Mechanisms of Increased Ambulatory Blood Pressure in Patients With Intradialytic Hypertension

NCT01862497 | Completed

• 1 other identifier: STU 052012-029
• Study Type: observational
• Target: 76
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Ratio of Extracellular Body Water to Total Body Water

  Expected recruitment is 4-5 years

Secondary Outcomes (1)

• Change in Endothelin-1 from pre to post dialysis

  Expected recruitment is 4-5 years

Other Outcomes (3)

• Change in Vascular Resistance from pre to post dialysis

  Expected recruitment is 4-5 years

• Change in Asymmetric Dimethylarginine From pre to post dialysis

  Expected recruitment is 4-5 years

• Change in Angiotensin II from pre to post dialysis

  Expected recruitment is 4-5 years

Study Arms (2)

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)

Drug: Carvedilol vs. Prazosin

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

Drug: Carvedilol vs. Prazosin

Interventions

Carvedilol vs. Prazosin DRUG

Carvedilol (for Aim 3 only); Prazosin (for Aim 3 only)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study population includes hypertensive hemodialysis patients.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, 75390, United States

Location

Related Publications (1)

• 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.

  PMID: 35999520 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum collection for measurement of endothelin-1, asymetic dimethylarginine

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 18, 2013
• First Posted: May 24, 2013
• Study Start: January 1, 2013
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: May 1, 2018

Record last verified: 2018-04

Locations

US (1)