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Mechanisms of Increased Ambulatory Blood Pressure in Patients With Intradialytic Hypertension

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01862497
Enrollment
76
Registered
2013-05-24
Start date
2013-01-31
Completion date
2018-04-30
Last updated
2018-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intradialytic Hypertension

Keywords

Intradialytic Hypertension, Hemodialysis, Hypertension, Extracellular Volume, Endothelial Cell Dysfunction, Endothelin 1, Carvedilol

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.

Interventions

DRUGCarvedilol vs. Prazosin

Sponsors

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

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Ratio of Extracellular Body Water to Total Body WaterExpected recruitment is 4-5 years

Secondary

MeasureTime frame
Change in Endothelin-1 from pre to post dialysisExpected recruitment is 4-5 years

Other

MeasureTime frame
Change in Vascular Resistance from pre to post dialysisExpected recruitment is 4-5 years
Change in Asymmetric Dimethylarginine From pre to post dialysisExpected recruitment is 4-5 years
Change in Angiotensin II from pre to post dialysisExpected recruitment is 4-5 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026