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Completed

NCT Number: NCT01862497

Mechanisms of Increased Ambulatory Blood Pressure in Patients With Intradialytic Hypertension

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, 75390, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Carvedilol vs. Prazosin

Drug

Primary outcomes

  1. Ratio of Extracellular Body Water to Total Body Water

    Time frame: Expected recruitment is 4-5 years

Secondary outcomes

  1. Change in Endothelin-1 from pre to post dialysis

    Time frame: Expected recruitment is 4-5 years

Other outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
May 24, 2013
Registry last updated
May 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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