Clinical trial NCT01862497: Mechanisms of Increased Ambulatory Blood Pressure in Patients With Intradialytic Hypertension
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intradialytic Hypertension
Keywords: Intradialytic Hypertension
Hemodialysis
Hypertension
Extracellular Volume
Endothelial Cell Dysfunction
Endothelin 1
Carvedilol
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2013-05-24
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study population includes hypertensive hemodialysis patients.

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.


Eligibility 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

Primary outcomes:
measure: Ratio of Extracellular Body Water to Total Body Water
timeFrame: Expected recruitment is 4-5 years
Secondary outcomes:
measure: Change in Endothelin-1 from pre to post dialysis
timeFrame: Expected recruitment is 4-5 years
Other outcomes:
measure: Change in Vascular Resistance from pre to post dialysis
timeFrame: Expected recruitment is 4-5 years
measure: Change in Asymmetric Dimethylarginine From pre to post dialysis
timeFrame: Expected recruitment is 4-5 years
measure: Change in Angiotensin II from pre to post dialysis
timeFrame: Expected recruitment is 4-5 years
Locations:
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center at Dallas
state: Texas
Study officials:
References:
citation: Jung J, Jeon-Slaughter H, Nguyen H, Patel J, Sambandam KK, Shastri S, Van Buren PN. Hyperphosphatemia and its relationship with blood pressure, vasoconstriction, and endothelial cell dysfunction in hypertensive hemodialysis patients. BMC Nephrol. 2022 Aug 23;23(1):291. doi: 10.1186/s12882-022-02918-0.