in between treatments.

The first arm will include subjects that are assigned to the randomization sequence: Prazosin x 8 weeks, washout x 1 week, Carvedilol x 8 weeks

Drug: Carvedilol vs. Prazosin



Primary Outcome Measures :
  1. Ratio of Extracellular Body Water to Total Body Water [ Time Frame: Expected recruitment is 4-5 years ]

Secondary Outcome Measures :
  1. Change in Endothelin-1 from pre to post dialysis [ Time Frame: Expected recruitment is 4-5 years ]

Other Outcome Measures:
  1. Change in Vascular Resistance from pre to post dialysis [ Time Frame: Expected recruitment is 4-5 years ]
  2. Change in Asymmetric Dimethylarginine From pre to post dialysis [ Time Frame: Expected recruitment is 4-5 years ]
  3. Change in Angiotensin II from pre to post dialysis [ Time Frame: Expected recruitment is 4-5 years ]

Biospecimen Retention:   Samples Without DNA
Serum collection for measurement of endothelin-1, asymetic dimethylarginine


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This study population includes hypertensive hemodialysis patients.
Criteria

Inclusion Criteria (for Aims 1 and 2):

  • age more than 18 years
  • Hypertension defined as systolic blood pressure more than 140 mmHg before dialysis or more than 130 mmHg after dialysis
  • For case subjects with intradialytic hypertension: systolic blood pressure increase more than 10 mmHg from pre to post dialysis in at least 4 out of 6 screening treatments
  • For control subjects: systolic blood pressure decrease more than 10 mmHg from pre to post dialysis in at least 4 out of 6 screening treatments

Inclusion criteria for Aim 3 includes the case subjects described above.

Exclusion Criteria:

For Aims 1 and 2:

  • Hemodialysis vintage less than 1 month
  • Amputated arm or leg
  • Presence of cardiac defibrillator or pacemaker
  • Presence of large metal prosthesis
  • Failure to achieve dry weight

For Case subjects participating in Aim 3:

  • Patients with a specific indication for beta blocker therapy including systolic heart failure, history of myocardial infarction, history of tachyarrhythmia or angina being managed with beta blocker therapy.
  • Patients with contraindications to beta blockade including bradycardia (heart rate less than 60 beats per minute) while not on a pulse lowering drug, severe reactive airway disease, prior intolerance to beta blocker therapy
  • Prior intolerance to alpha blocker therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01862497


Locations
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United States, Texas
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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Responsible Party: Peter Van Buren, Assistant Professor, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01862497     History of Changes
Other Study ID Numbers: STU 052012-029
First Posted: May 24, 2013    Key Record Dates
Last Update Posted: May 1, 2018
Last Verified: April 2018
Keywords provided by Peter Van Buren, University of Texas Southwestern Medical Center:
Intradialytic Hypertension
Hemodialysis
Hypertension
Extracellular Volume
Endothelial Cell Dysfunction
Endothelin 1
Carvedilol
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Carvedilol
Prazosin
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antihypertensive Agents
Antioxidants
Protective Agents
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents
Vasodilator Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists