Intradialytic Hypertension | Mechanisms of Increased Ambulatory Blood Pressure in Patients With Intradialytic Hypertension
Intradialytic Hypertension research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Carvedilol vs. Prazosin
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
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)
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
Start Date: January 2013
Completed Date: July 2018
Primary Outcome: Ratio of Extracellular Body Water to Total Body Water
Secondary Outcome: Change in Endothelin-1 from pre to post dialysis
Study sponsors, principal investigator, and references
Lead Sponsor: University of Texas Southwestern Medical Center
Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)