Mechanisms of Increased Ambulatory Blood Pressure in Patients With Intradialytic Hypertension

Intradialytic Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01862497
• Other study ID #: STU 052012-029
• Status: Completed
• Start date: January 2013
• Est. completion date: April 2018

Study information

• Verified date: April 2018
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Intradialytic Hypertension

Intervention

Drug:
• Carvedilol vs. Prazosin

Locations

Country	Name	City	State
United States	University of Texas Southwestern Medical Center at Dallas	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Vascular Resistance from pre to post dialysis		Expected recruitment is 4-5 years
Other	Change in Asymmetric Dimethylarginine From pre to post dialysis		Expected recruitment is 4-5 years
Other	Change in Angiotensin II from pre to post dialysis		Expected recruitment is 4-5 years
Primary	Ratio of Extracellular Body Water to Total Body Water		Expected recruitment is 4-5 years
Secondary	Change in Endothelin-1 from pre to post dialysis		Expected recruitment is 4-5 years