Mechanisms of Increased Ambulatory Blood Pressure in Patients With Intradialytic Hypertension

NCT ID: NCT01862497

Last Updated: 2018-05-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 76 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2018-04-30

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.

Conditions

Intradialytic Hypertension

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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)

Carvedilol vs. Prazosin

Intervention Type: DRUG

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

Carvedilol vs. Prazosin

Intervention Type: DRUG

Interventions

Carvedilol vs. Prazosin

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

NIH

Sponsor Role: collaborator

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Peter Van Buren

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 35999520 (View on PubMed)

Other Identifiers

STU 052012-029

Identifier Type: -

Identifier Source: org_study_id